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
Jul 23, 2024 • 19min
73: Bead-Based Assays: The Power of High-Throughput Screening w/ Sebastian Giehring - Part 1
Ready to revolutionize your lab work? Join us as we dive deep into bead-based assays with Sebastian Giehring, CEO and founder of PAIA Biotech.Discover how these tiny beads are making a massive impact on biotech research and development — for titer, glycan, and aggreation screening — and how this developability screening platform can enhance your antibody discovery, antibody engineering and lead optimization.In this episode, you’ll learn:Speed and Simplicity: How bead-based assays offer unmatched throughput and ease of use, allowing you to analyze hundreds of samples in just a few steps.Versatile Applications: The diverse applications of bead-based assays in cell development, bioprocessing, and antibody discovery, helping streamline workflows and enhance innovation.Early Screening Advantages: The benefits of bead-based assays in early-stage process development, enabling quick decision-making with less detailed but rapid results.Tune in to uncover how these assays can transform your biotech research and push the boundaries of what's possible!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
Jul 18, 2024 • 22min
72: Effective Outsourcing: How Small Biotech Companies Can Thrive w/ Mark Melville - Part 2
How do small biotech companies make strategic decisions with limited resources? This episode dives deep into the art of prioritization and outsourcing to achieve success.Join us as we speak with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, a seasoned biotech scientist with years of experience in both large and small biotech companies. Mark shares his invaluable insights on navigating the complexities of bioprocess development and outsourcing.In this episode, we explore:Discover the secrets to prioritizing projects for maximum impactLeverage outsourcing for flexibility and expertiseLearn to build strong relationships with external vendors to ensure top-notch quality and regulatory compliance.Connect with Mark Melville:LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2Next 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
Jul 16, 2024 • 19min
71: Effective Outsourcing: How Small Biotech Companies Can Thrive w/ Mark Melville - Part 1
Are you navigating the complex world of bioprocess CMC development and manufacturing in a small biotech company?Our latest episode is a must-listen! Join us as we sit down with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, who shares invaluable insights on overcoming the unique challenges faced by small biotech firms.In this episode, we explore:The critical communication strategies needed for successful outsourcing to CDMOs.How small biotechs can leverage their agility to make fast, impactful decisions.The surprising benefits of wearing multiple hats and fostering cross-functional expertise.Tune in to discover how mastering these areas can help your small biotech thrive and stay ahead in a competitive market.Don't miss this opportunity to gain practical advice and turn your challenges into advantages!Connect with Mark Melville:LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2Next 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
Jul 11, 2024 • 16min
70: Glycoanalytics Explained: Analysing and Designing Better Biopharmaceutical Drugs w/ Róisín O’Flaherty - Part 2
In this insightful episode, we explore the cutting-edge field of glycoengineering and its transformative impact on biopharmaceutical drug design. Join us as we chat with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, to uncover the nuances of chemoenzymatic glycogen engineering and its potential to revolutionize therapeutics.Key Takeaways:Understanding Glycoengineering: Discover the three main approaches—genetic, metabolomic, and chemoenzymatic—for modifying glycosylation and enhancing drug properties.Real-World Applications: Learn how industry giants are leveraging glycoengineering to innovate cancer treatments and other therapies.Future of Glycoanalytics: Explore how AI and machine learning are poised to further advance the precision and efficiency of glycoengineering.Don't miss this deep dive into how glycoanalytics is paving the way for more effective and personalized biopharmaceutical drugs. Tune in to understand the future of drug design and the exciting possibilities it holds.Connect with Róisín O’Flaherty:LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8aTwitter: https://x.com/irishglycogirlNext Steps:Book a free assessment to help you get started with glycoanalytics and glycoengineering 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
Jul 9, 2024 • 18min
69: Glycoanalytics Explained: Analysing and Designing Better Biopharmaceutical Drugs w/ Róisín O’Flaherty - Part 1
Uncover the hidden science behind creating safer, more effective biological drugs! Dive into glycoanalytics and glycoengineering, the secret weapons revolutionizing biopharma.Join us as we talk with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, who breaks down the complexities of glycosylation and its pivotal role in drug development.Key Takeaways:Critical Quality Attributes: Understand how glycans influence the function and structure of biopharmaceutical products, enhancing their efficacy and safety.Analytical Techniques: Learn about the three major approaches—native glycoprotein analysis, glycopeptide analysis, and released glycan analysis—each providing unique insights into glycosylation.Future Trends: Discover how automation, AI, and advanced mass spectrometry are revolutionizing glycoanalytics, making it more accessible and precise.Tune in to explore how glycoanalytics is driving the next generation of safer, more effective biopharmaceuticals!Connect with Róisín O’Flaherty:LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8aTwitter: https://x.com/irishglycogirlNext Steps:Book a free assessment to help you get started with glycoanalytics and glycoengineering 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
Jul 4, 2024 • 31min
68: How Process Mapping Transforms Knowledge Management in Biotech w/ Irwin Hirsh - Part 2
Join us as we explore the pivotal role of process mapping in biotech knowledge management. Our guest, Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, shares invaluable insights into leveraging technology to streamline operations.Key Insights:Identifying Critical Process Knowledge: Learn strategies to identify and manage vital process knowledge essential for optimal performance.Transitioning from Implicit to Explicit Knowledge: Discover why converting hidden, tribal wisdom into structured, accessible information is crucial for scalability and continuity.Harnessing Digital Tools: Explore effective approaches to digital transformation, ensuring seamless integration and collaboration across teams and time zones.Join us as Irwin uncovers actionable steps to enhance efficiency and innovation in biotech through strategic process mapping.Connect with Irwin Hirsh:LinkedIn: https://www.linkedin.com/in/ishirshQ-Specialists AB: https://www.qspecialists.comNext Steps:Wondering how to develop biologics and cell & 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 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
Jul 2, 2024 • 14min
67: How Process Mapping Transforms Knowledge Management in Biotech w/ Irwin Hirsh - Part 1
Want to turn your biotech chaos into streamlined success? Learn from expert Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, on how process mapping can transform your knowledge management and elevate your business performance.Key Takeaways:Eliminate Scope Creep: Learn how to maintain focus in projects despite shifts and changes, improving productivity and reducing frustration.Bridge Experience Gaps: Understand how process mapping creates a common language, enabling seamless knowledge transfer between seasoned experts and newcomers.Enhance Systematic Approach: Discover the power of standardization and continuous improvement to boost overall business performance.Tune in to uncover practical strategies that can transform your knowledge management practices and drive your biotech endeavors to new heights.Connect with Irwin Hirsh:LinkedIn: https://www.linkedin.com/in/ishirshQ-Specialists AB: https://www.qspecialists.comNext Steps:Wondering how to develop biologics and cell & 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 https://bruehlmann-consulting.comSupport the show
Jun 27, 2024 • 16min
66: Freezing and Thawing Cells: the Science Behind Cryopreservation w/ Mark Davison - Part 2
Get ready to dive into the fascinating world of cryopreservation!In this episode, we welcome Mark Davison, an experienced entrepreneur and CEO of Grant Instruments, leaders in laboratory equipment, to explore the intricate science of freezing and thawing cells.Mark brings his wealth of experience to demystify this crucial process, revealing how cutting-edge technology ensures precision and reliability in preserving biological samples.Key Takeaways:Mastering Precision: Learn how data acquisition and controlled rate freezing are essential to maintaining the integrity of your samples.Technological Advancements: Discover the latest innovations transforming laboratory practices, from analog to digital conversions to remote monitoring.Entrepreneurial Insights: Gain valuable advice on leveraging support systems and cultivating a collaborative culture to succeed in scientific entrepreneurship.Tune in for an insightful conversation that blends technical expertise with practical advice, perfect for scientists and entrepreneurs alike!Connect with Mark Davison:LinkedIn: https://www.linkedin.com/in/markdavison100The Big Experiment podcast: https://thebigexperiment.buzzsprout.comGrant Instruments: https://www.grantinstruments.comNext Steps:Wondering how to develop biologics and cell & 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 https://bruehlmann-consulting.comSupport the show
Jun 25, 2024 • 26min
65: Freezing and Thawing Cells: the Science Behind Cryopreservation w/ Mark Davison - Part 1
Picture a world where we can freeze cells and bring them back to life perfectly intact.In this episode, we're joined by Mark Davison, a leading expert in cryopreservation and CEO of Grant Instruments to uncover the intricate science of freezing and thawing cells. From basic principles to advanced techniques, we delve into how cryopreservation is revolutionizing biotechnology and cell therapies.Key Takeaways:Cell Survival Secrets: Discover why water is both a friend and foe in preserving cell viability, and how precise control over freezing rates can prevent cell damage.Advanced Techniques: Learn about cutting-edge technologies that ensure safe and effective cryopreservation, minimizing risks associated with traditional methods like liquid nitrogen.Automation in Cryopreservation: Understand the future of lab workflows with automation, reducing human error and increasing reproducibility in cell-based experiments.Tune in to explore how cryopreservation is shaping the future of biotech!Connect with Mark Davison:LinkedIn: https://www.linkedin.com/in/markdavison100The Big Experiment podcast: https://thebigexperiment.buzzsprout.comGrant Instruments: https://www.grantinstruments.comNext Steps:Wondering how to develop biologics and cell & 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 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
Jun 20, 2024 • 22min
64: Why Sound Waves Are the Future of Gene Therapy Bioreactors w/ Gabriel Dumy - Part 2
Could sound waves be the revolutionary key to gene therapy manufacturing? In this episode, Gabriel Dumy, CTO and Co-founder at Kolibri, reveals how acoustic waves are set to transform cell harvesting and gene transfection processes, making biomanufacturing more efficient and less damaging to cells.Kolibri is a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.Key Takeaways:Real-Time Cell Harvesting: Discover how reconfigurable acoustic waves enable non-damaging, precise cell harvesting without the need for harsh chemicals.Enhanced Gene Transfection: Learn about breakthrough methods to make cell membranes more permeable, dramatically improving the efficiency of gene delivery.Scalable Bioproduction: Understand the scalable potential of acoustic waves in bioreactors, offering innovative solutions for complex tissue engineering and fragile cell growth.Join us to explore how these advancements could revolutionize the future of gene therapy and beyond!Connect with Gabriel DumyLinkedIn: https://www.linkedin.com/in/gabrieldumyKolibri: https://www.kolibrilab.comNext Steps:Wondering how to develop biologics and cell & 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 https://bruehlmann-consulting.comSupport the show
