009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
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How to Manage and Document Changes to CMC
As you go toward commercialization, the regulatory expectations in all these areas become much more rigorous. We intentionally do things a little bit wrong to see how much of an impact there is. By the time we get to commercial manufacturing, you try to understand things in such detail that you can say with a degree of confidence, we talk about what's an edge of failure. And so we're always trying to keep a critical assessment of what's going on and monitoring for those unexpected changes.
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