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.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books
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
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.com🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport 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.com🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show
