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Considerations for a Decentralized Manufacturing Paradigm

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Nature Communications 12, no. 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. New Project: Evolutive Vaccines Facility for Sanofi.” Biotechnology Progress 36, no.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Pharmaceutical Engineering 41, no. Draft Guidance for Industry.

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Regulatory Landscape for Raw Materials: CMC Considerations

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In addition, single-use technologies have been increasingly employed throughout manufacturing because of the advantages they offer, including reductions in cost, manufacturing footprint, contamination risk, and processing times (Figure 1). There is undoubtedly a need for improved supply chain flexibility to address shortages.