European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Yet in 2021, 100 nanomedicines had been marketed.

Process Improvement 74

Process Improvement Packaging Vaccines FDA 74

ISPE

SEPTEMBER 11, 2023

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.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

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. Pharmaceutical Engineering 41, no. Draft Guidance for Industry.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

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.

Documentation 52

Documentation FDA Packaging Communication 52