Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation (David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist)

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Are you a busy biotech scientist, trying to navigate the complex world of bioprocessing while fueling your passion for science? Join us on the Smart Biotech Scientist Podcast, where we're about to unravel the secrets to bioprocess mastery.

Hosted by a seasoned biotech leader and entrepreneur with over 15 years in the industry, this podcast is your compass through the maze of challenges. Picture yourself in the lab, deadlines looming, feeling like you're solving a puzzle with missing pieces. We've been there, too.

In this podcast, we simplify the journey to bioprocess mastery, providing practical solutions, deep dives into analytics, and inspiring conversations with biotech leaders. Imagine gaining insights from industry experts and belonging to a supportive community that fuels your growth.

Get ready for stories that resonate, solutions that empower, and questions that pique your curiosity. Don’t miss out!

►► Subscribe now, with new episodes dropping every Tuesday and Thursday.

Reignite your passion for science as we tackle challenges and simplify bioprocessing together. Join us on this exciting adventure!

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In this episode with Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific, we delve into the world of bioprocessing. Tom shares insights into the transformative power of rational media design.

From the complexities of bioprocess development to the game-changing potential of AI, this interview is a treasure trove of knowledge for both scientists and engineers.

You will learn:

- Learn about the evolution of priorities during bioprocess development, from speed to reliability, and how scientists must adapt accordingly.

- Discover the importance of a thoughtful, hypothesis-driven approach compared to a blind, random one, and how it can reveal valuable process knowledge.

- Explore the exciting future of bioprocessing, including the role of AI and in silico models, and the importance of combining technology with human reasoning.

Tune in to gain a deeper understanding of the critical role that rational media design plays in advancing the biotech industry.

Connect with Tom Fletcher:

LinkedIn: https://www.linkedin.com/in/tomfletcher2

Fujifilm Irvine Scientific: https://www.irvinesci.com

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Welcome to a fascinating Smart Biotech Scientist episode! In this conversation, we dive deep into the nuts and bolts of rational media development with our guest, Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific.

Together, we explore the immense potential of Rational Media Design and how it's transforming the industry.

Here are three major takeaways from this episode:

1. Define Your Goals: Tom emphasizes the importance of clearly defining your bioprocessing goals. Whether it's boosting cell growth or enhancing product quality, understanding your specific needs is the first crucial step.

2. Gain Process Understanding: Learn how to identify limiting factors in your process and generate hypotheses. Tom discusses how thinking through biochemical pathways and potential bottlenecks is key to achieving your goals.

3. Leverage Automation: Discover the future of bioprocessing with automated, closed systems that eliminate human intervention and ensure consistent, sterile media preparation. Tom shares insights into groundbreaking innovations that simplify and streamline the process.

Join us in unraveling the science behind bioprocessing and unlock the power of rational media design in this episode.

Don't miss out on the knowledge that could revolutionize your bioprocessing journey!

Connect with Tom Fletcher:

LinkedIn: https://www.linkedin.com/in/tomfletcher2

Fujifilm Irvine Scientific: https://www.irvinesci.com

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In this captivating episode, we delve into the world of biotech scale-up with the seasoned expert, Leonardo Sibilio, CSO at BetaPro Consulting and CEO of the Biotech Academy in Rome.

Discover how mastering the art of biotech scale-up can transform your journey from doubt to dominance.

Key Takeaways:

1. Early Planning is Paramount: Leonardo emphasizes the importance of initiating the scale-up process as early as possible. Waiting until later phases can lead to challenges and hinder progress. Early planning, including characterizing the cell line and ensuring stability, is key to a seamless transition from R&D to large-scale production.

2. Mindset Shift is Crucial: Successful scale-up requires a shift in mindset, especially for startups originating from academia. Transitioning from research to regulated environments demands precision, rigorous documentation, and an unwavering focus on producing life-changing medicines.

3. Embrace Learning and Structured Processes: Leonardo encourages the use of structured methodologies and tools like R or Python for better data analysis and visualization. Structured documentation and reporting are critical for regulatory compliance and efficient tech transfer.

Join us as we explore the challenges, pitfalls, and strategies of biotech scale-up, unlocking the secrets to mastering it without guesswork.

Whether you're a seasoned professional or new to the field, this episode provides valuable insights for anyone interested in bioprocess scale-up and commercialization.

Connect with Leonardo Sibilio:

LinkedIn: www.linkedin.com/in/leonardo-sibilio-9bb26320

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In today's episode, we continue our fascinating conversation with Leonardo Sibilio, CEO of Biotech Academy and CSO at BetaPro Consulting. We delve into the pivotal role of structured training in the dynamic biotech industry.

In this episode, you'll discover:

- Foundation of Success: Leonardo emphasizes the importance of a strong foundation in GMP and an understanding of biotech facility operations. Whether you're an aspiring employee or a seasoned professional, a solid knowledge base in these areas is the cornerstone of a successful career.

- Broaden Your Horizons: Biotech is a multifaceted industry. Leonardo advises listeners to be curious and embrace a wide range of skills. You'll thrive by gaining expertise in both upstream and downstream processes, as well as analytical methods. This adaptability is key to succeeding in today's rapidly evolving biotech landscape.

- Continuous Learning: In the ever-changing world of biotech, continuous learning is vital. Leonardo recommends staying updated with technical literature, online courses, and hands-on training. To excel, it's crucial to master the practical aspects of bioreactor assembly, autoclaving, and equipment operation.

Join Leonardo as he explores the exciting opportunities in biotech, and find out how to enhance your expertise.

If you're passionate about biotech and eager to take your career to new heights, this episode is a must-listen! Don't miss out on the valuable insights Leonardo shares on mastering biotech scale-up. Tune in now!

Connect with Leonardo Sibilio:

LinkedIn: www.linkedin.com/in/leonardo-sibilio-9bb26320

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In this insightful conversation, we explore how to accelerate bioprocess development and enhance manufacturing using hybrid modeling. Our guest, Michael Sokolov, COO of DataHow (a spin-off company from ETH Zurich), shares valuable insights.

Discover the three major takeaways that could transform the bioprocessing industry:

1. Unlocking the Power of Hybrid Modeling: Michael Sokolov introduces the revolutionary concept of hybrid modeling, which combines mechanistic knowledge with machine learning to expedite bioprocess development.

2. Accelerating Process Development: Learn how hybrid modeling can speed up your bioprocessing efforts, potentially allowing you to reduce the number of experiments by 60-80%, saving valuable time and resources.

3. Data-Driven Decision Making: Gain insights into how this approach enables data-driven decision making in the unpredictable world of biotech. It provides a deep understanding and empowers scientists to make informed choices.

Don't miss this episode for a comprehensive guide to smarter and more efficient bioprocessing!

Connect with Michael Sokolov:

Website: www.datahow.ch

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In the second part of our conversation with Michael Sokolov, the co-founder and COO of DataHow, we dive into practical insights on leveraging hybrid modeling in bioprocessing.

You will discover:

1. Starting Small, Dreaming Big: Even in smaller companies, you can start with a minimal number of reactors and still leverage hybrid modeling effectively. Whether it's just a few shakers or a handful of bioreactors, you can begin the journey to process improvement.

2. The Power of Digital Twins: Michael sheds light on the concept of digital twins, which involves creating a real-time model of your bioprocess. It not only helps optimize the process but also enables feedback control, reducing manual operations and adapting to changes on the fly.

3. Regulatory Acceptance: While the pharmaceutical industry is known for its conservatism, regulators are becoming more receptive to innovative technologies like hybrid modeling. Health authorities are encouraging the use of promising tools in process development and are not imposing specific technologies. As more companies adopt these tools and gather data on their effectiveness, they are likely to play a more prominent role in regulatory filings.

Don't miss out on this insightful discussion with Michael Sokolov as he unravels the potential of hybrid modeling in bioprocessing. If you're looking to simplify and streamline your bioprocessing journey, this episode is a must-listen.

Connect with Michael Sokolov:

Website: www.datahow.ch

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In this episode, we explore the world of adherent cell cultures with Payar Radfar, CEO of Smart MCs. Smart MCs specializes in customized biomaterials and microfluidic solutions. Payar shares his unique journey in the biotech industry, driven by his passion for improving people's health.

Key Takeaways:

1. Revolutionizing Bioprocessing: Payar discusses the challenges scientists face when transitioning from lab-scale to industrial-scale production. He emphasizes the importance of a multidisciplinary approach and envisions his company playing a crucial role in simplifying and enhancing bioprocessing technologies.

2. Cost Challenges in Cellular Therapies: Payar addresses the high costs associated with cellular therapies and explores the barriers to wider distribution. He highlights the role of competition and regulations in reducing costs and increasing accessibility to these therapies.

3. The Power of Microcarriers: The technical discussion focuses on microcarriers and their vital role in adherent cell cultures. Payar explains how these microscopic spheres enable efficient scaling up of cell production in bioreactors, offering a glimpse into the future of bioprocessing.

Are you curious about the transformative potential of microcarriers and the future of bioprocessing?

Join us in this insightful conversation with Payar Radfar as we uncover the secrets behind scaling up adherent cell cultures and their profound impact on the biotech industry.

Connect with Payar Radfar:

Website: https://smartmcs.com.au/

LinkedIn: linkedin.com/company/smart-mcs

Twitter: twitter.com/SmartMCsPTYLTD

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In the second part of our insightful interview with Payar Radfar, CEO of Smart MCs, we delve into the practical steps of developing adherence cell cultures for bioprocessing scalability.

Payar emphasizes the critical need for patience and a methodical approach, recounting how many clients rush into large-scale cultures prematurely. The key takeaways include:

1. Start Small, Stay Patient: Begin with small cultures and test various microcarriers. Patience is crucial; rushing can lead to ambiguous results and hinder long-term success.

2. Role of Modeling: Payar discusses the potential of AI modeling in scaling up processes. While AI can save time, he emphasizes the importance of a cautious, step-by-step approach.

3. Avoid Pitfalls: Highlighting the diverse nature of cell types, microcarriers, and bioreactors, Payar warns against assuming uniformity. Each component plays a crucial role, requiring careful consideration and gradual adjustments.

Join us as we explore future trends in bioprocessing, where Payar anticipates breakthroughs in media formulation and the use of novel technologies like microfluidics. Discover the broad applications beyond cellular therapies and cultivated meat, reaching into vaccine production and other cell-dependent fields.

Tune in now to gain invaluable insights into the dynamic world of adherence cell cultures and the promising future of bioprocessing innovation.

Connect with Payar Radfar:

Website: https://smartmcs.com.au/

LinkedIn: linkedin.com/company/smart-mcs

Twitter: twitter.com/SmartMCsPTYLTD

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In this episode, Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform, shares insights into revolutionizing cell-line development through nanopens and microenvironments.

Key Takeaways:

1. Challenging the Status Quo: Tanner challenges conventional thinking, highlighting the limitations of planar cell cultures and the shortcomings of traditional approaches in the field. His perspective sparks a conversation about the need for innovative thinking in bioprocess development.
2. The Multidisciplinary Nature of Cell-Line Development: Tanner emphasizes the importance of multidisciplinary collaboration in the industry. He stresses that success in bioprocess development requires not only scientific expertise but also effective communication and teamwork across diverse disciplines.
3. Critical Aspects for High Productivity Clones: The discussion explores the significance of microenvironments in cell-line development. Tanner introduces the concept of nanopens—tiny chambers that mimic bioreactor conditions, enabling precise screening and optimization for high productivity clones.

Join us as we uncover the dynamic intersection of science and engineering, challenging the norms in cell-line development.

Connect with Tanner Nevill:

LinkedIn: www.linkedin.com/in/tannernevill

Website: https://brukercellularanalysis.com/products/workflows/cell-line-development

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Unlock the secrets of cell-line development with Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform.

In this interview, Tanner delves into the transformative power of nanopens and microenvironments in cell-line development.

Key Takeaways:

1. Nanopens Redefining Norms: Tanner introduces the game-changing nanopens, disrupting traditional cell line development. Learn how these innovative tools are reshaping the landscape and ushering in a new era of efficiency.
2. AI's Impact on In Silico Discovery: Explore the future of cell-line development as Tanner discusses the integration of AI. Uncover how in silico discovery and engineering are poised to revolutionize processes, prompting a shift towards early functional testing and accelerated throughput.
3. Strategies for Small Players: Gain insights into practical strategies for smaller companies seeking to enhance throughput and reduce cell-line development durations. Tanner emphasizes the importance of understanding cost dynamics and leveraging data-driven decision-making.

Join us as Tanner Nevill navigates the dynamic intersection of technology and life sciences, offering a glimpse into the evolving landscape of cell-line development.

Connect with Tanner Nevill:

For more on Tanner's insights and the revolutionary Beacon Optofluidic Platform, connect with him on LinkedIn or search for "beacon, CLD or CLD beacon."

LinkedIn: www.linkedin.com/in/tannernevill

Website: https://brukercellularanalysis.com/products/workflows/cell-line-development

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Dive into the world of cell therapy process development with Steve Oh, former Institute Professor at the Bioprocessing Technology Institute (BTI) at the Agency for Science and Technology (A*STAR) and now Scientific Advisor to several international companies, as he shares thought-provoking perspectives and predictions on technologies that will impact the biotech industry.

In this riveting conversation, Steve Oh unveils secrets to consistent bioproducts and forecasts the future of cell and gene therapy.

Gain a deeper understanding of the evolving landscape and the challenges and opportunities it presents.

Key Takeaways:

1. The Power of Open Mindsets: Discover why carefully orchestrated listening ears lay the foundation for developing solutions in bioprocess development. Learn how avoiding predetermined views enhances the quality of conversations.
2. Beyond Short-Term Goals: Uncover the downside of short-term thinking and how prioritizing long-term improvements can lead to substantial productivity gains. Steve delves into the balance between meeting financial deliverables and achieving lasting advancements.
3. Process Development as a Pillar: Gain insights into why process development is a critical pillar in every biotech company's journey towards scaling. Steve emphasizes the significance of manufacturing consistent biological products and the need to educate scientists on the process's pivotal role.

Join the conversation as Steve Oh unfolds the intricate world of cell therapy process development, offering a roadmap from lab exploration to patient impact.

Currently, Steve is an Scientific Advisor to several international companies involved in lentivirus & AAV manufacturing, cryopreservation solutions, biodegradable/edible microcarriers, novel gene delivery methods, cultured meat and stem cell manufacturing.

Connect with Steve Oh:

LinkedIn: https://www.linkedin.com/in/steve-oh-4946261/

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Welcome back to the second part of our exclusive interview with Steve Oh, former Institute Professor at the Bioprocessing Technology Institute (BTI) at the Agency for Science and Technology (A*STAR) and now Scientific Advisor to several international companies.

In this episode, Steve dives deep into the challenges of manufacturing different cell types, sharing insights gained from his groundbreaking research. From preventing spontaneous differentiation to optimizing multi-stage processes, Steve unveils the complexities of mastering cell therapy development.

Key Takeaways:

• Controlled Differentiation: Learn how Steve tackled the challenge of directed differentiation in a dynamic environment, ensuring cells follow the desired path without spontaneous deviations.
• Scaling Up Strategies: Explore Steve's expertise in choosing the right culture conditions for cultivating various cell types at scale, emphasizing the importance of microcarriers and their impact on maintaining stable states.
• Harvesting and Preservation: Delve into the critical aspects of harvesting cells and preserving their functionality. Discover innovative enzyme-based harvesting methods and the evolving landscape of cryopreservation beyond traditional DMSO.

Join us as Steve shares invaluable insights into the intricate world of cell therapy, offering a roadmap for developers and industry leaders alike. Don't miss this episode packed with expertise and practical advice.

Currently, Steve is an Scientific Advisor to several international companies involved in lentivirus & AAV manufacturing, cryopreservation solutions, biodegradable/edible microcarriers, novel gene delivery methods, cultured meat and stem cell manufacturing.

Connect with Steve Oh:

LinkedIn: https://www.linkedin.com/in/steve-oh-4946261/

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Wondering how you can leverage the immense potential of the rapidly evolving world of digital transformation in biomanufacturing?

Join us as we explore the frontiers of technology and innovation with Abhijeet Satwekar, Innovation Manager at Merck Healthcare.

Discover how cutting-edge digital technologies are revolutionizing bioprocesses, optimizing efficiency, and ensuring consistent product quality.

Key Learnings:

1. Process Optimization: Discover the transformative impact of digital technologies on optimizing processes from small-scale studies to large-scale manufacturing, ensuring robustness and consistent product quality.
2. Digital Twin and Efficiency: Explore the realm of digital twins, simulations, and business intelligence tools that revolutionize batch scheduling, planning, and overall bio-manufacturing efficiency.
3. Balancing Innovation and Regulation: Understand the delicate balance between embracing new technologies and satisfying regulatory requirements. Abhijeet provides insights into maintaining confidence through a hybrid model that combines digital insights with traditional process analytical technology.

Tune in for a wealth of knowledge that transcends the boundaries of traditional and digital realms in the quest for groundbreaking biologics.

Connect with Abhijeet Satwekar:

LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar/

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Are you struggling to unlock the full potential of Process Analytical Technology (PAT) in biomanufacturing?

Look no further!

Join us for a game-changing conversation with Abhijeet Satwekar, an Innovation Manager at Merck Guidonia-Rome, Italy.

Discover how PAT can revolutionize your decision-making, accelerate development timelines, and propel your biotech company to new heights.

Key Learnings:

1. Decoding PAT's Impact: Abhijeet provides unprecedented insights into how PAT technologies revolutionize decision-making in real-time, ensuring unparalleled control over manufacturing processes. Discover the race towards achieving real-time release and initiatives propelling patient-centric value.
2. Fast-Tracking Development Timelines: Explore the potential of PAT in risk reduction by gaining step-by-step insights into process evolution. Uncover how comprehensive data capture can slash Quality Control testing lead times, potentially transforming weeks into mere days.
3. Mastering PAT Implementation Strategies: Abhijeet advocates for simplicity in adopting PAT, commencing with a strategic voice-of-customer approach. Delve into critical process points, select PAT tools judiciously, and establish equivalence with traditional methods for seamless integration.

Get ready to harness the power of PAT and gain a competitive edge in the digital transformation of biomanufacturing.

Don't miss out on this opportunity to become a PAT expert and unlock endless possibilities for success!

Connect with Abhijeet Satwekar:

LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar/

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Is bacon without pigs the future? In this episode, join us as Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, unveils the exciting possibilities.

Discover how he overcomes the challenges of production and envisions a future where cultivated steak competes on price. Beat Thalmann provides an insider's perspective on the complexities of cell lines and production processes, exploring the intersection of biopharmaceuticals and cultivated meat.

Explore the innovative techniques companies are adopting, from rethinking bioreactors to recycling media, in their quest to bring affordable and sustainable alternatives to our plates.

You will Learn:

1. Overcoming production challenges: Learn how you can tackle the hurdles in the development and scaling of cultivated meat production processes.
2. Innovative techniques: Discover the cutting-edge approaches being employed by companies in the field, such as reimagining bioreactors and adopting media recycling practices.
3. Strategies for Cost-Effective Scaling: Get a roadmap to achieving cost-effective processes, making cultivated meat a viable and affordable option for the future.

Tune in now to explore the future of bacon, steaks, and more – all without the need for traditional farming. It's a fascinating journey into the world of cultivated meat technology.

Connect with Beat Thalmann:

LinkedIn: https://www.linkedin.com/in/beatthalmann

Website: www.scinora.com

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In part 2, we explore the details of cost reduction in cultivated meat manufacturing, with a focus on two important factors: media and simplified bioreactors.

Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, highlights the strategic importance of selecting the right cells and advocates for a streamlined process that incorporates plant-based structures. This approach offers a cost-effective entry point for supermarkets.

Key Learnings:

• Discover the challenges of adapting adherent media for meat cells in suspension culture.
• Find out the most cost-effective approach that enables competitive pricing of cultivated meat products.
• Understand why the future of cultivated meat lies in niche products, which offer additional options alongside traditional meat and plant-based alternatives.

Don't miss this engaging conversation that unlocks the future of sustainable and innovative meat production.

Connect with Beat Thalmann:

LinkedIn: https://www.linkedin.com/in/beatthalmann

Website: www.scinora.com

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Join us as we unravel the complexities of computational methods in bioprocessing, featuring cutting-edge research on glycosylation and process development.

Ioscani Jiménez del Val, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, explores the intricacies of creating computational models, closing the loop, and optimizing with numerical methods.

Discover the two broad flavors of modeling – kinetic and metabolic models – and how they contribute to understanding cellular processes in bioreactors.

Key Learnings:

• Closed Loop Optimization: Learn how closing the computational loop enhances model robustness, generating experimental data to refine kinetic parameters.
• Modeling Variety: Explore different computational models, including kinetic models, metabolic models, and the rising trend of data-driven approaches for efficient bioprocess monitoring.
• Hybrid Modeling: Uncover the power of hybrid models, combining mechanistic and data-driven approaches for a comprehensive understanding of your production process.

Experience the journey of innovation as we explore how the revolutionary process of extracting valuable insights from your data is transforming the field of bioprocessing. Tune in now for an enlightening conversation with our esteemed expert guest.

Contact Ioscani Jiménez del Val:

Twitter: @UcdCell

LinkedIn: https://www.linkedin.com/in/ioscanij

Website: https://people.ucd.ie/ioscani.jimenezdelval

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In part 2 of this interview with Ioscani, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, we delve into the art and science of accelerating process development through the strategic extraction of valuable insights from data.

Our guest, a seasoned expert in computational modeling, unfolds the intricate dance between quality by design principles and data-driven approaches.

Key takeaways from this insightful conversation include:

• Optimizing with Confidence: Understand the input-output relationships qualitatively and quantitatively. Frame confidence spaces and align them with the design space for robust models.
• Strategic Experimentation: Uncover the fine line between modeling and experimental work. Learn how to use computational models to design optimally informative experiments, saving both time and resources.
• Balancing Act with Data: Navigate the delicate balance between adding value to model development programs and not overwhelming companies with excessive data demands.

Join us as we explore the transformative power of computational models in the biopharma sector, unlocking new possibilities for process optimization and efficiency.

Contact Ioscani Jiménez del Val:

Twitter: @UcdCell

LinkedIn: https://www.linkedin.com/in/ioscanij

Website: https://people.ucd.ie/ioscani.jimenezdelval

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• Consider Developability and Manufacturability: The success of your biotech asset hinges on developing a scalable process and ensuring cost-effective manufacturing. Assessing these aspects early guides strategic decision-making.
• Start Early: Bernardo stresses the need to consider crucial milestones from the moment you conceive a promising molecule. Avoid costly delays by initiating conversations with potential partners and service providers at the earliest stages.
• Find a Balance for Regulatory Aspects: While regulatory considerations are crucial, Bernardo advises against premature obsession. Prioritize good laboratory and manufacturing practices initially, saving detailed regulatory planning for later stages.

Website: www.drugbiologics.com/cdmoadvisor

Article: In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?: www.bioprocessonline.com/doc/in-search-of-the-unicorn-do-end-to-end-c-x-dmos-really-exist-0001

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Welcome to Part 2 of our conversation with Bernardo Estupiñán Gaisbauer, Principal at Drug Biologics Consulting.

In this insightful episode, we dive into the complex world of taking a molecule from the lab to clinical trials. Our guest shares invaluable insights into outsourcing strategies for biotech companies.

Key Learnings:

• Strategic Outsourcing: Discover when and why outsourcing is crucial for biotech companies, particularly in areas like analytical work and process development. Learn how it can be a game-changer for companies of all sizes.
• Critical Outsourcing Steps: Understand the pivotal role of analytics in confirming lab results and ensuring a robust process. Explore the importance of choosing the right outsourcing partner for scalability, from small bioreactors to larger manufacturing stages.
• Balancing Control and Expertise: Uncover the delicate balance between keeping in-house control and leveraging the expertise of outsourcing partners. Gain insights into finding the sweet spot to achieve process understanding and cost efficiency.

Join us for a deep dive into the outsourcing landscape, unraveling the intricacies of selecting the right partner and ensuring a successful collaboration. Tune in and elevate your biotech game!

Connect with Bernardo Estupiñán Gaisbauer:

Website: www.drugbiologics.com/cdmoadvisor

Article: In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?: www.bioprocessonline.com/doc/in-search-of-the-unicorn-do-end-to-end-c-x-dmos-really-exist-0001

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Are the escalating costs and intricate technical hurdles of cell therapy development causing you stress?

Tune into this insightful podcast episode featuring Shin Kawamata, CEO of Cyto-Facto Inc. in Kobe, Japan, who shares his expertise and innovative solutions to these pressing issues in the cell therapy industry.

Discover how to streamline your manufacturing processes, reduce costs, and enhance product quality, transforming the way you approach cell therapy development.

Key Takeaways:

1. Revolutionize Cell Manufacturing: Shin outlines how Cyto-Facto is pioneering a new business model, merging public sector support with commercial viability. Learn how this shift can accelerate the growth of the cell therapy industry.
2. Leverage QbD in Living Systems: Discover why Quality by Design (QbD) strategies are imperative for cell therapy manufacturing.
3. Scale Up Efficiently: Shin shares valuable insights on the challenges in scaling up cell therapies and the importance of automation, digitalization, and QbD in streamlining manufacturing processes, reducing costs, and enhancing product quality.

Join us as we uncover the latest advancements, challenges, and Shin's vision for the future of the cell therapy industry.

Connect with Shin:

• LinkedIn: www.linkedin.com/in/shin-kawamata-84647579
• Website: www.cytofacto.com/eng

Get Cell and Gene Therapy Training:

• Shin Kawamata's offer: The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory: https://www.isctglobal.org/resources/training-programs/workforce-development-in-biomanufacturing401/workforce-development-in-biomanufacturing
• Learn more about the upcoming Cell and Gene Therapy Training program for the Asia Pacific region: contact David at hello@bruehlmann-consulting.com

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Are you looking for advanced strategies to enhance the quality and efficiency of cell therapy manufacturing processes?

In this episode with Shin Kawamata, CEO of Cyto-Facto Inc., we dive into the transformative power of digitization in cell therapy manufacturing and explore strategies to enhance efficiency and reduce costs.

Actionable Takeaways:

1. Initiate Digital Transformation: Take the first step toward transforming your manufacturing processes by incorporating robust data business practices, ensuring a maturation of the cell therapy industry.
2. Leverage AI and Metabolome Sensors: Discover actionable insights into harnessing the power of AI for navigating cell therapy complexities. Implement metabolome sensors to actively monitor cell culture, gathering essential data for quality control and elevating your therapy development strategies.
3. Cultivate Collaborative Ecosystems: Shin shares practical insights into building comprehensive ecosystems and collaborating with various stakeholders.

Join us as we uncover the latest advancements, challenges, and Shin's vision for the future of the cell therapy industry.

Connect with Shin:

• LinkedIn: www.linkedin.com/in/shin-kawamata-84647579
• Website: www.cytofacto.com/eng

Get Cell and Gene Therapy Training:

• Shin Kawamata's offer: The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory: https://www.isctglobal.org/resources/training-programs/workforce-development-in-biomanufacturing401/workforce-development-in-biomanufacturing
• Learn more about the upcoming Cell and Gene Therapy Training program for the Asia Pacific region: contact David at hello@bruehlmann-consulting.com

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Embark on a journey into the intricate world of CMC development with our latest episode, unraveling the challenges that often baffle biotech scientists. The complexity of CMC development is a formidable hurdle, and in this insightful discussion, we delve into strategies to master this critical process.

Key Takeaways:

1. Start Early: Learn how starting CMC development early, even without a complete understanding of your drug, can reduce risks and prepare you better for clinical milestones.
2. Collaborate: CMC development should not work in isolation but integrate insights from diverse teams for a comprehensive drug development strategy.
3. Adopt a Platform Approach: Understand the role of platform processes in speeding up drug development and how they facilitate multiple attempts for cost-efficient progression from discovery to clinical trials, particularly in biologics.

Your journey to mastering CMC development starts here.

Connect with Gene Lee:

LinkedIn: www.linkedin.com/in/gene-w-lee-phd-0318b83

Website: www.altrubio.com

Next Step:

Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.com

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If you've ever wondered how to seamlessly transition from R&D to process development, this is your golden ticket. Uncover practical strategies and expert advice that can be your compass through the intricate landscape of mastering CMC development.

Uncover the challenges and tactics to seamlessly navigate this critical phase.

1. Conduct Early Developability Assessments: By assessing productivity, aggregation propensity, and manufacturability early on, you can strategically avoid future roadblocks.
2. Use a Platform: A platform approach facilitates swift and cost-effective transitions to clinical trials, reducing pre-proof of concept investment.
3. Bridge the R&D and Process Development Gap: Navigating this intricate phase successfully leads to seamless collaboration, promoting a unified approach and shared understanding among team members.

Connect with Gene Lee:

LinkedIn: www.linkedin.com/in/gene-w-lee-phd-0318b83

Website: www.altrubio.com

Next Step:

Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.com

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In this enlightening episode of the Smart Biotech Scientist podcast, we delve into the complex world of biotech scale-ups. We break down the 9 crucial steps to ensure a seamless transition from lab to large-scale production.

Top 3 Takeaways:

• Gain Comprehensive Process Understanding: Enhance your decision-making and problem-solving abilities by thoroughly understanding your process, molecule, and available expertise.
• Bridge the Technology Gaps: Overcome challenges and increase efficiency by leveraging suitable technology and strategic risk mitigation methodologies.
• Create a Clear, Step-by-Step Roadmap: Reduce confusion and facilitate a smooth scale-up process with a clear, detailed roadmap.

You will be armed with the knowledge to not just survive tech transfers, but to thrive.

Turn the tech transfer chaos into a well-orchestrated symphony with our expert insights!

Next Step:

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In this riveting episode of the Smart Biotech Scientist podcast, we navigate the intricate labyrinth of biotech scale-ups. We distill the process down to 9 essential steps for a smooth transition from laboratory to large-scale production.

Key Insights:

• Acquire Comprehensive Process Understanding: Bolster your decision-making and problem-solving skills with an in-depth understanding of your process, molecule, and expertise at your disposal.
• Span the Technology Gaps: Tackle obstacles and boost efficiency by utilizing appropriate technology and strategic risk mitigation techniques.
• Develop a Detailed, Sequential Roadmap: Alleviate confusion and ensure a fluid scale-up process with a precise, well-defined roadmap.

Equip yourself with the knowledge to not just endure tech transfers, but to excel.

Transform the tumult of tech transfer into a harmonious symphony with our expert guidance!

Next Step:

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Bioprocess development and scale-up are complex. Science may give you headaches, but biotech project management should not.

In this riveting episode, you'll learn how to simplify your CMC development, guiding you through the maze of project planning and execution.

Key Takeaways:

1. Uncover how to "Plan for Success," ensuring your projects are well-structured, resource-efficient, and delivered on time.
2. Learn the importance of "Evaluating the Scalability Potential," and why it's crucial for the long-term success of your project.
3. Discover the power of "Building a High-Performing Team," and how the right leadership can empower your team and skyrocket results.

Don't let complexity hold you back - tune in for these insights and more!

Next Step:

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Tackling bioprocess development and scale-up can be complex. While the science might be challenging, project management within biotech doesn't have to be.

In this engaging episode, we'll guide you on how to streamline your CMC development, demystifying the complexities of project planning and execution.

Here's what you'll gain:

1. Discover the secret to 'Successful Planning,' - a strategy to ensure your projects are well-organised, resource-smart, and timely delivered.
2. Understand the crucial role of 'Assessing Scalability Potential,' and why it's a game-changer for your project's long-term success.
3. Unleash the 'Power of a High-Performance Team,' and learn how effective leadership can enable your team to excel and achieve outstanding results.

Don't allow complexity to impede your progress - join us for these insights and beyond!

Next Step:

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In this enlightening episode, we're joined by Neil Templeton, Director in Upstream Process Development at Solid Biosciences, who pulls back the curtain on the intricate world of bioprocess development and manufacturing.

Neil delves into the shifting paradigms of the industry, sharing his expert insights on overcoming the unique challenges that surface when transitioning from R&D to GMP production. This episode is packed full of invaluable knowledge that's crucial for anyone looking to succeed in this field.

Key points we discuss include:

1. Strategies and solutions for overcoming the obstacles faced when transitioning from R&D to GMP production.
2. The importance and application of Design of Experiment (DOE) approaches, and their role in understanding critical process parameters.
3. The role of metabolite analysis in optimizing processes and ensuring their robustness.

Get connected with Neil Templeton:

LinkedIn: https://www.linkedin.com/in/neil-templeton

Next Step:

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In our insightful second part of the conversation, we broaden our perspective to delve into the various modalities within the biotech industry, highlighting the unique and shared aspects of process development and scale-up.

Neil Templeton, the Director of Upstream Process Development at Solid Biosciences, passionately articulates his commitment towards making gene therapy more accessible. He does this by outlining strategic solutions to reduce the costs of development and manufacturing.

You will gain:

1. A comprehensive understanding of process development's similarities and differences across biologics, vaccines, and cell and gene therapy manufacturing.
2. Effective strategies aimed at reducing the costs associated with gene therapy development and manufacturing.
3. Insights into how capitalizing on the expertise from the biologics sector can positively impact other fields.

To connect with Neil Templeton and learn more about his work, visit his LinkedIn profile.

LinkedIn: https://www.linkedin.com/in/neil-templeton

Next Step:

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Get ready for a crash course in glycoengineering as Thomas Rexer, CTO of eversyn, a spin-off of the Max Planck Institute Magdeburg, breaks down the significance of modifying glycans in biopharmaceuticals.

Explore the science behind glycoengineering and its potential to enhance the properties of therapeutic proteins.

Key Insights:

1. Unlock new frontiers in glycoengineering
2. Explore the potential of glycoengineering to revolutionize biopharmaceuticals
3. Ensure seamless integration of glycoengineering into production processes

Don't miss this episode as Thomas unveils the trends that will shape the future of glycoengineering, offering actionable insights for scientists, entrepreneurs, and biotech enthusiasts alike.

Connect with Thomas Rexer:

LinkedIn: https://www.linkedin.com/in/thomas-rexer

Website: www.eversyn.de

Next Step:

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Discover the hurdles and breakthroughs in glycoengineering, including the high costs of activated sugars.

Thomas Rexer, CTO of eversyn, a spin-off of the Max Planck Institute Magdeburg, unveils eversyn's multi-step biocatalysis process, designed to significantly drive down costs and make in vitro glycoengineering more accessible on a large scale.

Key Insights:

1. Uncover the power of multistep biocatalysis in driving down costs and making in vitro glycoengineering more accessible.
2. Bridge the Gap between academia and industry in glycoengineering and thus ensure a smoother integration of groundbreaking glycoengineering technologies into the industrial landscape.
3. Gain valuable insights into the challenges and triumphs of transitioning from pure science to entrepreneurship, offering aspiring scientists a roadmap to navigate the unknown.

Connect with Thomas Rexer:

LinkedIn: https://www.linkedin.com/in/thomas-rexer

Website: www.eversyn.de

Next Step:

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Uncover the secrets of successful innovators, including Steve Jobs, Elon Musk, and Thomas Edison, in this enlightening episode of our podcast. We dive deep into the habits that set these trailblazers apart and fuel their innovative spirit.

Key learnings include:

1. The power of curiosity and how it leads to groundbreaking ideas and improvements.
2. The importance of connecting the dots to gain new insights and see invisible relationships.
3. The role of risk-taking in pushing boundaries and experimenting with new ideas.

These insights provide a roadmap to developing your own innovative mindset and achieving success. Don't miss out on these valuable insights that could ignite your innovative spirit. Tune in now!

Next Step:

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Uncover the secrets of successful innovators, including Steve Jobs, Elon Musk, and Thomas Edison, in this enlightening episode of our podcast. We dive deep into the habits that set these trailblazers apart and fuel their innovative spirit.

Key learnings include:

1. The power of curiosity and how it leads to groundbreaking ideas and improvements.
2. The importance of connecting the dots to gain new insights and see invisible relationships.
3. The role of risk-taking in pushing boundaries and experimenting with new ideas.

These insights provide a roadmap to developing your own innovative mindset and achieving success. Don't miss out on these valuable insights that could ignite your innovative spirit. Tune in now!

Next Step:

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Get ready for a deep dive into the world of bioprocess development as Joel Eichmann, Managing Director of Green Elephant Biotech, shares his expertise on smart strategies for adherent cell culture .

Join us as we unravel the intricacies of adherent cell culture and discover the innovative strategies shaping the future of bioprocess development.

You’ll get:

1. Acquire a comprehensive understanding of the key challenges in developing an adherent cell culture process.
2. Gain a fresh perspective on the role of microcarriers and explore alternative options for adherent cell cultures.
3. Uncover the unique inspiration behind Joel's bioreactor for adherent cells and how childhood experiences can spark groundbreaking ideas.

Join us for an insightful conversation and invaluable insights for biotech professionals, researchers, and enthusiasts like you looking to navigate the complexities of adherent cell culture and bioprocess development.

Contact Joel Eichmann:

LinkedIn: https://www.linkedin.com/in/joel-eichmann

Website: https://www.greenelephantbiotech.com

Next Step:

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Welcome back to the second part of our insightful interview with Joel Eichmann, Managing Director of Green Elephant Biotech.

In this episode, we delve deeper into the technical aspects of adherent cell expansion systems, explore sustainable biotech practices, and discuss key considerations for cost-efficient and environmentally friendly bioprocessing.

Key Insights:

• How to adopt a strategic approach to adherent cell culture development
• Delve into the intricacies of scaling up adherent cell culture, understanding the challenges associated with transitioning from T-flasks to larger, dynamic environments
• Discover sustainable biotech practices to reducing your carbon footprint

Whether you're a seasoned professional or a curious enthusiast, this episode provides a wealth of knowledge for those passionate about advancing biotech process develoment.

Contact Joel Eichmann:

LinkedIn: https://www.linkedin.com/in/joel-eichmann

Website: https://www.greenelephantbiotech.com

Next Step:

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Explore perfusion processes and sustainability with our guest, Jochen Sieck, Director of Cell Culture Media and Process Development at Merck Life Science.

Learn about the evolution of perfusion methodologies, its historical roots in addressing product stability, and its recent return to continuous and integrated manufacturing.

Jochen discusses the economic and strategic reasons behind perfusion's resurgence, emphasizing the need for flexible, smaller-scale facilities.

Key Learnings:

1. Gain insight into the environmental impact of traditional facilities and the potential benefits of alternatives.
2. Dive deep into the balance of cost, productivity, and sustainability in media consumption.
3. Discover strategies for optimizing perfusion rates and sustainability.

Get ready to expand your understanding of perfusion processes, sustainability, and the delicate dance between economics and environmental consciousness.

Connect with Jochen Sieck:

LinkedIn: https://www.linkedin.com/in/jochenbsieck

ACTIP Fellowship award: https://www.actip.org/fellowship

Resources:

Perfusion Cell Culture Processes for Biopharmaceuticals by Moritz Wolf, Jean-Marc Bielser, and Massimo Morbidelli: https://www.cambridge.org/core/books/perfusion-cell-culture-processes-for-biopharmaceuticals/5C650AD26D52B2435E7796D382ECE5DA

Next Step:

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Explore the intricate world of perfusion and its sustainability challenges in the part 2 of this episode. Dive into the operational side of managing vast quantities of media production and storage, and discover smart strategies to address these challenges.

Jochen Sieck, Director of Cell Culture Media and Process Development at Merck Life Science, discusses the distinction between facility designs for batch and perfusion bioreactors, shedding light on the need for extensive tank farms to support perfusion.

Key Insights:

1. Explore the success of automated perfusion media preparation at the lab scale and its scaling up to a 500L capacity.
2. Discover how advancements in small-scale perfusion operations are supercharging the perfusion process development.
3. Get practical steps for developing a cost-efficient perfusion process.

Tune in to discover how perfusion processes are revolutionizing the biotech industry and contributing to a more sustainable future.

Connect with Jochen Sieck:

LinkedIn: https://www.linkedin.com/in/jochenbsieck

ACTIP Fellowship award: https://www.actip.org/fellowship

Resources:

Perfusion Cell Culture Processes for Biopharmaceuticals by Moritz Wolf, Jean-Marc Bielser, and Massimo Morbidelli: https://www.cambridge.org/core/books/perfusion-cell-culture-processes-for-biopharmaceuticals/5C650AD26D52B2435E7796D382ECE5DA

Next Step:

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In this episode, Wei Zhang, DSP Group Head at A*STAR Bioprocessing Technology Institute, delves into the complexities of purification. Wei’s team pioneers bioprocessing processes for diverse biotherapeutics.

You will gain valuable insights into the intricate challenges and innovative solutions in bioprocessing purification.

You will learn:

1. Master scale-up challenges
2. Understand how you can ensure product stability
3. Get an overview of the advancements in purification techniques

The conversation unravels the evolving landscape of bioprocessing, where the emergence of complex drug modalities necessitates continuous advancements in purification techniques and tools.

Connect with Wei Zhang:

LinkedIn: https://www.linkedin.com/in/wei-zhang-a6539845

Next Step:

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In part 2 of this insightful episode, we embark on a journey into the intricate world of biotech purification processes. Our guest, Wei Zhang, DSP Group Head at A*STAR Bioprocessing Technology Institute, delves into three key modalities, shedding light on the challenges and advancements in virus, RNA, and traditional vaccine purification.

You will learn:

1. Learn how to master the purification of viruses
2. Get an overview of the advancements in RNA purification techniques: the evolution from simple RNA structures to long-stranded messenger RNA (mRNA)
3. How to improve separation efficiency and simplify scale-up to meet increasing demands

Tune in as we unravel the complexities of downstream processing and glean valuable insights to excel in the dynamic field of bioprocessing purification.

Connect with Wei Zhang:

LinkedIn: https://www.linkedin.com/in/wei-zhang-a6539845

Next Step:

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Hey, fellow scientists! Do you find yourself buried under an avalanche of tasks, unsure which one truly matters? If you're tired of the chaos and want to reclaim control of your time and energy, stick around.

Today, we're unlocking the secrets of Essentialism, tailor-made for busy biotech scientists like you. We discuss the importance of focusing on the vital few tasks that contribute significantly to your goals, celebrating small wins, and protecting your time.

We also share a powerful story that illustrates the potential of Essentialism. Discover how Essentialism is not about doing more, but doing the right things, and how this disciplined approach can lead you to significant breakthroughs in your bioprocess CMC development activities. This episode is a must-listen for any scientist and engineer who feels overcommitted, overloaded, or overworked.

Tune in to learn how to navigate the complex world of biotech process development in a more strategic, efficient, and successful way.

Next Step:

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Hey, fellow scientists! Do you find yourself buried under an avalanche of tasks, unsure which one truly matters? If you're tired of the chaos and want to reclaim control of your time and energy, stick around.

Today, we're unlocking the secrets of Essentialism, tailor-made for busy biotech scientists like you. We discuss the importance of focusing on the vital few tasks that contribute significantly to your goals, celebrating small wins, and protecting your time.

We also share a powerful story that illustrates the potential of Essentialism. Discover how Essentialism is not about doing more, but doing the right things, and how this disciplined approach can lead you to significant breakthroughs in your bioprocess CMC development activities. This episode is a must-listen for any scientist and engineer who feels overcommitted, overloaded, or overworked.

Tune in to learn how to navigate the complex world of biotech process development in a more strategic, efficient, and successful way.

Next Step:

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Does unlocking the secrets of glycan engineering seem like navigating a labyrinth of molecular complexity?

In this episode, we delve into the pivotal role of glycans as critical quality attributes (CQAs) in biotherapeutics.

Henning von Horsten, Professor of Industrial Bioengineering at HTW Berlin (University of Applied Sciences in Berlin), sheds light on the art and science of glycan engineering and analysis.

Key highlights:

1. Discover various methods scientists are utilizing to improve glycan profiles.
2. Get insights into the challenges and solutions of off-target effects and cellular metabolic adjustments.
3. Learn about the exciting advancements in synthesizing ideal glycans outside living cells.

Connect with Henning von Horsten:

• LinkedIn: https://www.linkedin.com/in/henning-von-horsten-b259102/
• Website: https://lsm.htw-berlin.de/team/prof-dr-rer-nat-hans-henning-von-horsten/

Next Step:

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Does uncovering the secrets of glycan engineering feel like navigating a maze of molecular complexity?

In this captivating continuation of our exploration into the world of glycan engineering, we delve deeper into groundbreaking innovations and the crucial role of analytics in ensuring consistent quality.

Henning von Horsten, Professor of Industrial Bioengineering at HTW Berlin (University of Applied Sciences in Berlin), shares the fascinating story behind a groundbreaking technology designed to modulate antibody-dependent cell-mediated cytotoxicity (ADCC).

You’ll get:

1. Learn how advancements in high-throughput techniques are streamlining analytics for quicker insights and data-driven optimizations.
2. Explore the future of glycan engineering, which may lead to more effective therapeutics.
3. Understand why glycans matter across various fields of biotechnology, including monoclonal antibodies and vaccines, and discover their pivotal role in shaping the future of healthcare.

Connect with Henning von Horsten:

• LinkedIn: https://www.linkedin.com/in/henning-von-horsten-b259102/
• Website: https://lsm.htw-berlin.de/team/prof-dr-rer-nat-hans-henning-von-horsten/

Next Step:

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Dive into the fascinating world of cultivated meat with our guest, Petra Hanga, Lecturer in Biochemical Engineering – Cellular Agriculture at University College London and the Chief Scientific Officer of Quest Meat Ltd.

In this episode, Petra sheds light on the intricacies of developing cultivated meat and reveals the key hurdles biotech scientists face.

Highlights:

1. Learn how scientists tackle the complexity of replicating animal meat, ensuring a truly authentic taste and texture for future meat alternatives.
2. Gain insight into the innovative solutions shaping the future of sustainable protein sources.
3. Discover the potential of cultivated meat to revolutionize our food system.

Join us as we explore the promising landscape of cultivated meat, where science and innovation converge to shape a more sustainable future.

Enjoy your listening!

Connect with Petra Hanga:

LinkedIn: https://www.linkedin.com/in/petrahanga/

Twitter: @PetraHanga

Next Step:

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Dive into the future of food with our latest episode, "From Lab to Table: The Science Behind Cultivated Meat." With our guest, Petra Hanga, a Lecturer in Biochemical Engineering at University College London and Chief Scientific Officer of Quest Meat Ltd., we unravel the secrets behind this groundbreaking technology.

Key highlights:

1. Discover how stem cells revolutionize the production of cultivated meat, providing a scalable solution for creating muscle, fat, and connective tissues.

2. Explore the intricate balance of nutrients, growth factors, and environmental conditions crucial for maximizing cell growth and quality.

3. Understand the challenges and breakthroughs in scaling up bioreactor processes for efficient meat production.

Join us for an informative discussion on the cutting edge of food technology. Gain valuable insights into the process of transforming lab-grown cells into delectable dishes on your table.

Don't miss out on this compelling episode!

Connect with Petra Hanga:

LinkedIn: https://www.linkedin.com/in/petrahanga/

Twitter: @PetraHanga

Next Step:

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Join us in this enlightening episode as we explore process economics with industry expert Brian Kelley. He is the Senior Vice President of Process Development at VIR Biotechnology.

Unraveling the mysteries of cost management in antibody therapeutics, Brian sheds light on the intricate challenges faced by biotech scientists and engineers.

Key Highlights:

1. Discover the nuanced interplay between technical and cultural obstacles in process development.
2. Navigate the labyrinth of cost drivers in antibody manufacturing, from raw materials to labor expenses.
3. Learn the art of balancing speed, quality, and cost-effectiveness in bringing therapeutics to market.

Tune in for a masterclass in maximizing efficiency and driving down costs in the dynamic landscape of biologics production.

Connect with Brian Kelley:

LinkedIn: https://www.linkedin.com/in/brian-kelley-3389375

Next Step:

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Unlock the secrets to cost-efficient antibody therapeutics with Brian Kelley, Senior Vice President of Process Development at VIR Biotechnology.

In this illuminating episode, industry expert Brian Kelley shares invaluable insights into driving down manufacturing costs while maintaining quality and accessibility. From optimizing batch sizes to maximizing titers, discover practical strategies to streamline the process economics of antibody development.

Key Takeaways:

1. Scale Matters: Learn how economies of scale play a pivotal role in minimizing manufacturing costs, paving the way for global accessibility of life-saving therapies.
2. Titer Triumphs: Dive deep into the significance of maximizing titers to achieve substantial reductions in batch requirements and cost of goods, revolutionizing antibody production efficiency.
3. Focus Innovation: Gain clarity on where to direct innovation efforts, balancing established manufacturing practices with groundbreaking developments in emerging modalities like cell and gene therapies.

Join us as we unravel the future landscape of antibody production, where simplicity and innovation converge to shape the next frontier of healthcare solutions. Tune in now for actionable strategies and visionary perspectives on mastering process economics in antibody therapeutics.

Connect with Brian Kelley:

LinkedIn: https://www.linkedin.com/in/brian-kelley-3389375

Next Step:

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In this episode, we embark on a journey to uncover the essential strategies for navigating stakeholder relationships in bioprocess CMC development projects.

We delve into the critical role of stakeholders in bioprocess development and how their engagement can determine the success or failure of a project. Drawing from real-life experiences and insights, we explore the importance of understanding stakeholder needs, interests, and power dynamics.

Discover why stakeholder management is not just a skill but an art form essential for unlocking bioprocess success. Join us as we unravel the complexities of stakeholder engagement and provide actionable tips for mastering this crucial aspect of bioprocess development.

Tune in to learn how decoding the dynamics of stakeholder management can lead to triumph in bioprocess projects.

Next Step:

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In the second part of "Decode Bioprocess Success: The Art of Stakeholder Management," we delve deeper into the strategies for effective stakeholder management in bioprocess development.

Through a step-by-step approach, we explore how to identify, classify, and engage with stakeholders to ensure project success.

Key highlights:

1. Learn how to create a stakeholder management plan tailored to the unique needs and interests of each stakeholder group.
2. Discover the power interest grid, a valuable tool for categorizing stakeholders based on their level of influence and interest in the project.
3. Gain insights into developing communication plans that align with stakeholders' preferences and needs.

Join us as we uncover the art of stakeholder management and its transformative impact on bioprocess development success. Don't miss out on this episode filled with practical advice and actionable strategies for mastering stakeholder engagement in bioprocess projects.

Next Step:

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Are you finding the path to commercializing cell and gene therapies complex and uncertain?

Join us as we explore this intricate landscape with our guest, Wajiha Ali. As a strategy expert who believes in bridging the gap between research and commericalization with data who she will guide us through the challenges, victories, and vital strategies for successfully bringing these cutting-edge therapies to market.

Key Highlights:

1. Discover the amplified complexity of cell and gene therapies, from patient referral hurdles to manufacturing site regulations.
2. Explore the crucial commercialization strategies, infrastructure requirements, and the delicate balance between innovation and necessity.
3. Unveil the regulatory scrutiny and stakeholder management intricacies, paving the way for safer, more accessible therapies.

Tune in as we navigate the journey from scientific breakthroughs to real-world application, unraveling the complexities shaping the future of healthcare.

Connect with Wajiha Ali:

LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454

X (Twitter): https://twitter.com/Wajihaali

Next Step:

Develop biologics and cell & gene therapies with peace of mind. Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Does the process of commercializing cell and gene therapies seem complex and unclear to you?

Dive deep into the groundbreaking world of cell and gene therapies with our guest, Wajiha Ali, a strategy expert who believes in bridging the gap between research and commercialization with data, as we unravel the complexities of bringing life-saving therapies to patients.

From cutting-edge technologies to innovative collaboration models, we explore the future landscape of these transformative treatments.

You’ll get:

1. An understanding of how partnerships between academic centers, pharma companies, and regulators can decrease development costs and simplify commercialization, resulting in wider accessibility.
2. An investigation into how data analytics, AI, and machine learning can transform supply chains, target selection, commercialization strategies, and regulatory frameworks.
3. A discovery of new methods for equitable therapy access, such as outcome-based pricing, local manufacturing, and the growing role of digital platforms in patient advocacy.

Join us on this insightful journey into the future of cell and gene therapies.

Connect with Wajiha Ali:

LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454

X (Twitter): https://twitter.com/Wajihaali

Next Step:

Develop biologics and cell & gene therapies with peace of mind. Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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How can you provide stress-free cultivation conditions to achieve higher cell concentrations and quality? In a nutshell, bionic bioreactors and thus change bubble-free gas exchange change the game.

Join us as we delve into the future of biotech with our guest, Patrick Bongartz, CEO of BioThrust and an expert in innovative bioreactor design.

Key Highlights:

1. Unveil the groundbreaking "artificial lung," a marvel of engineering that decouples mixing and gas transfer, enabling stress-free cell growth at unprecedented densities.
2. From scaling issues to cell sensitivity, discover the hurdles that demand ingenious solutions.
3. Explore the critical factors when handling sensitive cell types driving bioreactor evolution.

Discover how bionic bioreactors are paving the way for a stress-free future in cell cultivation.

Connect with Patrick Bongartz:

Website: https://biothrust.de

Linkedin BioThrust https://www.linkedin.com/company/biothrust-de

Instagram: https://www.instagram.com/biothrust

Patrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/

Next Step:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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How can you create an environment suitable for shear-stress-sensitive cells that results in higher cell concentrations and superior quality? Essentially, bionic bioreactors revolutionize this process, changing the game rules with their ability to facilitate bubble-free gas exchange.

Join us in this episode as we unravel the groundbreaking innovations in bioreactor technology with our guest, Patrick Bongartz, CEO of BioThrust and the visionary mind behind stress-free cell cultivation.

Key Highlights:

1. Discover how bionic bioreactors defy conventional limitations, doubling cell densities even in sensitive cultures like insect cells, promising a paradigm shift in bioproduction efficiency.
2. Unveil the game-changing membrane stirrer technology that not only enhances oxygen transfer but also facilitates precise pH control, revolutionizing process optimization and scalability.
3. Embrace the challenge of disrupting conservative mindsets in the biotech industry.

Embark on a journey of scientific breakthroughs and entrepreneurial resilience in this episode.

Connect with Patrick Bongartz:

Website: https://biothrust.de

Linkedin BioThrust https://www.linkedin.com/company/biothrust-de

Instagram: https://www.instagram.com/biothrust

Patrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/

Next Step:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Send us a text

How can you create an environment suitable for shear-stress-sensitive cells that results in higher cell concentrations and superior quality? Essentially, bionic bioreactors revolutionize this process, changing the game rules with their ability to facilitate bubble-free gas exchange.

Join us in this episode as we unravel the groundbreaking innovations in bioreactor technology with our guest, Patrick Bongartz, CEO of BioThrust and the visionary mind behind stress-free cell cultivation.

Key Highlights:

1. Discover how bionic bioreactors defy conventional limitations, doubling cell densities even in sensitive cultures like insect cells, promising a paradigm shift in bioproduction efficiency.
2. Unveil the game-changing membrane stirrer technology that not only enhances oxygen transfer but also facilitates precise pH control, revolutionizing process optimization and scalability.
3. Embrace the challenge of disrupting conservative mindsets in the biotech industry.

Embark on a journey of scientific breakthroughs and entrepreneurial resilience in this episode.

Connect with Patrick Bongartz:

Website: https://biothrust.de

Linkedin BioThrust: https://www.linkedin.com/company/biothrust-de

Instagram: https://www.instagram.com/biothrust

Patrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/

Next Step:

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Is cultivated meat the food of tomorrow or just a passing trend? In this episode, we dive deep with Steven Lang, an expert in the field of cultivated meat. Steven sheds light on the intricate process of creating meat in the lab, the challenges faced, and the potential future of this innovative industry.

Key Takeaways:

1. Precision in Analytics: Discover how cutting-edge sensory analytics are crucial for developing cultivated meat that mimics traditional meat's texture and taste.
2. Regulatory Innovation: Learn why the regulatory landscape for cultivated meat is set to revolutionize, benefiting not just food tech but also the biopharmaceutical industry.
3. Future Prospects: Understand the potential pitfalls and the exciting innovations on the horizon, making cultivated meat a game-changer for food and biotech sectors.

Tune in to explore whether cultivated meat is the future we’ve been waiting for or just a bubble waiting to burst.

Connect with Steven Lang:

LinkedIn: https://www.linkedin.com/in/steven-lang-b003406

Next Step:

Don't miss out on boosting your bioprocess development strategy! Schedule your complimentary assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Join us for an insightful episode as we dive into the world of bioprocess CMC development strategies with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.

Matthias shares his wealth of knowledge on avoiding common pitfalls in developing robust Chemistry, Manufacturing, and Controls (CMC) strategies. He also emphasizes the critical elements that ensure your biotech product's success.

Key Takeaways:

1. Start Strong: Establishing a comprehensive CMC plan early can prevent costly and time-consuming issues later.
2. Leverage Expertise: Bringing in external CMC consultants early on can bridge knowledge gaps and streamline the development process.
3. Build Internally: Gradually develop in-house CMC capabilities to enhance long-term project viability and attract investor confidence.

Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.

Connect with Matthias Müllner:

LinkedIn: https://www.linkedin.com/in/matthias-muellner

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.

Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.

Key Takeaways:

1. Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring product consistency—a game-changer in the industry's quest for reliability.
2. By adopting a phased approach to process development rooted in QbD, companies can streamline experimentation, minimize resource expenditure, and accelerate time-to-market, amplifying efficiency by up to 40%.
3. Embracing innovation, such as machine learning and digitalization, holds the key to unlocking new horizons in CMC development, paving the way for a future where creativity and regulatory compliance converge seamlessly.

Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.

Connect with Matthias Müllner:

LinkedIn: https://www.linkedin.com/in/matthias-muellner

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Curious about the latest advancements in next-generation sequencing (NGS) and how they are revolutionizing science and medicine?

In this episode, we delve into the cutting-edge developments of NGS with our expert guest, Jonathon Hill, VP of Science and Technology and a co-founder of Wasatch BioLabs and Associate Professor of Cell Biology and Physiology at Brigham Young University, who has been at the forefront of this transformative field.

Key Takeaways:

1. Discover how NGS is empowering scientists to explore new frontiers in research with groundbreaking tools and technologies.
2. Learn about the incredible advancements in long-read sequencing and their impact on genome assembly and understanding complex diseases.
3. Understand how NGS is unlocking the potential of epigenetics, revolutionizing drug development, and enhancing diagnostic accuracy for personalized medicine.

Join us to get an insider's view on how NGS is not only changing the landscape of research but also making a profound impact on human health. Don't miss this informative conversation with a leading expert in the field!

Connect with Jonathon Hill:

LinkedIn: https://www.linkedin.com/in/jonathon-t-hill

Wasatch BioLabs: https://www.wasatchbiolabs.com

Next Steps:

Schedule your free assessment to take process development to the next level now at https://bruehlmann-consulting.com/assessment

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Unlock the future of epigenetics and join us for an insightful conversation with Jonathon Hill as he delves into the groundbreaking world of next-generation sequencing (NGS) and its transformative impact on science and medicine. Jonathon Hill is the VP of Science and Technology and a co-founder of Wasatch BioLabs and Associate Professor of Cell Biology and Physiology at Brigham Young University.

Discover how cutting-edge nanopore technology is overcoming the limitations of traditional methods and revolutionizing epigenetic research.

Key Takeaways:

1. Unparalleled Accuracy: Learn how nanopore technology achieves 99.6% accuracy in methylation calls, eliminating PCR and bisulfite conversion noise.
2. Comprehensive Insights: Understand the benefits of whole-molecule sequencing for detailed methylation analysis, providing a clearer, more precise picture of genetic data.
3. Future of Diagnostics: Explore the future of NGS in clinical settings, with genomic and epigenetic data integration into electronic health records guiding personalized treatments.

Don't miss this episode packed with innovative insights and the future landscape of genomic technology.

Connect with Jonathon Hill:

LinkedIn: https://www.linkedin.com/in/jonathon-t-hill

Wasatch BioLabs: https://www.wasatchbiolabs.com

Next Steps:

Schedule your free assessment to take process development to the next level now at https://bruehlmann-consulting.com/assessment

Send us a text

Dive into the latest episode as we explore how magnetic bead technology is revolutionizing downstream processing, promising higher yields and greater purity.

Our guest, Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, shares his insights on overcoming industry challenges and the future of purification. MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.

Key Takeaways:

1. Discover how magnetic beads integrate cell clarification and capture, reducing processing steps and mechanical stress.
2. Learn about the remarkable efficiency of magnetic beads in achieving low Host Cell Protein (HCP) levels right from the start.
3. Understand the economic benefits of this technology, from cost savings to increased throughput in large-scale facilities.

Ready to elevate your bioprocessing game? Tune in now and harness the power of magnetic bead technology.

Connect with Nils Brechmann:

LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114a

MAGic BioProcessing: https://magicbioprocessing.com

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Dive into the future of bioprocessing with Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, as we explore how magnetic bead technology is transforming downstream processing.

MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.

Key Takeaways:

1. Streamlined Purification: Discover how magnetic beads enable simultaneous clarification and capture, boosting efficiency.
2. Cost Savings: Learn about significant cost reductions by integrating steps and improving process economics.
3. Scalable Solutions: Understand the potential for large-scale applications, making magnetic bead technology a versatile option for biomanufacturing.

Join us for an in-depth look at the benefits and innovations of magnetic bead technology in modern bioprocessing.

Connect with Nils Brechmann:

LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114a

MAGic BioProcessing: https://magicbioprocessing.com

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Are sound waves the key to revolutionizing gene therapy? In this groundbreaking episode, we sit down with Gabriel Dumy, CTO and Co-founder at Kolibri, a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.

Gabriel shares the challenges facing modern bioproduction and unveils an exciting solution that's setting the stage for the future of gene therapy.

Key Takeaways:

1. Enhanced Cell Productivity: Discover how acoustic waves minimize shear stress, significantly boosting mammalian cell productivity and density.
2. Versatile Bioreactor Design: Learn about a cell-agnostic technology that seamlessly adapts to various cell lines, simplifying process development.
3. Scalable Innovation: Understand the potential of this scalable tech to maintain consistent microenvironments, paving the way for large-scale gene therapy production.

Tune in to find out how acoustic waves could be the breakthrough gene therapy has been waiting for!

Connect with Gabriel Dumy

LinkedIn: https://www.linkedin.com/in/gabrieldumy

Kolibri: https://www.kolibrilab.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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Could sound waves be the revolutionary key to gene therapy manufacturing? In this episode, Gabriel Dumy, CTO and Co-founder at Kolibri, reveals how acoustic waves are set to transform cell harvesting and gene transfection processes, making biomanufacturing more efficient and less damaging to cells.

Kolibri is a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.

Key Takeaways:

1. Real-Time Cell Harvesting: Discover how reconfigurable acoustic waves enable non-damaging, precise cell harvesting without the need for harsh chemicals.
2. Enhanced Gene Transfection: Learn about breakthrough methods to make cell membranes more permeable, dramatically improving the efficiency of gene delivery.
3. Scalable Bioproduction: Understand the scalable potential of acoustic waves in bioreactors, offering innovative solutions for complex tissue engineering and fragile cell growth.

Join us to explore how these advancements could revolutionize the future of gene therapy and beyond!

Connect with Gabriel Dumy

LinkedIn: https://www.linkedin.com/in/gabrieldumy

Kolibri: https://www.kolibrilab.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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Picture a world where we can freeze cells and bring them back to life perfectly intact.

In this episode, we're joined by Mark Davison, a leading expert in cryopreservation and CEO of Grant Instruments to uncover the intricate science of freezing and thawing cells. From basic principles to advanced techniques, we delve into how cryopreservation is revolutionizing biotechnology and cell therapies.

Key Takeaways:

1. Cell Survival Secrets: Discover why water is both a friend and foe in preserving cell viability, and how precise control over freezing rates can prevent cell damage.
2. Advanced Techniques: Learn about cutting-edge technologies that ensure safe and effective cryopreservation, minimizing risks associated with traditional methods like liquid nitrogen.
3. Automation in Cryopreservation: Understand the future of lab workflows with automation, reducing human error and increasing reproducibility in cell-based experiments.

Tune in to explore how cryopreservation is shaping the future of biotech!

Connect with Mark Davison:

LinkedIn: https://www.linkedin.com/in/markdavison100

The Big Experiment podcast: https://thebigexperiment.buzzsprout.com

Grant Instruments: https://www.grantinstruments.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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Get ready to dive into the fascinating world of cryopreservation!

In this episode, we welcome Mark Davison, an experienced entrepreneur and CEO of Grant Instruments, leaders in laboratory equipment, to explore the intricate science of freezing and thawing cells.

Mark brings his wealth of experience to demystify this crucial process, revealing how cutting-edge technology ensures precision and reliability in preserving biological samples.

Key Takeaways:

1. Mastering Precision: Learn how data acquisition and controlled rate freezing are essential to maintaining the integrity of your samples.
2. Technological Advancements: Discover the latest innovations transforming laboratory practices, from analog to digital conversions to remote monitoring.
3. Entrepreneurial Insights: Gain valuable advice on leveraging support systems and cultivating a collaborative culture to succeed in scientific entrepreneurship.

Tune in for an insightful conversation that blends technical expertise with practical advice, perfect for scientists and entrepreneurs alike!

Connect with Mark Davison:

LinkedIn: https://www.linkedin.com/in/markdavison100

The Big Experiment podcast: https://thebigexperiment.buzzsprout.com

Grant Instruments: https://www.grantinstruments.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Want to turn your biotech chaos into streamlined success? Learn from expert Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, on how process mapping can transform your knowledge management and elevate your business performance.

Key Takeaways:

1. Eliminate Scope Creep: Learn how to maintain focus in projects despite shifts and changes, improving productivity and reducing frustration.
2. Bridge Experience Gaps: Understand how process mapping creates a common language, enabling seamless knowledge transfer between seasoned experts and newcomers.
3. Enhance Systematic Approach: Discover the power of standardization and continuous improvement to boost overall business performance.

Tune in to uncover practical strategies that can transform your knowledge management practices and drive your biotech endeavors to new heights.

Connect with Irwin Hirsh:

LinkedIn: https://www.linkedin.com/in/ishirsh

Q-Specialists AB: https://www.qspecialists.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Join us as we explore the pivotal role of process mapping in biotech knowledge management. Our guest, Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, shares invaluable insights into leveraging technology to streamline operations.

Key Insights:

1. Identifying Critical Process Knowledge: Learn strategies to identify and manage vital process knowledge essential for optimal performance.
2. Transitioning from Implicit to Explicit Knowledge: Discover why converting hidden, tribal wisdom into structured, accessible information is crucial for scalability and continuity.
3. Harnessing Digital Tools: Explore effective approaches to digital transformation, ensuring seamless integration and collaboration across teams and time zones.

Join us as Irwin uncovers actionable steps to enhance efficiency and innovation in biotech through strategic process mapping.

Connect with Irwin Hirsh:

LinkedIn: https://www.linkedin.com/in/ishirsh

Q-Specialists AB: https://www.qspecialists.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Uncover the hidden science behind creating safer, more effective biological drugs! Dive into glycoanalytics and glycoengineering, the secret weapons revolutionizing biopharma.

Join us as we talk with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, who breaks down the complexities of glycosylation and its pivotal role in drug development.

Key Takeaways:

1. Critical Quality Attributes: Understand how glycans influence the function and structure of biopharmaceutical products, enhancing their efficacy and safety.
2. Analytical Techniques: Learn about the three major approaches—native glycoprotein analysis, glycopeptide analysis, and released glycan analysis—each providing unique insights into glycosylation.
3. Future Trends: Discover how automation, AI, and advanced mass spectrometry are revolutionizing glycoanalytics, making it more accessible and precise.

Tune in to explore how glycoanalytics is driving the next generation of safer, more effective biopharmaceuticals!

Connect with Róisín O’Flaherty:

LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8a

Twitter: https://x.com/irishglycogirl

Next Steps:

Book a free assessment to help you get started with glycoanalytics and glycoengineering at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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In this insightful episode, we explore the cutting-edge field of glycoengineering and its transformative impact on biopharmaceutical drug design. Join us as we chat with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, to uncover the nuances of chemoenzymatic glycogen engineering and its potential to revolutionize therapeutics.

Key Takeaways:

1. Understanding Glycoengineering: Discover the three main approaches—genetic, metabolomic, and chemoenzymatic—for modifying glycosylation and enhancing drug properties.
2. Real-World Applications: Learn how industry giants are leveraging glycoengineering to innovate cancer treatments and other therapies.
3. Future of Glycoanalytics: Explore how AI and machine learning are poised to further advance the precision and efficiency of glycoengineering.

Don't miss this deep dive into how glycoanalytics is paving the way for more effective and personalized biopharmaceutical drugs. Tune in to understand the future of drug design and the exciting possibilities it holds.

Connect with Róisín O’Flaherty:

LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8a

Twitter: https://x.com/irishglycogirl

Next Steps:

Book a free assessment to help you get started with glycoanalytics and glycoengineering at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Are you navigating the complex world of bioprocess CMC development and manufacturing in a small biotech company?

Our latest episode is a must-listen! Join us as we sit down with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, who shares invaluable insights on overcoming the unique challenges faced by small biotech firms.

In this episode, we explore:

1. The critical communication strategies needed for successful outsourcing to CDMOs.
2. How small biotechs can leverage their agility to make fast, impactful decisions.
3. The surprising benefits of wearing multiple hats and fostering cross-functional expertise.

Tune in to discover how mastering these areas can help your small biotech thrive and stay ahead in a competitive market.

Don't miss this opportunity to gain practical advice and turn your challenges into advantages!

Connect with Mark Melville:

LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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How do small biotech companies make strategic decisions with limited resources? This episode dives deep into the art of prioritization and outsourcing to achieve success.

Join us as we speak with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, a seasoned biotech scientist with years of experience in both large and small biotech companies. Mark shares his invaluable insights on navigating the complexities of bioprocess development and outsourcing.

In this episode, we explore:

1. Discover the secrets to prioritizing projects for maximum impact
2. Leverage outsourcing for flexibility and expertise
3. Learn to build strong relationships with external vendors to ensure top-notch quality and regulatory compliance.

Connect with Mark Melville:

LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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Ready to revolutionize your lab work? Join us as we dive deep into bead-based assays with Sebastian Giehring, CEO and founder of PAIA Biotech.

Discover how these tiny beads are making a massive impact on biotech research and development — for titer, glycan, and aggreation screening — and how this developability screening platform can enhance your antibody discovery, antibody engineering and lead optimization.

In this episode, you’ll learn:

1. Speed and Simplicity: How bead-based assays offer unmatched throughput and ease of use, allowing you to analyze hundreds of samples in just a few steps.
2. Versatile Applications: The diverse applications of bead-based assays in cell development, bioprocessing, and antibody discovery, helping streamline workflows and enhance innovation.
3. Early Screening Advantages: The benefits of bead-based assays in early-stage process development, enabling quick decision-making with less detailed but rapid results.

Tune in to uncover how these assays can transform your biotech research and push the boundaries of what's possible!

Connect with Sebastian Giehring:

LinkedIn: https://www.linkedin.com/in/sebastian-giehring-6ba1992

PAIA Biotech: https://www.paiabio.com

Next Steps:

Book a free assessment to help you get started with the design of your next experiment at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Dive into the transformative world of bead-based assays with Sebastian Giehring, CEO and founder of PAIA Biotech, where high-throughput screening meets cutting-edge biotechnological advancements.

Join us as we chat with Sebastian, a seasoned scientist and entrepreneur who has revolutionized the workflow of high-throughput screening of titer, glycosylation, and aggregation with innovative bead-based assays.

Key Takeaways:

1. Streamlined Workflow: Learn how a simplified sample prep can enhance efficiency and accuracy in glycosylation and aggregation screenings.
2. Optimized Experiment Design: Discover the critical do's and don'ts in designing robust experiments that yield meaningful results.
3. Future of Screening: Explore how AI and machine learning are set to revolutionize the biotechnological landscape, driving better drug development and process optimization.

Tune in to uncover how these insights can transform your lab's capabilities and drive groundbreaking discoveries!

Connect with Sebastian Giehring:

LinkedIn: https://www.linkedin.com/in/sebastian-giehring-6ba1992

PAIA Biotech: https://www.paiabio.com

Next Steps:

Book a free assessment to help you get started with the design of your next experiment at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Ever wondered how single-cell analysis could revolutionize bioprocessing? Join us in this episode as we delve into the cutting-edge world of impedance flow cytometry.

Furkan Gökçe, New Business Development Manager at Amphasys, shares his insights on the transformative power of this technology in the biotech industry. With a background in engineering and physics, Furkan provides a unique perspective on tackling the complexities of biological systems.

Key Takeaways:

1. Enhanced Process Control: Learn how impedance flow cytometry offers high-resolution, label-free analysis of individual cells, ensuring optimal growth conditions and quality production.
2. Understanding Cell Heterogeneity: Discover the importance of single-cell analysis in revealing critical variations within cell populations that bulk measurements often miss.
3. Innovation in Bioprocessing: Explore the advancements in microfabrication techniques that make real-time, high-throughput cell analysis possible, revolutionizing bioprocessing efficiency and accuracy.

Tune in to gain valuable knowledge on how this innovative technology can enhance your bioprocess development and manufacturing strategies!

Connect with Furkan Gökçe:

LinkedIn: https://www.linkedin.com/in/furkangokce

Amphasys: https://amphasys.com/bioprocessing

Next Steps:

Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Curious about the latest innovations in cell analysis technology? Join us in this episode with Furkan Gökçe, New Business Development Manager at Amphasys, as we delve into the fascinating world of Impedance Flow Cytometry (IFC).

Furkan shares how IFC is revolutionizing single-cell analysis by providing faster, more precise, and high-resolution data.

Key Takeaways:

1. Real-Time Precision: Discover how IFC allows for real-time, label-free assessments of cells, providing detailed insights into their natural state.
2. Enhanced Process Control: Learn how IFC can detect early signs of nutrient deficiencies and contaminants, leading to timely interventions and improved bioreactor outcomes.
3. Versatile Applications: Hear about practical applications, from brewing to protein production, where IFC has significantly boosted yields and process efficiency.

Tune in to uncover how IFC is set to transform the landscape of bioprocessing, ensuring better quality and sustainability in biologics production.

Connect with Furkan Gökçe:

LinkedIn: https://www.linkedin.com/in/furkangokce

Amphasys: https://amphasys.com/bioprocessing

Next Steps:

Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Unlock the secrets of cell factories and discover how cutting-edge technologies are revolutionizing biopharmaceutical production. In this episode, we welcome Mauro Torres, a postdoctoral researcher at the University of Manchester, who takes us on a fascinating journey through the complex world of protein manufacturing.

Mauro Torres explains the intricate steps involved in the secretory pathway, from gene expression to protein export, likening it to a sophisticated car manufacturing process. He then delves into how omics technologies and systems-level approaches are enhancing our understanding of cell physiology and improving production effectiveness.

Listeners will gain valuable insights into:

1. The potential of AI and machine learning to navigate vast amounts of bioprocess data
2. How synthetic biology is creating cells with new functionalities and improved adaptability
3. The exciting future of biopharmaceutical production as technologies converge

Discover how these advancements are paving the way for more predictable, affordable, and robust medicine production, promising a brighter future for patients worldwide.

Connect with Mauro Torres:

Linkedin: https://www.linkedin.com/in/mauro-torres-seb

Next Steps:

Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.com

Send us a text

Are shake flasks outdated relics or untapped goldmines of bioprocess development? In this eye-opening episode, we dive deep with Jens Bayer, a deep tech entrepreneur and seasoned commercial leader, currently serving as Chief Commercial Officer at Scientific Bioprocessing.

Jens shatters common misconceptions about shake flasks, revealing why they remain indispensable tools in both industry and research settings.

Discover:

1. Why shake flasks are irreplaceable for rapid, cost-effective experimentation
2. How to overcome the "black box" challenge and extract crucial data
3. Strategies to optimize shake flask processes for better scalability

From startups to Big Pharma, learn how mastering shake flask techniques can accelerate your bioprocess development and save precious resources. Whether you're a seasoned biotech pro or just starting out, this episode will transform how you approach early-stage bioprocessing.

Ready to revolutionize your lab work? Tune in now and unlock the hidden potential of shake flasks!

Connect with Jens Bayer:

LinkedIn: https://www.linkedin.com/in/jens-bayer-65a46350

Scientific Bioprocessing: https://www.scientificbio.com

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Unlock the secrets of cell factories with Mauro Torres, a postdoctoral researcher at the University of Manchester who brings cutting-edge insights into protein production. Discover how the concept of cell factories has evolved from basic insulin extraction to groundbreaking treatments for genetic disorders and cancer. We reveal the challenges faced by biotech scientists in bioprocess development and offers a fascinating analogy between car manufacturing and cellular protein assembly.

Learn how recent advancements in synthetic biology, genetic editing, and AI-driven process optimization are transforming the biopharmaceutical industry. From transposon technology to microfluidics and hybrid modeling, We explore the game-changing innovations that are accelerating cell line development and enhancing protein secretion.

Gain valuable insights into:

1. The evolution of cell factories
2. Cutting-edge technologies revolutionizing bioprocessing
3. Strategies for reprogramming cells for enhanced protein production

Don't miss this episode packed with expert knowledge on the future of biomanufacturing.

Connect with Mauro Torres:

Linkedin: https://www.linkedin.com/in/mauro-torres-seb

Next Steps:

Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.com

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Ever wondered what it takes to build a large-scale biotech manufacturing facility? Alfredo Martínez Mogarra, a seasoned Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets behind successful biotech facility design and scale-up. He has been at the forefront of transforming bench processes into industrial realities.

In this eye-opening episode, Alfredo shares critical insights on navigating the complex world of biotech manufacturing. Listeners will gain:

1. A deep understanding of the key factors in designing efficient biotech facilities
2. Strategies to mitigate risks when scaling up processes
3. Tips for fostering successful interdisciplinary collaboration

Whether you're a biotech scientist, engineer, or industry professional, this episode is packed with invaluable wisdom to elevate your bioprocessing game.

Tune in now and learn how to think holistically about biotech facility design.

Connect with Alfredo Martínez Mogarra:

LinkedIn: https://www.linkedin.com/in/alfredo-martínez-mogarra-a381087

Biotech Academy in Rome: https://www.biotechacademy.eu

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Ever wondered why some biotech facilities thrive while others struggle Alfredo Martínez Mogarra, a Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets to successful biotech manufacturing.

In this eye-opening episode, Alfredo shares critical insights on bridging the gap between lab-scale processes and industrial production.

You will get:

1. Strategies for seamless scale-up and risk mitigation in bioprocess development
2. Tips for fostering crucial interdepartmental collaboration in biotech facilities
3. Guidance on leveraging automation and AI for enhanced process control and predictability

Whether you're a biotech scientist, engineer, or industry professional, this episode is packed with invaluable wisdom to elevate your facility design and operations.

Don't miss Alfredo's golden rule: "Think very well before starting doing things." Tune in now and learn how to build a foundation for biotech success!

Connect with Alfredo Martínez Mogarra:

LinkedIn: https://www.linkedin.com/in/alfredo-martínez-mogarra-a381087

Biotech Academy in Rome: https://www.biotechacademy.eu

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Discover how scientists are transforming lives through innovative muscle regeneration therapy. In this captivating episode, Deana Mohr, CEO and co-founder of MUVON Therapeutics, spin-off from the University of Zurich, unveils her groundbreaking autologous muscle regeneration technology for treating stress urinary incontinence.

Learn how this minimally invasive treatment harnesses the power of a patient's own cells to restore muscle function, offering hope to millions. Diana shares her journey from PhD research to clinical trials, revealing the challenges of translating cutting-edge science into real-world treatments.

Listeners will gain insights on:

1. The potential of autologous muscle tissue regeneration and the hurdles of medical innovation.
2. Navigating the complex path from lab to clinic
3. Key differences between muscle-based and CAR-T cell therapies

Whether you're a scientist, investor, or simply curious about medical innovations, this episode offers a fascinating glimpse into the future of regenerative medicine. Tune in to explore the forefront of biotech entrepreneurship!

Connect with Deana Mohr:

LinkedIn: https://www.linkedin.com/in/deana-mohr-haralampieva-95a9a5a4

MUVON Therapeutics: https://www.muvon-therapeutics.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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Dive into the cutting-edge world of autologous cell-based therapy with Deana Mohr, CEO and co-founder of MUVON Therapeutics, spin-off from the University of Zurich. In this eye-opening episode, discover how MUVON Therapeutics’ innovative approach to muscle regeneration is revolutionizing treatments for stress urinary incontinence and beyond.

Learn how her team is tackling the challenges of bringing personalized medicine to market at scale, from navigating complex regulations to automating production processes.

Listeners will gain invaluable insights on:

1. Strategies for engaging with regulatory bodies to advance novel therapies
2. The crucial role of automation in making cell therapies accessible and affordable
3. Building successful partnerships to accelerate biotech innovation

Whether you're a scientist, investor, or healthcare professional, this episode offers a fascinating glimpse into the future of regenerative medicine. Tune in to explore how Deana's vision of "copy-paste" therapy production could transform millions of lives and reshape the biotech landscape!

Connect with Deana Mohr:

LinkedIn: https://www.linkedin.com/in/deana-mohr-haralampieva-95a9a5a4

MUVON Therapeutics: https://www.muvon-therapeutics.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Are your shake flasks holding back your bioprocess development? Discover how to transform them into smart bioreactors! In this game-changing episode, we talk with Jens Bayer about the groundbreaking DOTS platform. He is a deep tech entrepreneur and seasoned commercial leader, currently serving as Chief Commercial Officer at Scientific Bioprocessing.

Jens reveals how this cutting-edge technology is bridging the gap between simple shake flasks and complex bioreactors, offering scientists unprecedented control and data insights.

Learn how to:

1. Generate real-time growth curves and monitor key parameters without invasive sampling
2. Run fed-batch experiments in shake flasks, mimicking bioreactor conditions
3. Optimize your processes for better scalability and reproducibility

Whether you're a startup scientist or working in Big Pharma, this episode will revolutionize your approach to early-stage bioprocessing. Don't miss Jens' invaluable tips for designing successful shake flask experiments and his inspiring journey as a biotech entrepreneur.

Ready to supercharge your bioprocess development? Tune in now and unlock the hidden potential of your shake flasks!

Connect with Jens Bayer:

LinkedIn: https://www.linkedin.com/in/jens-bayer-65a46350

Scientific Bioprocessing: https://www.scientificbio.com

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Imagine a world where biologic drugs are produced faster, cheaper, and with unprecedented precision.

In this episode, we dive into that future with Professor Massimo Morbidelli, a trailblazer in bioprocessing innovation. As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.

From his groundbreaking work in continuous chromatography to spearheading AI-driven manufacturing, Morbidelli's 25-year journey has reshaped the biotech landscape.

Discover how initial industry skepticism transformed into widespread adoption of continuous processing and machine learning. Prof. Morbidelli shares insights on his current project: a fully automated, end-to-end manufacturing process for plasmid DNA production.

You will gain invaluable insights into:

1. The evolution of continuous bioprocessing and its impact on productivity and yield
2. How digitalization and machine learning are optimizing process development and manufacturing
3. The potential of transfer learning to dramatically reduce time-to-market for new biologics

Don't miss this opportunity to learn from a true visionary in the field.

Tune in now to unlock the secrets of next-generation biomanufacturing and stay ahead of the curve in this rapidly evolving industry.

Connect with Massimo Morbidelli:

Email: massimo “dot” morbidelli “at” polimi “dot” it

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

What if your biomanufacturing facility could run itself, optimize its own processes, and operate non-stop? This isn't science fiction – it's the cutting-edge reality Professor Massimo Morbidelli is helping to create.

In this captivating episode, the bioprocessing pioneer unveils how AI, continuous manufacturing, and revolutionary machine learning techniques are transforming the industry landscape.

As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.

Discover how transfer learning is revolutionizing process development across molecules and scales, dramatically reducing time-to-market for new biologics. Learn why the integration of computer science and biology is crucial for staying competitive in the rapidly evolving biopharma landscape.

You will gain invaluable insights on

1. Slashing development costs,
2. Maximizing productivity through 24/7 operations
3. Leveraging interdisciplinary knowledge to solve complex bioprocessing challenges

All are essential skills for thriving in the next era of biomanufacturing.

Tune in now and revolutionize your approach to biopharma innovation!

Connect with Massimo Morbidelli:

Email: massimo “dot” morbidelli “at” polimi “dot” it

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

Unlock the secrets of successful bioprocess development with host David Brühlmann as he shares hard-won lessons from his 15+ years of experience leading technology transfers and technology innovation projects.

Discover why prioritizing process development is crucial for transforming groundbreaking science into life-changing therapies. In this eye-opening episode, you'll learn:

1. How to avoid costly mistakes in technology transfer and scale-up, saving you time and resources
2. Strategies for balancing investor expectations with regulatory hurdles, keeping your project on track
3. Tips for building a robust risk management strategy that impresses investors and navigates challenges

From selecting the right cell lines to mastering the delicate dance of speed and quality, David unveils the hidden pitfalls that can derail even the most promising biotech innovations.

Whether you're a seasoned scientist or a curious entrepreneur, this episode is packed with actionable insights to supercharge your bioprocess development. Don't miss out – tune in now and take your biotech game to the next level!

Next Steps:

Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Unlock the secret weapon of biotech success! In this eye-opening episode, host David Brühlmann reveals how fractional CTOs are revolutionizing drug development, inspired by Michael Jordan's approach to greatness. Learn how this innovative strategy can slash timelines, mitigate risks, and give your biotech company a competitive edge.

Discover the game-changing benefits of fractional expertise:

1. Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.
2. Slash costs while tapping into C-level strategic guidance for critical growth phases.
3. Accelerate business development through valuable industry connections and insights.

Ready to transform your biotech journey? Tune in to explore how harnessing fractional expertise could be the catalyst your company needs.

Don't miss this opportunity to level up your drug development game – listen now and stay ahead in the fast-paced world of biotech innovation!

Next Steps:

Schedule your free call at https://bruehlmann-consulting.com/assessment to discover how you can develop biologics better, faster, at a fraction of the cost with our Fractional CTO services.

Send us a text

Unlock the mysteries of AAV manufacturing in this eye-opening episode! Ahmed, a seasoned AAV expert and Senior Process Development Manager at Ascend, reveals insider strategies for biotech scientists navigating the complex world of gene therapy production.

Discover why quality is the cornerstone of successful AAV development and how to avoid costly missteps in the journey from lab to clinic.

Key takeaways:

1. Learn to design a robust AAV manufacturing process that stands up to regulatory scrutiny
2. Master the art of balancing yield and quality for economically viable production
3. Gain insights into cutting-edge analytical tools that ensure your AAV's efficacy

From cell line selection to plasmid optimization, Ahmed breaks down the critical factors that can make or break your AAV project. Whether you're a biotech novice or a seasoned pro, this episode is packed with actionable advice to elevate your gene therapy game.

Ready to revolutionize your approach to AAV production? Tune in now!

Connect with Ahmed Youssef:

LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef

Ascend: https://www.ascend-adv.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Dive into the cutting-edge world of gene therapy as we unravel the complexities of AAV production. In this insightful episode, Ahmed Youssef, a seasoned AAV expert and Senior Process Development Manager at Ascend, explains how you can navigate the complex world of AAV scale-up and learn why thinking outside the box is crucial for success.

Key takeaways:

1. Leverage early expert advice to ensure your therapeutic's long-term viability
2. Explore innovative technologies like doggy bone DNA to reduce impurities
3. Gain insights from industry pioneers to revolutionize your AAV production process

From plasmid alternatives to cutting-edge CDMO strategies, this episode is packed with game-changing information. Don't miss out on these invaluable scale-up secrets that could transform your gene therapy projects.

Tune in now and take your AAV production skills to the next level!

Connect with Ahmed Youssef:

LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef

Ascend: https://www.ascend-adv.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Unlock the mysteries of oxygen transfer in bioreactors with mass transfer experts Lars Puiman and Rik Volger from the University of Delft. In this eye-opening episode, dive deep into the crucial world of kLa (oxygen mass transfer coefficient) and its impact on bioprocess scale-up.

Discover why understanding kLa is essential for optimizing cell growth and product formation in bioreactors. Learn practical strategies to enhance oxygen transfer, from manipulating bubble size to leveraging unexpected allies like ethanol. Our experts reveal:

1. How to increase mass transfer efficiency without breaking the bank
2. The surprising effects of broth composition on oxygen transfer rates
3. Cutting-edge sparger technologies for optimal aeration

Whether you're a seasoned bioprocess engineer or a curious scientist, this episode will revolutionize your approach to oxygen transfer in bioprocessing.

Don't miss these game-changing insights – tune in now!

Connect with our guests:

Lars Puiman: https://www.linkedin.com/in/larspuiman

Rik Volger:  https://www.linkedin.com/in/rikvolger

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Additional Resources:

Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamics

Read the review paper at https://doi.org/10.1016/j.bej.2023.109124

Send us a text

Ever wondered why your perfectly optimized lab process falls apart at industrial scale?

Mass transfer experts Lars Puiman and Rik Volger from the University of Delft reveal the hidden world of oxygen transfer and aeration that can make or break your production.

Dive into the crucial differences between lab-scale and industrial-scale bioreactors, and discover why your DO sensor might be fooling you. Learn how CFD simulations and innovative downscaling techniques can revolutionize your scale-up strategy.

In this episode, you'll gain:

1. Insider tips for predicting and managing concentration gradients in large-scale reactors
2. Cutting-edge methods to measure kLa accurately in industrial settings
3. Strategies to leverage microfluidics for cost-effective process development

From the basics of bubble behavior to the latest in AI and machine learning, this episode is packed with practical insights to enhance your bioprocess efficiency and product quality. Don't miss out on these game-changing mass transfer secrets – tune in now and take your bioprocessing skills to the next level!

Connect with our guests:

Lars Puiman: https://www.linkedin.com/in/larspuiman

Rik Volger:  https://www.linkedin.com/in/rikvolger

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Additional Resources:

Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamics

Read the review paper at https://doi.org/10.1016/j.bej.2023.109124

Send us a text

Discover how a failed optometry dream led Benjamin McLeod to become a leading voice in cell and gene therapy. In this eye-opening episode, Ben, who is a Cell & Gene Therapy Segment Lead at NanoMosaic, shares his unconventional path from lab work to LinkedIn stardom, revealing how he bridges the gap between R&D and marketing in biotech.

Learn how Ben's weekly science memes evolved into valuable content that attracts both lab techs and CEOs alike.

Key takeaways:

1. Gain insider tips on communicating complex science effectively
2. Learn how to leverage social media to build industry credibility
3. Discover the power of continuous learning in fast-paced biotech fields

Whether you're a seasoned scientist or biotech enthusiast, this episode offers invaluable insights into the art of scientific communication. Tune in now to transform your approach to biotech development and communicating science.

Connect with Benjamin McLeod:

LinkedIn: https://www.linkedin.com/in/benjamin-mcleod

NanoMosaic: https://www.nanomosaicllc.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

In this electrifying episode, we dive deep into the future of biotech with biotech influencer Benjamin McLeod. From quantum AI mapping cellular interactions to the game-changing potential of process analytical technology, Ben, who is also a Cell & Gene Therapy Segment Lead at NanoMosaic, unveils how artificial intelligence is set to transform the cell and gene therapy landscape.

Discover why LinkedIn is becoming the new frontier for biotech networking and career advancement. Learn how combining AI with PAT could slash production costs and boost yields in ways you've never imagined.

You will gain invaluable insights on:

1. Leveraging AI to optimize bioprocesses and reduce costs
2. The evolving landscape of viral and non-viral gene therapies
3. Strategies for breaking into the cell and gene therapy field

Don't miss this opportunity to stay ahead of the curve in biotech innovation. Tune in now and revolutionize your approach to bioprocessing!

Connect with Benjamin McLeod:

LinkedIn: https://www.linkedin.com/in/benjamin-mcleod

NanoMosaic: https://www.nanomosaicllc.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a text

Is AI the secret weapon biotech scientists have been waiting for? In this eye-opening episode, we dive deep into the world of AI-driven bioprocess development with Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode. Discover how AI is transforming the biotech landscape, from reducing downtime by 50% to unlocking unprecedented levels of precision in process optimization.

Key takeaways:

1. Learn how AI can slash experiment time by up to 80%, saving you valuable resources
2. Uncover the power of digital twins in fine-tuning your bioprocesses with unparalleled accuracy
3. Gain insights on overcoming data challenges to harness AI's full potential in your lab

Don't miss this game-changing discussion that could revolutionize your approach to bioprocess development. Tune in now and stay ahead of the curve in the rapidly evolving world of biotech!

Connect with Belma Alispahic:

LinkedIn: https://www.linkedin.com/in/balispahic

Analysis Mode: https://analysismode.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma.

Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's no longer optional but essential for success.

Key takeaways:

1. Leverage AI to streamline experiments, reduce costs, and accelerate your path to market
2. Gain insights into emerging AI technologies reshaping biopharma's future
3. Learn practical steps to integrate AI into your workflow, even with limited resources

Don't miss this opportunity to stay ahead of the curve and unlock the full potential of your biotech projects. Tune in now to empower your scientific journey and simplify complex bioprocessing challenges with AI-driven solutions.

Connect with Belma Alispahic:

LinkedIn: https://www.linkedin.com/in/balispahic

Analysis Mode: https://analysismode.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and industry.

Discover how he's now helping biotech startups align their technical strategies with commercial outcomes, accelerating their path to market.

You will gain invaluable insights on:

1. Navigating the transition from academia to industry
2. Scaling cell production from lab quantities to industrial volumes
3. Identifying and pivoting to the right target market for biotech innovations

Don't miss this eye-opening discussion on simplifying bioprocessing and bringing game-changing products to life. Tune in now to supercharge your biotech career!

Connect with James Ryall:

LinkedIn: https://www.linkedin.com/in/james-ryall

Website: https://www.jamesryall.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

Are you ready to dive into the cutting-edge world of biomanufacturing? In this episode, strategic consultant James Ryall unveils the staggering potential of bio-based products to revolutionize industries. From cultured meat to human breast milk, discover how cells are becoming the ultimate manufacturing facilities.

James shares invaluable insights on scaling challenges, regulatory hurdles, and the critical importance of early preparation for biotech startups. Learn why biomanufacturing is poised to transform up to 60% of consumer goods and how to stay ahead in this rapidly evolving field.

Gain expert strategies to:

1. Navigate scaling and regulatory challenges with confidence
2. Create bio-based products that outperform traditional alternatives
3. Tap into the immense opportunities in non-clinical biomanufacturing

Whether you're a seasoned bioprocessing expert or a curious entrepreneur, this episode will ignite your passion for the biotech revolution. Tune in now and discover how to ride the wave of biomanufacturing innovation!

Connect with James Ryall:

LinkedIn: https://www.linkedin.com/in/james-ryall

Website: https://www.jamesryall.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Send us a text

Are you ready to decode the future of bioprocessing? In this eye-opening episode, we dive deep into the world of digital bioprocess development with Fabian Feidl, co-founder and CTO of DataHow.

Discover how cutting-edge process models are transforming the biotech industry, bridging the gap between raw data and actionable insights.

Key takeaways:

1. Learn how process models can streamline development, reduce costs, and accelerate time-to-market for groundbreaking therapies.
2. Explore the game-changing potential of personalized medicine through predictive modeling in CAR T-cell therapy.
3. Uncover strategies to overcome organizational and technological barriers in adopting digital technologies for bioprocessing.

From optimizing experimental design to enabling data-driven decision-making, this episode is packed with invaluable insights for biotech scientists and leaders. Tune in now to unlock the future of bioprocessing and take your research to the next level!

Connect with Fabian Feidl:

LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3

DataHow: https://datahow.ch

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com