With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.
Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development.
Thermo Fisher Scientific
4721 Emperor Blvd., Suite 200
Durham, NC 27703-8580
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