Shows
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2In this episode, we explore the important steps in preparing for regulatory meetings, address the dangers of cross-contamination in biotechnology facilities, and debunk common misconceptions that could derail your CMC development strategy.As the founder and president of ADRES - Advanced Regulatory Services Ltd., Rivka Zaibel brings over 36 years of industry experience and practical strategies to help navigate the intricacies of CMC development and regulatory compliance.Here are three key takeaways:Risk Assessment is Paramount: Start risk assessments in parallel with facility design to prevent cross contamination. Remember, areas for both mammalian...2025-03-2720 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1In biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC).In this episode of the Smart Biotech Scientist, host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders.With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development.2025-03-2525 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2Dive 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 p...2024-05-3019 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation57: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 1Join 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 o...2024-05-2817 min