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Considerations for a Decentralized Manufacturing Paradigm

ISPE

September 2004. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. Journal of Pharmaceutical Sciences 111, no.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. 6 US Food and Drug Administration. Burke, S., Hammond, and T.