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
Feb 15, 2024 • 13min
28: How to Simplify Project Management in Bioprocess Development - Part 2
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:Discover the secret to 'Successful Planning,' - a strategy to ensure your projects are well-organised, resource-smart, and timely delivered.Understand the crucial role of 'Assessing Scalability Potential,' and why it's a game-changer for your project's long-term success.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:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Feb 13, 2024 • 16min
27: How to Simplify Project Management in Bioprocess Development - Part 1
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:Uncover how to "Plan for Success," ensuring your projects are well-structured, resource-efficient, and delivered on time.Learn the importance of "Evaluating the Scalability Potential," and why it's crucial for the long-term success of your project.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:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Feb 8, 2024 • 13min
26: 9 Critical Steps for a Seamless Transition to Large-Scale Production - Part 2
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:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Feb 6, 2024 • 19min
25: 9 Critical Steps for a Seamless Transition to Large-Scale Production - Part 1
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:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Feb 1, 2024 • 23min
24: Strategies for Success: Master CMC Development with Gene Lee - Part 2
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.Conduct Early Developability Assessments: By assessing productivity, aggregation propensity, and manufacturability early on, you can strategically avoid future roadblocks.Use a Platform: A platform approach facilitates swift and cost-effective transitions to clinical trials, reducing pre-proof of concept investment.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-0318b83Website: www.altrubio.comNext Step:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Jan 30, 2024 • 18min
23: Strategies for Success: Master CMC Development with Gene Lee - Part 1
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: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.Collaborate: CMC development should not work in isolation but integrate insights from diverse teams for a comprehensive drug development strategy.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-0318b83Website: www.altrubio.comNext Step:Elevate your bioprocess development strategy — Grab your free assessment now: https://bruehlmann-consulting.comSupport the show
Jan 25, 2024 • 19min
22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata - Part 2
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: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.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.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-84647579Website: www.cytofacto.com/engGet 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-biomanufacturingLearn more about the upcoming Cell and Gene Therapy Training program for the Asia Pacific region: contact David at hello@bruehlmann-consulting.comSupport the show
Jan 23, 2024 • 22min
21: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata - Part 1
Shin Kawamata, CEO of Cyto-Facto Inc., discusses revolutionizing cell manufacturing by merging public sector support with commercial viability. He emphasizes the importance of Quality by Design strategies in cell therapy manufacturing and shares insights on scaling up cell therapies efficiently through automation, digitalization, and QbD. The podcast delves into specific quality requirements for mass culture of stem cells and CAR-T therapy, highlighting the significance of maintaining youth in CAR-T therapy.
Jan 18, 2024 • 17min
20: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 2
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/cdmoadvisorArticle: 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-0001Support the show
Jan 16, 2024 • 20min
19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1
Guest Bernardo Estupiñán Gaisbauer shares insights on transitioning molecules to clinical trials. Emphasizes Developability and Manufacturability importance. Advises starting early, finding balance with regulatory aspects, and optimizing manufacturing. Discusses challenges, strategic decision-making, and engaging potential partners early on.
