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
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 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
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 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
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 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
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 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
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
