ISPE

SEPTEMBER 11, 2023

2 October 2019. Manufacturing Biological Medicines on Demand: Safety and Efficacy of Granulocyte Colony-Stimulating Factor in a Mouse Model of Total Body Irradiation.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” New Project: Evolutive Vaccines Facility for Sanofi.” 11 September 2019.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

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. Published November 2019. Published November 2019.

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Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

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. Published November 2019. 9 Lo Surdo, J. Cauchon, C.

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Documentation FDA Packaging Communication 52