What if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document? Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to cli...
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248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2
247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1
246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 2
245: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 1
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