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 23, 2023 • 13min
08: Unveiling the Power of Microcarriers: Scaling Up Adherent Cell Cultures in Bioprocessing w/ Payar Radfar - Part 2
In the second part of our insightful interview with Payar Radfar, CEO of Smart MCs, we delve into the practical steps of developing adherence cell cultures for bioprocessing scalability.Payar emphasizes the critical need for patience and a methodical approach, recounting how many clients rush into large-scale cultures prematurely. The key takeaways include:1. Start Small, Stay Patient: Begin with small cultures and test various microcarriers. Patience is crucial; rushing can lead to ambiguous results and hinder long-term success. 2. Role of Modeling: Payar discusses the potential of AI modeling in scaling up processes. While AI can save time, he emphasizes the importance of a cautious, step-by-step approach. 3. Avoid Pitfalls: Highlighting the diverse nature of cell types, microcarriers, and bioreactors, Payar warns against assuming uniformity. Each component plays a crucial role, requiring careful consideration and gradual adjustments.Join us as we explore future trends in bioprocessing, where Payar anticipates breakthroughs in media formulation and the use of novel technologies like microfluidics. Discover the broad applications beyond cellular therapies and cultivated meat, reaching into vaccine production and other cell-dependent fields.Tune in now to gain invaluable insights into the dynamic world of adherence cell cultures and the promising future of bioprocessing innovation.Connect with Payar Radfar:Website: https://smartmcs.com.au/LinkedIn: linkedin.com/company/smart-mcsTwitter: twitter.com/SmartMCsPTYLTDSupport the show
Nov 21, 2023 • 16min
07: Unveiling the Power of Microcarriers: Scaling Up Adherent Cell Cultures in Bioprocessing w/ Payar Radfar - Part 1
In this episode, we explore the world of adherent cell cultures with Payar Radfar, CEO of Smart MCs. Smart MCs specializes in customized biomaterials and microfluidic solutions. Payar shares his unique journey in the biotech industry, driven by his passion for improving people's health.Key Takeaways:1. Revolutionizing Bioprocessing: Payar discusses the challenges scientists face when transitioning from lab-scale to industrial-scale production. He emphasizes the importance of a multidisciplinary approach and envisions his company playing a crucial role in simplifying and enhancing bioprocessing technologies.2. Cost Challenges in Cellular Therapies: Payar addresses the high costs associated with cellular therapies and explores the barriers to wider distribution. He highlights the role of competition and regulations in reducing costs and increasing accessibility to these therapies.3. The Power of Microcarriers: The technical discussion focuses on microcarriers and their vital role in adherent cell cultures. Payar explains how these microscopic spheres enable efficient scaling up of cell production in bioreactors, offering a glimpse into the future of bioprocessing.Are you curious about the transformative potential of microcarriers and the future of bioprocessing?Join us in this insightful conversation with Payar Radfar as we uncover the secrets behind scaling up adherent cell cultures and their profound impact on the biotech industry.Connect with Payar Radfar:Website: https://smartmcs.com.au/LinkedIn: linkedin.com/company/smart-mcsTwitter: twitter.com/SmartMCsPTYLTDSupport the show
Nov 16, 2023 • 19min
06: Hybrid Modeling: The Key to Smarter Bioprocessing w/ Michael Sokolov - Part 2
In the second part of our conversation with Michael Sokolov, the co-founder and COO of DataHow, we dive into practical insights on leveraging hybrid modeling in bioprocessing.You will discover:1. Starting Small, Dreaming Big: Even in smaller companies, you can start with a minimal number of reactors and still leverage hybrid modeling effectively. Whether it's just a few shakers or a handful of bioreactors, you can begin the journey to process improvement.2. The Power of Digital Twins: Michael sheds light on the concept of digital twins, which involves creating a real-time model of your bioprocess. It not only helps optimize the process but also enables feedback control, reducing manual operations and adapting to changes on the fly.3. Regulatory Acceptance: While the pharmaceutical industry is known for its conservatism, regulators are becoming more receptive to innovative technologies like hybrid modeling. Health authorities are encouraging the use of promising tools in process development and are not imposing specific technologies. As more companies adopt these tools and gather data on their effectiveness, they are likely to play a more prominent role in regulatory filings.Don't miss out on this insightful discussion with Michael Sokolov as he unravels the potential of hybrid modeling in bioprocessing. If you're looking to simplify and streamline your bioprocessing journey, this episode is a must-listen.Connect with Michael Sokolov:Website: www.datahow.chSupport the show
Nov 14, 2023 • 17min
05: Hybrid Modeling: The Key to Smarter Bioprocessing w/ Michael Sokolov - Part 1
In this insightful conversation, we explore how to accelerate bioprocess development and enhance manufacturing using hybrid modeling. Our guest, Michael Sokolov, COO of DataHow (a spin-off company from ETH Zurich), shares valuable insights.Discover the three major takeaways that could transform the bioprocessing industry:1. Unlocking the Power of Hybrid Modeling: Michael Sokolov introduces the revolutionary concept of hybrid modeling, which combines mechanistic knowledge with machine learning to expedite bioprocess development.2. Accelerating Process Development: Learn how hybrid modeling can speed up your bioprocessing efforts, potentially allowing you to reduce the number of experiments by 60-80%, saving valuable time and resources.3. Data-Driven Decision Making: Gain insights into how this approach enables data-driven decision making in the unpredictable world of biotech. It provides a deep understanding and empowers scientists to make informed choices.Don't miss this episode for a comprehensive guide to smarter and more efficient bioprocessing!Connect with Michael Sokolov:Website: www.datahow.chSupport the show
Nov 9, 2023 • 15min
04: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 2
In today's episode, we continue our fascinating conversation with Leonardo Sibilio, CEO of Biotech Academy and CSO at BetaPro Consulting. We delve into the pivotal role of structured training in the dynamic biotech industry.In this episode, you'll discover:- Foundation of Success: Leonardo emphasizes the importance of a strong foundation in GMP and an understanding of biotech facility operations. Whether you're an aspiring employee or a seasoned professional, a solid knowledge base in these areas is the cornerstone of a successful career.- Broaden Your Horizons: Biotech is a multifaceted industry. Leonardo advises listeners to be curious and embrace a wide range of skills. You'll thrive by gaining expertise in both upstream and downstream processes, as well as analytical methods. This adaptability is key to succeeding in today's rapidly evolving biotech landscape.- Continuous Learning: In the ever-changing world of biotech, continuous learning is vital. Leonardo recommends staying updated with technical literature, online courses, and hands-on training. To excel, it's crucial to master the practical aspects of bioreactor assembly, autoclaving, and equipment operation.Join Leonardo as he explores the exciting opportunities in biotech, and find out how to enhance your expertise.If you're passionate about biotech and eager to take your career to new heights, this episode is a must-listen! Don't miss out on the valuable insights Leonardo shares on mastering biotech scale-up. Tune in now!Connect with Leonardo Sibilio:LinkedIn: www.linkedin.com/in/leonardo-sibilio-9bb26320🧬 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 7, 2023 • 18min
02: Unlock the Power of Rational Media Design in Bioprocessing w/ Tom Fletcher - Part 2
Welcome to a fascinating Smart Biotech Scientist episode! In this conversation, we dive deep into the nuts and bolts of rational media development with our guest, Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific.Together, we explore the immense potential of Rational Media Design and how it's transforming the industry.Here are three major takeaways from this episode:1. Define Your Goals: Tom emphasizes the importance of clearly defining your bioprocessing goals. Whether it's boosting cell growth or enhancing product quality, understanding your specific needs is the first crucial step.2. Gain Process Understanding: Learn how to identify limiting factors in your process and generate hypotheses. Tom discusses how thinking through biochemical pathways and potential bottlenecks is key to achieving your goals.3. Leverage Automation: Discover the future of bioprocessing with automated, closed systems that eliminate human intervention and ensure consistent, sterile media preparation. Tom shares insights into groundbreaking innovations that simplify and streamline the process.Join us in unraveling the science behind bioprocessing and unlock the power of rational media design in this episode.Don't miss out on the knowledge that could revolutionize your bioprocessing journey!Connect with Tom Fletcher:LinkedIn: https://www.linkedin.com/in/tomfletcher2Fujifilm Irvine Scientific: https://www.irvinesci.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 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 7, 2023 • 19min
01: Unlock the Power of Rational Media Design in Bioprocessing w/ Tom Fletcher - Part 1
In this episode with Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific, we delve into the world of bioprocessing. Tom shares insights into the transformative power of rational media design.From the complexities of bioprocess development to the game-changing potential of AI, this interview is a treasure trove of knowledge for both scientists and engineers.You will learn:- Learn about the evolution of priorities during bioprocess development, from speed to reliability, and how scientists must adapt accordingly.- Discover the importance of a thoughtful, hypothesis-driven approach compared to a blind, random one, and how it can reveal valuable process knowledge.- Explore the exciting future of bioprocessing, including the role of AI and in silico models, and the importance of combining technology with human reasoning.Tune in to gain a deeper understanding of the critical role that rational media design plays in advancing the biotech industry.Connect with Tom Fletcher:LinkedIn: https://www.linkedin.com/in/tomfletcher2Fujifilm Irvine Scientific: https://www.irvinesci.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 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 7, 2023 • 19min
03: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 1
In this captivating episode, we delve into the world of biotech scale-up with the seasoned expert, Leonardo Sibilio, CSO at BetaPro Consulting and CEO of the Biotech Academy in Rome.Discover how mastering the art of biotech scale-up can transform your journey from doubt to dominance.Key Takeaways:1. Early Planning is Paramount: Leonardo emphasizes the importance of initiating the scale-up process as early as possible. Waiting until later phases can lead to challenges and hinder progress. Early planning, including characterizing the cell line and ensuring stability, is key to a seamless transition from R&D to large-scale production.2. Mindset Shift is Crucial: Successful scale-up requires a shift in mindset, especially for startups originating from academia. Transitioning from research to regulated environments demands precision, rigorous documentation, and an unwavering focus on producing life-changing medicines.3. Embrace Learning and Structured Processes: Leonardo encourages the use of structured methodologies and tools like R or Python for better data analysis and visualization. Structured documentation and reporting are critical for regulatory compliance and efficient tech transfer.Join us as we explore the challenges, pitfalls, and strategies of biotech scale-up, unlocking the secrets to mastering it without guesswork.Whether you're a seasoned professional or new to the field, this episode provides valuable insights for anyone interested in bioprocess scale-up and commercialization.Connect with Leonardo Sibilio:LinkedIn: www.linkedin.com/in/leonardo-sibilio-9bb26320🧬 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, 2023 • 3min
Biotech Simplified: Your Path to Bioprocess Mastery Unveiled (Trailer)
Are you a busy biotech scientist, trying to navigate the complex world of bioprocessing while fueling your passion for science? Join us on the Smart Biotech Scientist Podcast, where we're about to unravel the secrets to bioprocess mastery.Hosted by a seasoned biotech leader and entrepreneur with over 15 years in the industry, this podcast is your compass through the maze of challenges. Picture yourself in the lab, deadlines looming, feeling like you're solving a puzzle with missing pieces. We've been there, too.In this podcast, we simplify the journey to bioprocess mastery, providing practical solutions, deep dives into analytics, and inspiring conversations with biotech leaders. Imagine gaining insights from industry experts and belonging to a supportive community that fuels your growth.Get ready for stories that resonate, solutions that empower, and questions that pique your curiosity. Don’t miss out!►► Subscribe now, with new episodes dropping every Tuesday and Thursday.Reignite your passion for science as we tackle challenges and simplify bioprocessing together. Join us on this exciting adventure!Support the show
