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
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
Oct 1, 2024 • 26min
93: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer - Part 1
Discover how a failed optometry dream led Benjamin McLeod to become a leading voice in cell and gene therapy. In this eye-opening episode, Ben, who is a Cell & Gene Therapy Segment Lead at NanoMosaic, shares his unconventional path from lab work to LinkedIn stardom, revealing how he bridges the gap between R&D and marketing in biotech.Learn how Ben's weekly science memes evolved into valuable content that attracts both lab techs and CEOs alike.Key takeaways:Gain insider tips on communicating complex science effectivelyLearn how to leverage social media to build industry credibilityDiscover the power of continuous learning in fast-paced biotech fieldsWhether you're a seasoned scientist or biotech enthusiast, this episode offers invaluable insights into the art of scientific communication. Tune in now to transform your approach to biotech development and communicating science.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.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
Sep 26, 2024 • 16min
92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger - Part 2
Ever wondered why your perfectly optimized lab process falls apart at industrial scale?Mass transfer experts Lars Puiman and Rik Volger from the University of Delft reveal the hidden world of oxygen transfer and aeration that can make or break your production.Dive into the crucial differences between lab-scale and industrial-scale bioreactors, and discover why your DO sensor might be fooling you. Learn how CFD simulations and innovative downscaling techniques can revolutionize your scale-up strategy.In this episode, you'll gain:Insider tips for predicting and managing concentration gradients in large-scale reactorsCutting-edge methods to measure kLa accurately in industrial settingsStrategies to leverage microfluidics for cost-effective process developmentFrom the basics of bubble behavior to the latest in AI and machine learning, this episode is packed with practical insights to enhance your bioprocess efficiency and product quality. Don't miss out on these game-changing mass transfer secrets – tune in now and take your bioprocessing skills to the next level!Connect with our guests:Lars Puiman: https://www.linkedin.com/in/larspuimanRik Volger: https://www.linkedin.com/in/rikvolgerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentAdditional Resources:Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamicsRead the review paper at https://doi.org/10.1016/j.bej.2023.109124Support the show
Sep 24, 2024 • 17min
91: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger - Part 1
Unlock the mysteries of oxygen transfer in bioreactors with mass transfer experts Lars Puiman and Rik Volger from the University of Delft. In this eye-opening episode, dive deep into the crucial world of kLa (oxygen mass transfer coefficient) and its impact on bioprocess scale-up.Discover why understanding kLa is essential for optimizing cell growth and product formation in bioreactors. Learn practical strategies to enhance oxygen transfer, from manipulating bubble size to leveraging unexpected allies like ethanol. Our experts reveal:How to increase mass transfer efficiency without breaking the bankThe surprising effects of broth composition on oxygen transfer ratesCutting-edge sparger technologies for optimal aerationWhether you're a seasoned bioprocess engineer or a curious scientist, this episode will revolutionize your approach to oxygen transfer in bioprocessing.Don't miss these game-changing insights – tune in now!Connect with our guests:Lars Puiman: https://www.linkedin.com/in/larspuimanRik Volger: https://www.linkedin.com/in/rikvolgerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentAdditional Resources:Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamicsRead the review paper at https://doi.org/10.1016/j.bej.2023.109124Support the show
Sep 19, 2024 • 27min
90: Scale-Up Secrets: Cracking the Code of AAV Production with Ahmed Youssef - Part 2
Dive into the cutting-edge world of gene therapy as we unravel the complexities of AAV production. In this insightful episode, Ahmed Youssef, a seasoned AAV expert and Senior Process Development Manager at Ascend, explains how you can navigate the complex world of AAV scale-up and learn why thinking outside the box is crucial for success.Key takeaways:Leverage early expert advice to ensure your therapeutic's long-term viabilityExplore innovative technologies like doggy bone DNA to reduce impuritiesGain insights from industry pioneers to revolutionize your AAV production processFrom plasmid alternatives to cutting-edge CDMO strategies, this episode is packed with game-changing information. Don't miss out on these invaluable scale-up secrets that could transform your gene therapy projects.Tune in now and take your AAV production skills to the next level!Connect with Ahmed Youssef:LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssefAscend: https://www.ascend-adv.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.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
Sep 17, 2024 • 20min
89: Scale-Up Secrets: Cracking the Code of AAV Production with Ahmed Youssef - Part 1
Unlock the mysteries of AAV manufacturing in this eye-opening episode! Ahmed, a seasoned AAV expert and Senior Process Development Manager at Ascend, reveals insider strategies for biotech scientists navigating the complex world of gene therapy production.Discover why quality is the cornerstone of successful AAV development and how to avoid costly missteps in the journey from lab to clinic.Key takeaways:Learn to design a robust AAV manufacturing process that stands up to regulatory scrutinyMaster the art of balancing yield and quality for economically viable productionGain insights into cutting-edge analytical tools that ensure your AAV's efficacyFrom cell line selection to plasmid optimization, Ahmed breaks down the critical factors that can make or break your AAV project. Whether you're a biotech novice or a seasoned pro, this episode is packed with actionable advice to elevate your gene therapy game.Ready to revolutionize your approach to AAV production? Tune in now!Connect with Ahmed Youssef:LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssefAscend: https://www.ascend-adv.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
Sep 12, 2024 • 17min
88: The Swiss Army Knife of Biotech: Unleashing the Power of Fractional Expertise
Unlock the secret weapon of biotech success! In this eye-opening episode, host David Brühlmann reveals how fractional CTOs are revolutionizing drug development, inspired by Michael Jordan's approach to greatness. Learn how this innovative strategy can slash timelines, mitigate risks, and give your biotech company a competitive edge.Discover the game-changing benefits of fractional expertise:Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.Slash costs while tapping into C-level strategic guidance for critical growth phases.Accelerate business development through valuable industry connections and insights.Ready to transform your biotech journey? Tune in to explore how harnessing fractional expertise could be the catalyst your company needs.Don't miss this opportunity to level up your drug development game – listen now and stay ahead in the fast-paced world of biotech innovation!Next Steps:Schedule your free call at https://bruehlmann-consulting.com/assessment to discover how you can develop biologics better, faster, at a fraction of the cost with our Fractional CTO services.Support the show
Sep 10, 2024 • 17min
87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches
Unlock the secrets of successful bioprocess development with host David Brühlmann as he shares hard-won lessons from his 15+ years of experience leading technology transfers and technology innovation projects.Discover why prioritizing process development is crucial for transforming groundbreaking science into life-changing therapies. In this eye-opening episode, you'll learn:How to avoid costly mistakes in technology transfer and scale-up, saving you time and resourcesStrategies for balancing investor expectations with regulatory hurdles, keeping your project on trackTips for building a robust risk management strategy that impresses investors and navigates challengesFrom selecting the right cell lines to mastering the delicate dance of speed and quality, David unveils the hidden pitfalls that can derail even the most promising biotech innovations.Whether you're a seasoned scientist or a curious entrepreneur, this episode is packed with actionable insights to supercharge your bioprocess development. Don't miss out – tune in now and take your biotech game to the next level!Next 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
Sep 5, 2024 • 25min
86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 2
What if your biomanufacturing facility could run itself, optimize its own processes, and operate non-stop? This isn't science fiction – it's the cutting-edge reality Professor Massimo Morbidelli is helping to create.In this captivating episode, the bioprocessing pioneer unveils how AI, continuous manufacturing, and revolutionary machine learning techniques are transforming the industry landscape.As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.Discover how transfer learning is revolutionizing process development across molecules and scales, dramatically reducing time-to-market for new biologics. Learn why the integration of computer science and biology is crucial for staying competitive in the rapidly evolving biopharma landscape.You will gain invaluable insights onSlashing development costs,Maximizing productivity through 24/7 operationsLeveraging interdisciplinary knowledge to solve complex bioprocessing challengesAll are essential skills for thriving in the next era of biomanufacturing.Tune in now and revolutionize your approach to biopharma innovation!Connect with Massimo Morbidelli:Email: massimo “dot” morbidelli “at” polimi “dot” itNext 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? Contact 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
Sep 3, 2024 • 26min
85: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 1
Imagine a world where biologic drugs are produced faster, cheaper, and with unprecedented precision.In this episode, we dive into that future with Professor Massimo Morbidelli, a trailblazer in bioprocessing innovation. As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.From his groundbreaking work in continuous chromatography to spearheading AI-driven manufacturing, Morbidelli's 25-year journey has reshaped the biotech landscape.Discover how initial industry skepticism transformed into widespread adoption of continuous processing and machine learning. Prof. Morbidelli shares insights on his current project: a fully automated, end-to-end manufacturing process for plasmid DNA production.You will gain invaluable insights into:The evolution of continuous bioprocessing and its impact on productivity and yieldHow digitalization and machine learning are optimizing process development and manufacturingThe potential of transfer learning to dramatically reduce time-to-market for new biologicsDon't miss this opportunity to learn from a true visionary in the field.Tune in now to unlock the secrets of next-generation biomanufacturing and stay ahead of the curve in this rapidly evolving industry.Connect with Massimo Morbidelli:Email: massimo “dot” morbidelli “at” polimi “dot” itNext 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? Contact 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
