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
Nov 21, 2024 • 28min
108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 2
In this captivating episode, we dive deep into the groundbreaking intersection of artificial intelligence and enzyme engineering with David Schönauer, founder and CEO of Aminoverse.From university lab benches to pioneering AI-driven enzyme discovery, David shares how his startup is transforming the biotech landscape by making enzyme development faster, more predictable, and increasingly efficient.Highlights:Discover how AI is revolutionizing enzyme prediction and design, potentially reducing development time from years to weeksLearn why high-quality wet lab data remains crucial for AI success in biotech, and how Aminoverse's unique approach combines both worldsGain insights into building a profitable biotech startup without massive venture capital funding, proving that sustainable growth is possible in deep techDavid's journey from academic researcher to biotech entrepreneur offers invaluable lessons for scientists considering the entrepreneurial path. His practical approach to combining cutting-edge AI with traditional wet lab techniques demonstrates how modern biotechnology can solve real-world problems while maintaining scientific rigor.Ready to explore the future of biotech? Listen now to learn how AI is transforming enzyme engineering and what it means for the future of sustainable technology, pharmaceuticals, and more.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!🧬 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
Nov 19, 2024 • 19min
107: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 1
Ever wondered how scientists find the perfect enzyme among billions of possibilities? In this fascinating episode of the Smart Biotech Scientist podcast, host David Brühlmann sits down with David Schönauer, CEO of Aminoverse, who's revolutionizing enzyme engineering through artificial intelligence.As a biotech entrepreneur who transformed his academic passion into a groundbreaking startup, Schönauer shares how his company is solving one of biotechnology's biggest challenges: efficiently identifying the right enzyme for specific applications, from pharmaceutical manufacturing to sustainable consumer products.Key Takeaways:Discover how Aminoverse's innovative platform navigates through more than one billion enzyme sequences to identify the most promising candidatesLearn why the perfect balance between AI-powered screening and traditional lab testing is crucial for successful enzyme engineeringUnderstand how engineered enzymes are transforming industries, from mRNA vaccine production to eco-friendly laundry detergentsWhether you're a biotech professional or simply curious about the intersection of AI and biotechnology, this episode reveals how cutting-edge technology is accelerating the discovery of nature's molecular workers.Ready to explore the future of enzyme engineering? Tune in now to hear how AI is transforming biotech innovation, one enzyme at a time.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!Support the show
Nov 14, 2024 • 20min
106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer - Part 2
In this insightful episode, Technical Development Leader at Flagship Pioneering Oliver Kraemer reveals why developing Advanced Therapy Medicinal Products (ATMPs) require a fundamental shift in thinking from traditional biologics development.Drawing from his extensive experience across Boehringer Ingelheim, Sanofi, and BMS, Kraemer challenges conventional wisdom about process development timing and demonstrates why early integration of process considerations is crucial for ATMP success.You will learn:Rethink Development Timing: Learn why incorporating process development earlier in ATMP programs dramatically reduces failure rates and prevents costly repetitionMaster Complexity: Understand the unique challenges of cell therapy development, including biological fitness and the critical interplay between cell lines, media, and processesNavigate Cost Implications: Discover strategies for managing the unexpectedly high development costs of ATMPs and making informed early decisions that impact commercial successReady to transform your approach to ATMP development? Join us for this must-listen episode as we demystify the path from bench to bedside in cell and gene therapy.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Overwhelmed by complex CGT development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving cell and gene therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
Nov 12, 2024 • 22min
105: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer - Part 1
In this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering.Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about automation in cell and gene therapy while illuminating the crucial differences between biologics and ATMPs.Key Takeaways for Biotech Scientists:Discover why automation isn't the ultimate solution for advancing CGT development right now, and what this means for your process development strategyLearn how ATMP development requires a fundamental rethinking of the traditional research-to-development pipelineUnderstand the critical early-stage decisions in cell therapy development that can make or break your project timelineJoin us as Oliver shares invaluable insights from his journey from traditional biologics to cutting-edge cell therapies, including both iPSC-derived and donor-derived approaches. Whether you're a bioprocess developer, cell therapy researcher, or biotech professional, this episode offers practical wisdom for navigating the complex landscape of ATMP development.Ready to transform your understanding of cell therapy development? Listen now to gain insights that could save you months or even years in your development timeline.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Overwhelmed by complex CGT development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving cell and gene therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
Nov 7, 2024 • 17min
104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa - Part 2
Want to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing.Sigma shares game-changing insights into accelerating biologics development without compromising quality. She also unveils how KBI is leveraging AI and machine learning to revolutionize everything from protein sequence analysis to formulation development.Key Takeaways:Learn how to master the art of seamless tech transferDiscover how to slash development timelines using innovative cell line technology and parallel processingLearn how AI and machine learning are transforming CDMO operations, from predicting developability challenges to automating lab processesReady to transform your bioprocess development journey? Tune in to hear Sigma's vision for the future of CDMOs and get actionable insights for your next project.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.comSupport the show
Nov 5, 2024 • 26min
103: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa - Part 1
In this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.Key Takeaways:Why harvest steps deserve more attention in bioprocess developmentThe truth about one-stop-shop CDMOs versus specialized partnersCritical factors in cell line and media selection that impact long-term successSigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment, not just technical capabilities. She reveals that while one-stop shops seem convenient, partnering with specialized CDMOs who excel in specific areas often yields better results - as long as there's strong project coordination.Whether you're a startup navigating your first CDMO relationship or an established biotech company looking to optimize your partnerships, this episode provides actionable insights for making informed decisions that will impact your project's success for years to come.Listen now to transform your approach to CDMO selection and avoid costly pitfalls in your bioprocess development journey.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics 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
Oct 31, 2024 • 15min
102: PAT Revolution: Decoding Your Bioprocess Like Never Before with Katharina Dahlmann - Part 2
Struggling to unravel the complexities of your bioprocess? Prepare for a paradigm shift as we dive into the world of Process Analytical Technology (PAT) with Katharina Dahlmann who is Application and PAT Expert at Hamilton.This eye-opening episode dissects how PAT is redefining biologics manufacturing, balancing its immense potential against real-world implementation hurdles. Katharina navigates us through the intricate journey of scaling up, from micro-bioreactors to large-scale bioreactors, unveiling the hidden gems of early PAT adoption. Whether you're a startup scientist or a seasoned biotech veteran, this episode is packed with insights to elevate your bioprocessing game.Tune in to uncover:Strategies for overcoming PAT implementation challengesExpert tips on scaling up your processes with confidenceA fresh perspective on cross-disciplinary collaboration in biotechDon't let bioprocess complexity hold you back – listen now and harness the power of PAT to decode your processes like never before!Connect with Katharina Dahlmann:LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180Hamilton: https://www.hamiltoncompany.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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.comSupport the show
Oct 29, 2024 • 25min
101: PAT Revolution: Decoding Your Bioprocess Like Never Before with Katharina Dahlmann - Part 1
Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT).Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell behavior and process dynamics. Katharina challenges conventional wisdom, revealing that what we think we know about our processes may just be the tip of the iceberg. Learn how combining multiple PAT signals can extract meaningful knowledge, leading to more reproducible and efficient processes.You will gain valuable insights on:Leveraging PAT to optimize feeding strategies and reduce process timeBalancing inline and offline measurements for comprehensive process understandingThe future of PAT, including self-evaluating sensors and data modelingReady to take your bioprocessing game to the next level? Tune in now and transform your approach to bioprocess monitoring and control!Connect with Katharina Dahlmann:LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180Hamilton: https://www.hamiltoncompany.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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
Oct 24, 2024 • 18min
100: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl - Part 2
Imagine predicting your bioprocess outcomes as easily as checking the weather forecast. Sound impossible? Not anymore. In this insightful episode, we dive deep into the world of digital twins and process models with Fabian Feidl, co-founder and CTO of DataHow.Discover how these cutting-edge tools are reshaping the biotech landscape, from simplifying complex processes to enabling personalized medicine. Fabian shares invaluable insights on implementing data-driven approaches, even for smaller companies with limited resources.Key takeaways:Learn how to start small and build powerful process models that drive real resultsDiscover the game-changing potential of combining AI with bioprocess expertiseExplore the future of personalized medicine through advanced data analyticsReady to revolutionize your biotech workflow? Tune in now and unlock the secrets to smarter, more efficient bioprocessing!Connect with Fabian Feidl:LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3DataHow: https://datahow.chNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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.comSupport the show
Oct 22, 2024 • 22min
99: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl - Part 1
Are you ready to decode the future of bioprocessing? In this eye-opening episode, we dive deep into the world of digital bioprocess development with Fabian Feidl, co-founder and CTO of DataHow.Discover how cutting-edge process models are transforming the biotech industry, bridging the gap between raw data and actionable insights.Key takeaways:Learn how process models can streamline development, reduce costs, and accelerate time-to-market for groundbreaking therapies.Explore the game-changing potential of personalized medicine through predictive modeling in CAR T-cell therapy.Uncover strategies to overcome organizational and technological barriers in adopting digital technologies for bioprocessing.From optimizing experimental design to enabling data-driven decision-making, this episode is packed with invaluable insights for biotech scientists and leaders. Tune in now to unlock the future of bioprocessing and take your research to the next level!Connect with Fabian Feidl:LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3DataHow: https://datahow.chNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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.comSupport the show
