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
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.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
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.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
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
Oct 17, 2024 • 18min
98: The Biomanufacturing Revolution: Bringing Game-changing Products to Market with James Ryall - Part 2
Are you ready to dive into the cutting-edge world of biomanufacturing? In this episode, strategic consultant James Ryall unveils the staggering potential of bio-based products to revolutionize industries. From cultured meat to human breast milk, discover how cells are becoming the ultimate manufacturing facilities.James shares invaluable insights on scaling challenges, regulatory hurdles, and the critical importance of early preparation for biotech startups. Learn why biomanufacturing is poised to transform up to 60% of consumer goods and how to stay ahead in this rapidly evolving field.Gain expert strategies to:Navigate scaling and regulatory challenges with confidenceCreate bio-based products that outperform traditional alternativesTap into the immense opportunities in non-clinical biomanufacturingWhether you're a seasoned bioprocessing expert or a curious entrepreneur, this episode will ignite your passion for the biotech revolution. Tune in now and discover how to ride the wave of biomanufacturing innovation!Connect with James Ryall:LinkedIn: https://www.linkedin.com/in/james-ryallWebsite: https://www.jamesryall.comNext Steps:Wondering how to develop biologics with clarity and precision? 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.comSupport the show
Oct 15, 2024 • 26min
97: The Biomanufacturing Revolution: Bringing Game-changing Products to Market with James Ryall - Part 1
In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and industry.Discover how he's now helping biotech startups align their technical strategies with commercial outcomes, accelerating their path to market.You will gain invaluable insights on:Navigating the transition from academia to industryScaling cell production from lab quantities to industrial volumesIdentifying and pivoting to the right target market for biotech innovationsDon't miss this eye-opening discussion on simplifying bioprocessing and bringing game-changing products to life. Tune in now to supercharge your biotech career!Connect with James Ryall:LinkedIn: https://www.linkedin.com/in/james-ryallWebsite: https://www.jamesryall.comNext Steps:Wondering how to develop biologics with clarity and precision? 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
Oct 10, 2024 • 20min
96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic - Part 2
Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma.Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's no longer optional but essential for success.Key takeaways:Leverage AI to streamline experiments, reduce costs, and accelerate your path to marketGain insights into emerging AI technologies reshaping biopharma's futureLearn practical steps to integrate AI into your workflow, even with limited resourcesDon't miss this opportunity to stay ahead of the curve and unlock the full potential of your biotech projects. Tune in now to empower your scientific journey and simplify complex bioprocessing challenges with AI-driven solutions.Connect with Belma Alispahic:LinkedIn: https://www.linkedin.com/in/balispahicAnalysis Mode: https://analysismode.comNext Steps:Wondering how to develop biologics with clarity and precision? 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.comSupport the show
Oct 8, 2024 • 21min
95: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic - Part 1
Is AI the secret weapon biotech scientists have been waiting for? In this eye-opening episode, we dive deep into the world of AI-driven bioprocess development with Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode. Discover how AI is transforming the biotech landscape, from reducing downtime by 50% to unlocking unprecedented levels of precision in process optimization.Key takeaways:Learn how AI can slash experiment time by up to 80%, saving you valuable resourcesUncover the power of digital twins in fine-tuning your bioprocesses with unparalleled accuracyGain insights on overcoming data challenges to harness AI's full potential in your labDon't miss this game-changing discussion that could revolutionize your approach to bioprocess development. Tune in now and stay ahead of the curve in the rapidly evolving world of biotech!Connect with Belma Alispahic:LinkedIn: https://www.linkedin.com/in/balispahicAnalysis Mode: https://analysismode.comNext Steps:Wondering how to develop biologics with clarity and precision? 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.comSupport the show
Oct 3, 2024 • 20min
94: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer - Part 2
In this electrifying episode, we dive deep into the future of biotech with biotech influencer Benjamin McLeod. From quantum AI mapping cellular interactions to the game-changing potential of process analytical technology, Ben, who is also a Cell & Gene Therapy Segment Lead at NanoMosaic, unveils how artificial intelligence is set to transform the cell and gene therapy landscape.Discover why LinkedIn is becoming the new frontier for biotech networking and career advancement. Learn how combining AI with PAT could slash production costs and boost yields in ways you've never imagined.You will gain invaluable insights on:Leveraging AI to optimize bioprocesses and reduce costsThe evolving landscape of viral and non-viral gene therapiesStrategies for breaking into the cell and gene therapy fieldDon't miss this opportunity to stay ahead of the curve in biotech innovation. Tune in now and revolutionize your approach to bioprocessing!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.comSupport the show
