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
Sep 12, 2024 • 17min
88: The Swiss Army Knife of Biotech: Unleashing the Power of Fractional Expertise
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:Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.Slash costs while tapping into C-level strategic guidance for critical growth phases.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.Support the show
Sep 10, 2024 • 17min
87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches
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:How to avoid costly mistakes in technology transfer and scale-up, saving you time and resourcesStrategies for balancing investor expectations with regulatory hurdles, keeping your project on trackTips for building a robust risk management strategy that impresses investors and navigates challengesFrom 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/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.comSupport the show
Sep 5, 2024 • 25min
86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 2
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 onSlashing development costs,Maximizing productivity through 24/7 operationsLeveraging interdisciplinary knowledge to solve complex bioprocessing challengesAll 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” itNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com🧬 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
Sep 3, 2024 • 26min
85: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 1
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:The evolution of continuous bioprocessing and its impact on productivity and yieldHow digitalization and machine learning are optimizing process development and manufacturingThe potential of transfer learning to dramatically reduce time-to-market for new biologicsDon'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” itNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com🧬 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
Aug 29, 2024 • 25min
84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens Bayer - Part 2
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:Generate real-time growth curves and monitor key parameters without invasive samplingRun fed-batch experiments in shake flasks, mimicking bioreactor conditionsOptimize your processes for better scalability and reproducibilityWhether 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-65a46350Scientific Bioprocessing: https://www.scientificbio.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com🧬 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
Aug 27, 2024 • 18min
83: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens Bayer - Part 1
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:Why shake flasks are irreplaceable for rapid, cost-effective experimentationHow to overcome the "black box" challenge and extract crucial dataStrategies to optimize shake flask processes for better scalabilityFrom 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-65a46350Scientific Bioprocessing: https://www.scientificbio.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.comSupport the show
Aug 22, 2024 • 18min
82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana Mohr - Part 2
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:Strategies for engaging with regulatory bodies to advance novel therapiesThe crucial role of automation in making cell therapies accessible and affordableBuilding successful partnerships to accelerate biotech innovationWhether 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-95a9a5a4MUVON Therapeutics: https://www.muvon-therapeutics.comNext 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/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.comSupport the show
Aug 20, 2024 • 23min
81: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana Mohr - Part 1
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:The potential of autologous muscle tissue regeneration and the hurdles of medical innovation.Navigating the complex path from lab to clinicKey differences between muscle-based and CAR-T cell therapiesWhether 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-95a9a5a4MUVON Therapeutics: https://www.muvon-therapeutics.comNext 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/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.comSupport the show
Aug 15, 2024 • 20min
80: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez Mogarra - Part 2
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:Strategies for seamless scale-up and risk mitigation in bioprocess developmentTips for fostering crucial interdepartmental collaboration in biotech facilitiesGuidance on leveraging automation and AI for enhanced process control and predictabilityWhether 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-a381087Biotech Academy in Rome: https://www.biotechacademy.euNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.comSupport the show
Aug 13, 2024 • 26min
79: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez Mogarra - Part 1
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:A deep understanding of the key factors in designing efficient biotech facilitiesStrategies to mitigate risks when scaling up processesTips for fostering successful interdisciplinary collaborationWhether 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-a381087Biotech Academy in Rome: https://www.biotechacademy.euNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com🧬 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
