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
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
Jun 18, 2024 • 27min
63: Why Sound Waves Are the Future of Gene Therapy Bioreactors w/ Gabriel Dumy - Part 1
Are sound waves the key to revolutionizing gene therapy? In this groundbreaking episode, we sit down with Gabriel Dumy, CTO and Co-founder at Kolibri, a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.Gabriel shares the challenges facing modern bioproduction and unveils an exciting solution that's setting the stage for the future of gene therapy.Key Takeaways:Enhanced Cell Productivity: Discover how acoustic waves minimize shear stress, significantly boosting mammalian cell productivity and density.Versatile Bioreactor Design: Learn about a cell-agnostic technology that seamlessly adapts to various cell lines, simplifying process development.Scalable Innovation: Understand the potential of this scalable tech to maintain consistent microenvironments, paving the way for large-scale gene therapy production.Tune in to find out how acoustic waves could be the breakthrough gene therapy has been waiting for!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.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
Jun 13, 2024 • 15min
62: Magnetic Bead Technology: The New Era in Downstream Processing w/ Nils Brechmann - Part 2
Dive into the future of bioprocessing with Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, as we explore how magnetic bead technology is transforming downstream processing.MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.Key Takeaways:Streamlined Purification: Discover how magnetic beads enable simultaneous clarification and capture, boosting efficiency.Cost Savings: Learn about significant cost reductions by integrating steps and improving process economics.Scalable Solutions: Understand the potential for large-scale applications, making magnetic bead technology a versatile option for biomanufacturing.Join us for an in-depth look at the benefits and innovations of magnetic bead technology in modern bioprocessing.Connect with Nils Brechmann:LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114aMAGic BioProcessing: https://magicbioprocessing.comNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
Jun 11, 2024 • 19min
61: Magnetic Bead Technology: The New Era in Downstream Processing w/ Nils Brechmann - Part 1
Dive into the latest episode as we explore how magnetic bead technology is revolutionizing downstream processing, promising higher yields and greater purity.Our guest, Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, shares his insights on overcoming industry challenges and the future of purification. MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.Key Takeaways:Discover how magnetic beads integrate cell clarification and capture, reducing processing steps and mechanical stress.Learn about the remarkable efficiency of magnetic beads in achieving low Host Cell Protein (HCP) levels right from the start.Understand the economic benefits of this technology, from cost savings to increased throughput in large-scale facilities.Ready to elevate your bioprocessing game? Tune in now and harness the power of magnetic bead technology.Connect with Nils Brechmann:LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114aMAGic BioProcessing: https://magicbioprocessing.comNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
Jun 6, 2024 • 21min
60: Next-Generation Sequencing: Transforming Science and Medicine w/ Jonathon Hill - Part 2
Unlock the future of epigenetics and join us for an insightful conversation with Jonathon Hill as he delves into the groundbreaking world of next-generation sequencing (NGS) and its transformative impact on science and medicine. Jonathon Hill is the VP of Science and Technology and a co-founder of Wasatch BioLabs and Associate Professor of Cell Biology and Physiology at Brigham Young University.Discover how cutting-edge nanopore technology is overcoming the limitations of traditional methods and revolutionizing epigenetic research.Key Takeaways:Unparalleled Accuracy: Learn how nanopore technology achieves 99.6% accuracy in methylation calls, eliminating PCR and bisulfite conversion noise.Comprehensive Insights: Understand the benefits of whole-molecule sequencing for detailed methylation analysis, providing a clearer, more precise picture of genetic data.Future of Diagnostics: Explore the future of NGS in clinical settings, with genomic and epigenetic data integration into electronic health records guiding personalized treatments.Don't miss this episode packed with innovative insights and the future landscape of genomic technology.Connect with Jonathon Hill:LinkedIn: https://www.linkedin.com/in/jonathon-t-hillWasatch BioLabs: https://www.wasatchbiolabs.comNext Steps:Schedule your free assessment to take process development to the next level now at https://bruehlmann-consulting.com/assessmentSupport the show
Jun 4, 2024 • 17min
59: Next-Generation Sequencing: Transforming Science and Medicine w/ Jonathon Hill - Part 1
Curious about the latest advancements in next-generation sequencing (NGS) and how they are revolutionizing science and medicine?In this episode, we delve into the cutting-edge developments of NGS with our expert guest, Jonathon Hill, VP of Science and Technology and a co-founder of Wasatch BioLabs and Associate Professor of Cell Biology and Physiology at Brigham Young University, who has been at the forefront of this transformative field.Key Takeaways:Discover how NGS is empowering scientists to explore new frontiers in research with groundbreaking tools and technologies.Learn about the incredible advancements in long-read sequencing and their impact on genome assembly and understanding complex diseases.Understand how NGS is unlocking the potential of epigenetics, revolutionizing drug development, and enhancing diagnostic accuracy for personalized medicine.Join us to get an insider's view on how NGS is not only changing the landscape of research but also making a profound impact on human health. Don't miss this informative conversation with a leading expert in the field!Connect with Jonathon Hill:LinkedIn: https://www.linkedin.com/in/jonathon-t-hillWasatch BioLabs: https://www.wasatchbiolabs.comNext Steps:Schedule your free assessment to take process development to the next level now at https://bruehlmann-consulting.com/assessmentSupport the show
May 30, 2024 • 19min
58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2
Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.Key Takeaways:Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring product consistency—a game-changer in the industry's quest for reliability.By adopting a phased approach to process development rooted in QbD, companies can streamline experimentation, minimize resource expenditure, and accelerate time-to-market, amplifying efficiency by up to 40%.Embracing innovation, such as machine learning and digitalization, holds the key to unlocking new horizons in CMC development, paving the way for a future where creativity and regulatory compliance converge seamlessly.Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.Connect with Matthias Müllner:LinkedIn: https://www.linkedin.com/in/matthias-muellnerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 28, 2024 • 17min
57: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 1
Join us for an insightful episode as we dive into the world of bioprocess CMC development strategies with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Matthias shares his wealth of knowledge on avoiding common pitfalls in developing robust Chemistry, Manufacturing, and Controls (CMC) strategies. He also emphasizes the critical elements that ensure your biotech product's success.Key Takeaways:Start Strong: Establishing a comprehensive CMC plan early can prevent costly and time-consuming issues later.Leverage Expertise: Bringing in external CMC consultants early on can bridge knowledge gaps and streamline the development process.Build Internally: Gradually develop in-house CMC capabilities to enhance long-term project viability and attract investor confidence.Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.Connect with Matthias Müllner:LinkedIn: https://www.linkedin.com/in/matthias-muellnerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 23, 2024 • 15min
56: Cultivated Meat: A Promising Future or an Inevitable Bubble? w/ Steven Lang - Part 2
Is cultivated meat the food of tomorrow or just a passing trend? In this episode, we dive deep with Steven Lang, an expert in the field of cultivated meat. Steven sheds light on the intricate process of creating meat in the lab, the challenges faced, and the potential future of this innovative industry.Key Takeaways:Precision in Analytics: Discover how cutting-edge sensory analytics are crucial for developing cultivated meat that mimics traditional meat's texture and taste.Regulatory Innovation: Learn why the regulatory landscape for cultivated meat is set to revolutionize, benefiting not just food tech but also the biopharmaceutical industry.Future Prospects: Understand the potential pitfalls and the exciting innovations on the horizon, making cultivated meat a game-changer for food and biotech sectors.Tune in to explore whether cultivated meat is the future we’ve been waiting for or just a bubble waiting to burst.Connect with Steven Lang:LinkedIn: https://www.linkedin.com/in/steven-lang-b003406Next Step:Don't miss out on boosting your bioprocess development strategy! Schedule your complimentary assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 21, 2024 • 23min
55: Cultivated Meat: A Promising Future or an Inevitable Bubble? /w Steven Lang - Part 1
How can you create an environment suitable for shear-stress-sensitive cells that results in higher cell concentrations and superior quality? Essentially, bionic bioreactors revolutionize this process, changing the game rules with their ability to facilitate bubble-free gas exchange.Join us in this episode as we unravel the groundbreaking innovations in bioreactor technology with our guest, Patrick Bongartz, CEO of BioThrust and the visionary mind behind stress-free cell cultivation.Key Highlights:Discover how bionic bioreactors defy conventional limitations, doubling cell densities even in sensitive cultures like insect cells, promising a paradigm shift in bioproduction efficiency.Unveil the game-changing membrane stirrer technology that not only enhances oxygen transfer but also facilitates precise pH control, revolutionizing process optimization and scalability.Embrace the challenge of disrupting conservative mindsets in the biotech industry.Embark on a journey of scientific breakthroughs and entrepreneurial resilience in this episode.Connect with Patrick Bongartz:Website: https://biothrust.deLinkedin BioThrust: https://www.linkedin.com/company/biothrust-deInstagram: https://www.instagram.com/biothrustPatrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/Next Step: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/assessmentSupport the show
