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009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle

Business Of Biotech

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Scalping Scalp: Common Pitfalls and Problems

There are a few things that can come up as you try to scale up. Some of the sort of some of the steps that you would do in a small scale, like in a test tube or in a flask on in your laboratory bench, you can't replicate those mechanics if you're working in thousands of liter volumes. If in biologics, we're dealing with cells and cells are growing and cells are very particular to their environment. And so the some of the things that cells will do on a benchtop, they won't do or they will do very differently when you're in a 10,000 liter tank.

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