Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.This podcast is for you if:You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnershipYou are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readinessYou are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutinyYou are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resourcesWhat you will learn:CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.Next Steps:Visit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books
Oct 1, 2024 • 26min
93: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer - Part 1
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:Gain insider tips on communicating complex science effectivelyLearn how to leverage social media to build industry credibilityDiscover the power of continuous learning in fast-paced biotech fieldsWhether 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-mcleodNanoMosaic: https://www.nanomosaicllc.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.comOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show
Sep 26, 2024 • 16min
92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger - Part 2
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:Insider tips for predicting and managing concentration gradients in large-scale reactorsCutting-edge methods to measure kLa accurately in industrial settingsStrategies to leverage microfluidics for cost-effective process developmentFrom 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/larspuimanRik Volger: https://www.linkedin.com/in/rikvolgerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentAdditional Resources:Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamicsRead the review paper at https://doi.org/10.1016/j.bej.2023.109124Support the show
Sep 24, 2024 • 17min
91: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger - Part 1
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:How to increase mass transfer efficiency without breaking the bankThe surprising effects of broth composition on oxygen transfer ratesCutting-edge sparger technologies for optimal aerationWhether 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/larspuimanRik Volger: https://www.linkedin.com/in/rikvolgerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentAdditional Resources:Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamicsRead the review paper at https://doi.org/10.1016/j.bej.2023.109124Support the show
Sep 19, 2024 • 27min
90: Scale-Up Secrets: Cracking the Code of AAV Production with Ahmed Youssef - Part 2
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:Leverage early expert advice to ensure your therapeutic's long-term viabilityExplore innovative technologies like doggy bone DNA to reduce impuritiesGain insights from industry pioneers to revolutionize your AAV production processFrom 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-youssefAscend: https://www.ascend-adv.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.comOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show
Sep 17, 2024 • 20min
89: Scale-Up Secrets: Cracking the Code of AAV Production with Ahmed Youssef - Part 1
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:Learn to design a robust AAV manufacturing process that stands up to regulatory scrutinyMaster the art of balancing yield and quality for economically viable productionGain insights into cutting-edge analytical tools that ensure your AAV's efficacyFrom 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-youssefAscend: https://www.ascend-adv.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
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.comOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support 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.comOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support 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.comOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show
