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
168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2
The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism.
In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare’s Global Analytical Development. Abhijeet has spent years on the front lines of digital transformation in the biotech sector, and his current mission: implementing generative AI for regulatory guideline monitoring, without giving the quality team a collective heart attack. He offers a no-nonsense roadmap for biotech leaders looking to streamline compliance, harness AI potential, and future-proof their operations.
Here are three reasons you should hit play on this episode:
- From Proof of Concept to Real-World Implementation: Discover how Abhijeet’s team moved beyond early excitement to tackle regulatory, IT, and data privacy requirements, carving a safe and compliant path for bringing generative AI tools into GxP and GMP-adjacent workflows.
- Human-in-the-Loop Isn’t Optional: Learn why user training, prompt engineering, and close collaboration between scientists and AI are essential for extracting meaningful (and accurate) insights, especially in environments where routine and regulation reign supreme.
- ROI and Regulation - The Balancing Act: Hear candid perspectives on measuring the return on investment for new digital tools, addressing skeptics closer to manufacturing, and why the real game-changer might just be a community-driven, industry-wide approach to regulatory acceptance.
Wondering how to unlock GenAI’s full potential - or just avoid the common pitfalls? Dive into this episode for practical strategies, cautionary tales, and actionable insights from someone who’s actually navigated the compliance minefield.
Bring AI into your pipeline with confidence, clarity, and compliance.
Connect with Abhijeet Satwekar:
LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar
Next step:
Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/call
Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech