

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

May 16, 2024 • 19min
54: Bionic Bioreactors: The Key to Stress-Free Cell Cultivation w/ Patrick Bongartz - Part 2
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

May 14, 2024 • 18min
53: Bionic Bioreactors: The Key to Stress-Free Cell Cultivation w/ Patrick Bongartz - Part 1
How can you provide stress-free cultivation conditions to achieve higher cell concentrations and quality? In a nutshell, bionic bioreactors and thus change bubble-free gas exchange change the game.Join us as we delve into the future of biotech with our guest, Patrick Bongartz, CEO of BioThrust and an expert in innovative bioreactor design.Key Highlights:Unveil the groundbreaking "artificial lung," a marvel of engineering that decouples mixing and gas transfer, enabling stress-free cell growth at unprecedented densities.From scaling issues to cell sensitivity, discover the hurdles that demand ingenious solutions.Explore the critical factors when handling sensitive cell types driving bioreactor evolution.Discover how bionic bioreactors are paving the way for a stress-free future in cell cultivation.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

May 9, 2024 • 27min
52: Unraveling the Complexity of Commercializing Cell and Gene Therapies w/ Wajiha Ali - Part 2
Does the process of commercializing cell and gene therapies seem complex and unclear to you?Dive deep into the groundbreaking world of cell and gene therapies with our guest, Wajiha Ali, a strategy expert who believes in bridging the gap between research and commercialization with data, as we unravel the complexities of bringing life-saving therapies to patients.From cutting-edge technologies to innovative collaboration models, we explore the future landscape of these transformative treatments.You’ll get:An understanding of how partnerships between academic centers, pharma companies, and regulators can decrease development costs and simplify commercialization, resulting in wider accessibility.An investigation into how data analytics, AI, and machine learning can transform supply chains, target selection, commercialization strategies, and regulatory frameworks.A discovery of new methods for equitable therapy access, such as outcome-based pricing, local manufacturing, and the growing role of digital platforms in patient advocacy.Join us on this insightful journey into the future of cell and gene therapies.Connect with Wajiha Ali:LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454X (Twitter): https://twitter.com/WajihaaliNext Step:Develop biologics and cell & gene therapies with peace of mind. Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment🧬 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

May 7, 2024 • 19min
51: Unraveling the Complexity of Commercializing Cell and Gene Therapies w/ Wajiha Ali - Part 1
Are you finding the path to commercializing cell and gene therapies complex and uncertain?Join us as we explore this intricate landscape with our guest, Wajiha Ali. As a strategy expert who believes in bridging the gap between research and commericalization with data who she will guide us through the challenges, victories, and vital strategies for successfully bringing these cutting-edge therapies to market.Key Highlights:Discover the amplified complexity of cell and gene therapies, from patient referral hurdles to manufacturing site regulations.Explore the crucial commercialization strategies, infrastructure requirements, and the delicate balance between innovation and necessity.Unveil the regulatory scrutiny and stakeholder management intricacies, paving the way for safer, more accessible therapies.Tune in as we navigate the journey from scientific breakthroughs to real-world application, unraveling the complexities shaping the future of healthcare.Connect with Wajiha Ali:LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454X (Twitter): https://twitter.com/WajihaaliNext Step: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

May 2, 2024 • 11min
50: Decode Bioprocess Success: The Art of Stakeholder Management - Part 2
In the second part of "Decode Bioprocess Success: The Art of Stakeholder Management," we delve deeper into the strategies for effective stakeholder management in bioprocess development.Through a step-by-step approach, we explore how to identify, classify, and engage with stakeholders to ensure project success.Key highlights:Learn how to create a stakeholder management plan tailored to the unique needs and interests of each stakeholder group.Discover the power interest grid, a valuable tool for categorizing stakeholders based on their level of influence and interest in the project.Gain insights into developing communication plans that align with stakeholders' preferences and needs.Join us as we uncover the art of stakeholder management and its transformative impact on bioprocess development success. Don't miss out on this episode filled with practical advice and actionable strategies for mastering stakeholder engagement in bioprocess projects.Next Step:Boost your bioprocess strategy! Book your free assessment for success: https://bruehlmann-consulting.com/assessmentSupport the show

Apr 30, 2024 • 17min
49: Decode Bioprocess Success: The Art of Stakeholder Management - Part 1
In this episode, we embark on a journey to uncover the essential strategies for navigating stakeholder relationships in bioprocess CMC development projects.We delve into the critical role of stakeholders in bioprocess development and how their engagement can determine the success or failure of a project. Drawing from real-life experiences and insights, we explore the importance of understanding stakeholder needs, interests, and power dynamics.Discover why stakeholder management is not just a skill but an art form essential for unlocking bioprocess success. Join us as we unravel the complexities of stakeholder engagement and provide actionable tips for mastering this crucial aspect of bioprocess development.Tune in to learn how decoding the dynamics of stakeholder management can lead to triumph in bioprocess projects.Next Step:Boost your bioprocess strategy! Book your free assessment for success: https://bruehlmann-consulting.com/assessmentSupport the show

Apr 25, 2024 • 19min
48: Mastering Process Economics: Driving Down Costs in Antibody Production w/ Brian Kelley - Part 2
Unlock the secrets to cost-efficient antibody therapeutics with Brian Kelley, Senior Vice President of Process Development at VIR Biotechnology.In this illuminating episode, industry expert Brian Kelley shares invaluable insights into driving down manufacturing costs while maintaining quality and accessibility. From optimizing batch sizes to maximizing titers, discover practical strategies to streamline the process economics of antibody development.Key Takeaways:Scale Matters: Learn how economies of scale play a pivotal role in minimizing manufacturing costs, paving the way for global accessibility of life-saving therapies.Titer Triumphs: Dive deep into the significance of maximizing titers to achieve substantial reductions in batch requirements and cost of goods, revolutionizing antibody production efficiency.Focus Innovation: Gain clarity on where to direct innovation efforts, balancing established manufacturing practices with groundbreaking developments in emerging modalities like cell and gene therapies.Join us as we unravel the future landscape of antibody production, where simplicity and innovation converge to shape the next frontier of healthcare solutions. Tune in now for actionable strategies and visionary perspectives on mastering process economics in antibody therapeutics.Connect with Brian Kelley:LinkedIn: https://www.linkedin.com/in/brian-kelley-3389375Next Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show

Apr 23, 2024 • 17min
47: Mastering Process Economics: Driving Down Costs in Antibody Production w/ Brian Kelley - Part 1
Join us in this enlightening episode as we explore process economics with industry expert Brian Kelley. He is the Senior Vice President of Process Development at VIR Biotechnology.Unraveling the mysteries of cost management in antibody therapeutics, Brian sheds light on the intricate challenges faced by biotech scientists and engineers.Key Highlights:Discover the nuanced interplay between technical and cultural obstacles in process development.Navigate the labyrinth of cost drivers in antibody manufacturing, from raw materials to labor expenses.Learn the art of balancing speed, quality, and cost-effectiveness in bringing therapeutics to market.Tune in for a masterclass in maximizing efficiency and driving down costs in the dynamic landscape of biologics production.Connect with Brian Kelley:LinkedIn: https://www.linkedin.com/in/brian-kelley-3389375Next Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show

Apr 18, 2024 • 28min
46: From Lab to Table: The Science Behind Cultivated Meat w/ Petra Hanga - Part 2
Dive into the future of food with our latest episode, "From Lab to Table: The Science Behind Cultivated Meat." With our guest, Petra Hanga, a Lecturer in Biochemical Engineering at University College London and Chief Scientific Officer of Quest Meat Ltd., we unravel the secrets behind this groundbreaking technology.Key highlights:1. Discover how stem cells revolutionize the production of cultivated meat, providing a scalable solution for creating muscle, fat, and connective tissues.2. Explore the intricate balance of nutrients, growth factors, and environmental conditions crucial for maximizing cell growth and quality.3. Understand the challenges and breakthroughs in scaling up bioreactor processes for efficient meat production.Join us for an informative discussion on the cutting edge of food technology. Gain valuable insights into the process of transforming lab-grown cells into delectable dishes on your table.Don't miss out on this compelling episode!Connect with Petra Hanga:LinkedIn: https://www.linkedin.com/in/petrahanga/Twitter: @PetraHangaNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment🧬 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

Apr 16, 2024 • 14min
45: From Lab to Table: The Science Behind Cultivated Meat w/ Petra Hanga - Part 1
Dive into the fascinating world of cultivated meat with our guest, Petra Hanga, Lecturer in Biochemical Engineering – Cellular Agriculture at University College London and the Chief Scientific Officer of Quest Meat Ltd.In this episode, Petra sheds light on the intricacies of developing cultivated meat and reveals the key hurdles biotech scientists face.Highlights:Learn how scientists tackle the complexity of replicating animal meat, ensuring a truly authentic taste and texture for future meat alternatives.Gain insight into the innovative solutions shaping the future of sustainable protein sources.Discover the potential of cultivated meat to revolutionize our food system.Join us as we explore the promising landscape of cultivated meat, where science and innovation converge to shape a more sustainable future.Enjoy your listening!Connect with Petra Hanga:LinkedIn: https://www.linkedin.com/in/petrahanga/Twitter: @PetraHangaNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show