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
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Are shake flasks outdated relics or untapped goldmines of bioprocess development?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.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 8, 2024 • 18min
78: Cell Factories Explained: How Synthetic Biology and AI Revolutionize Protein Production with Mauro Torres - Part 2
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:The potential of AI and machine learning to navigate vast amounts of bioprocess dataHow synthetic biology is creating cells with new functionalities and improved adaptabilityThe exciting future of biopharmaceutical production as technologies convergeDiscover 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-sebNext Steps:Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.comSupport the show
Aug 6, 2024 • 23min
77: Cell Factories Explained: How Synthetic Biology and AI Revolutionize Protein Production with Mauro Torres - Part 1
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:The evolution of cell factoriesCutting-edge technologies revolutionizing bioprocessingStrategies for reprogramming cells for enhanced protein productionDon'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-sebNext Steps:Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.comSupport the show
Aug 1, 2024 • 25min
76: Transforming Single-Cell Analysis With Impedance Flow Cytometry w/ Furkan Gökçe - Part 2
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:Real-Time Precision: Discover how IFC allows for real-time, label-free assessments of cells, providing detailed insights into their natural state.Enhanced Process Control: Learn how IFC can detect early signs of nutrient deficiencies and contaminants, leading to timely interventions and improved bioreactor outcomes.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/furkangokceAmphasys: https://amphasys.com/bioprocessingNext Steps:Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.comDevelop 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
Jul 30, 2024 • 17min
75: Transforming Single-Cell Analysis With Impedance Flow Cytometry w/ Furkan Gökçe - Part 1
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:Enhanced Process Control: Learn how impedance flow cytometry offers high-resolution, label-free analysis of individual cells, ensuring optimal growth conditions and quality production.Understanding Cell Heterogeneity: Discover the importance of single-cell analysis in revealing critical variations within cell populations that bulk measurements often miss.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/furkangokceAmphasys: https://amphasys.com/bioprocessingNext Steps:Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.comDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.comSupport the show
Jul 25, 2024 • 17min
74: Bead-Based Assays: The Power of High-Throughput Screening w/ Sebastian Giehring - Part 2
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:Streamlined Workflow: Learn how a simplified sample prep can enhance efficiency and accuracy in glycosylation and aggregation screenings.Optimized Experiment Design: Discover the critical do's and don'ts in designing robust experiments that yield meaningful results.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-6ba1992PAIA Biotech: https://www.paiabio.comNext Steps:Book a free assessment to help you get started with the design of your next experiment at https://bruehlmann-consulting.comDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.comSupport the show
