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
247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1
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When drug safety fails, patients and entire markets pay the price. Understanding your CMC isn't just compliance — it's the line between therapeutic promise and product recall.
Ron Najafi has lived that reality firsthand. As founder of NovaBay Pharmaceuticals and Emery Pharma, he spent decades building companies at the intersection of analytical chemistry and drug development. His investigation into nitrosamine contamination in ranitidine — which led the FDA to formally validate Emery Pharma's findings — remains one of the most consequential episodes in recent pharmaceutical quality history.
In Part 1, Ron traces the scientific and entrepreneurial path that led him there, and shares what CMC teams working in drug development need to understand about impurity risk before it becomes a regulatory crisis.
Episode highlights:
- Early academic experiences and inspirations that Ron Najafi to a science career (05:46)
- Challenges and milestones in building companies like CP Lab Safety and NovaBay Pharmaceuticals (07:59)
- The invention and impact of the ECO Funnel® on lab safety and environmental responsibility (12:01)
- The formation of Emery Pharma following industry setbacks and lessons in adaptation (17:03)
- The fundamentals of impurity risk analysis, especially nitrosamine contamination in pharmaceuticals (20:56)
- The ranitidine (Zantac) NDMA discovery, its investigation, and consequences for drug regulation (23:33)
- Common sources of nitrosamine and practical advice for bioprocess risk management (27:51)
- Differences in impurity risk between small molecule and biologic drug processes (28:03)
- The necessity and regulatory expectation of impurity and leachable/extractable analysis (30:07)
Smart insight:
One of Ron's clients conducted a superficial nitrosamine risk assessment, proceeded to manufacturing, and spent approximately $6 million producing three batches. At final FDA-required testing, NDMA came back at 11,000 nanograms per pill against an acceptable daily intake limit of 96 nanograms. The batches were unusable.
A thorough risk assessment run earlier would have cost a fraction of that. If you are developing a drug with secondary or tertiary amines in your process and have not yet conducted a formal nitrosamine risk assessment, that is the one action to take after listening to this episode.
If this topic resonates with you, here are a few related episodes on building strong CMC foundations and avoiding costly development mistakes:
- Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann
- Episodes 203 - 204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith
- Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development
- Episodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)
- Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
- Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene Lee
Connect with Ron Najafi:
LinkedIn: www.linkedin.com/in/ronnajafi
Emery Pharma: www.emerypharma.com