Bacterial Therapy: Modulation of the Microbiome With Dr. Bernat Olle
Business Of Biotech
00:00
The Manufacturing and Regulation Environment for Bacterial Therapeutics
I'm curious about manufacturing and regulatory, the manufacturing regulatory environment for bacterial therapeutics. How, how does the manufacturing process look different than traditional biologics or the same. And then if you can kind of go from there to the, the, the regulatory waters that you've had to navigate as you as you moved forward. Is it uncharted is it entirely uncharted water that you know the FDA seeing for the first time or is there some precedent there as well?
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