Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.
Next Steps:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2
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In 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 and microbial cells should be segregated to ensure safety.
- Early Engagement with Regulatory Agencies: Don’t wait until everything is finalized before consulting with regulatory bodies. Engaging them early can ensure your plans align with their requirements and might even spark valuable advice you hadn’t considered.
- Understand and Plan Your Product Journey: Have a clear vision of your final product from the start, and plan backwards. This approach ensures all supporting processes are adequately addressed, saving time and preventing costly mistakes down the line.
Ultimately, successful biologics development hinges on thorough understanding and strategic planning. This includes comprehensive risk assessments, early regulatory engagement, and a commitment to continuous training and facility validation.
Rivka's insights offer a roadmap for navigating this complex landscape, aiming to deliver groundbreaking therapies with precision and compliance. By following these expert strategies, biotech professionals can streamline their processes, avoid common pitfalls, and ensure the successful introduction of their products to the market.
Connect with Rivka Zaibel:
LinkedIn: www.linkedin.com/in/rivka-zaibel/
ADRES - Advanced Regulatory Services Ltd.: www.adres.bio
Email: tanya@adres.bio
Next step:
Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call
Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech