Compounding FDA Process Improvement Vaccines 
ISPE
SEPTEMBER 11, 2023
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” New Project: Evolutive Vaccines Facility for Sanofi.”
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Although they have been historically overlooked as a key element, raw materials are a critical component at every stage of the drug manufacturing processes. Burke, PhD. 1 September 2022.
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