Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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 clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I 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
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1
In 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.
Here are three key takeaways from this episode:
- Prioritize CMC Development Early: CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey.
- Understand Regulatory Differences: Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively.
- Leverage Existing Resources: Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach.
For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently.
In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive!
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