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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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. Nature Communications 12, no. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” 3 (2020):e2970.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. The use of structured content and data management in CMC regulatory submissions could potentially provide a direct link to proactively manage risks in the supply chain and communicate with regulators.