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
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:Master bioprocess development with confidence and clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI can’t wait to help you do biotech the smart way.Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.Ready to transform your biomanufacturing journey? Let's dive in!Next Steps:Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-foundersAccelerate biologics development with expert guidance: https://bruehlmann-consulting.comFor sponsorship opportunities, contact us at hello@bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books
Jan 11, 2024 • 14min
18: How Extracting Gold From Your Data Accelerates Process Development w/ Ioscani Jiménez del Val - Part 2
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: @UcdCellLinkedIn: https://www.linkedin.com/in/ioscanijWebsite: https://people.ucd.ie/ioscani.jimenezdelvalSupport the show
Jan 9, 2024 • 19min
17: How Extracting Gold From Your Data Accelerates Process Development w/ Ioscani Jiménez del Val - Part 1
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: @UcdCellLinkedIn: https://www.linkedin.com/in/ioscanijWebsite: https://people.ucd.ie/ioscani.jimenezdelvalSupport the show
Dec 21, 2023 • 20min
16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat Thalmann - Part 2
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/beatthalmannWebsite: www.scinora.comSupport the show
Dec 19, 2023 • 18min
15: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat Thalmann - Part 1
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:Overcoming production challenges: Learn how you can tackle the hurdles in the development and scaling of cultivated meat production processes.Innovative techniques: Discover the cutting-edge approaches being employed by companies in the field, such as reimagining bioreactors and adopting media recycling practices.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/beatthalmannWebsite: www.scinora.comSupport the show
Dec 14, 2023 • 17min
14: Digital Transformation in Biomanufacturing: A Rapidly Moving Tech Frontier w/ Abhijeet Satwekar - Part 2
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: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.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.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/Support the show
Dec 12, 2023 • 17min
13: Digital Transformation in Biomanufacturing: A Rapidly Moving Tech Frontier w/ Abhijeet Satwekar - Part 1
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: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.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.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/Support the show
Dec 7, 2023 • 17min
12: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development - Part 2
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/Support the show
Dec 5, 2023 • 27min
11: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development - Part 1
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: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.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.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/🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show
Nov 30, 2023 • 16min
10: Revolutionizing Cell-Line Development: Unleashing the Power of Nanopens and Microenvironments w/ Tanner Nevill - Part 2
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: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.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.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/tannernevillWebsite: https://brukercellularanalysis.com/products/workflows/cell-line-developmentSupport the show
Nov 28, 2023 • 14min
09: Revolutionizing Cell-Line Development: Unleashing the Power of Nanopens and Microenvironments w/ Tanner Nevill - Part 1
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: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.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.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/tannernevillWebsite: https://brukercellularanalysis.com/products/workflows/cell-line-developmentSupport the show
