ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Viral antigen vaccines. For example: Live vaccine manufacturing. Complete Data Gathering.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MARCH 8, 2023

5 , 8 Compounding pharmacies were commonly mentioned as sources of microbial cross-contamination, especially in the US. 9 , 15 This has led to compounding pharmacies completing high-volume activities such as mass repackaging, thereby increasing the risk of cross-contamination. million vials, 26 had to be recalled and destroyed.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

Pharmaceutical Technology

JULY 23, 2008

The world’s biggest pharmaceutical company Pfizer announced in June 2008 that it would be putting its “full scope and scale” behind a push into the cancer market. “And there’s a tremendous opportunity to meet their needs.” So what’s driving the growth?

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Chemotherapy 40

Pharmaceutical Technology

MARCH 22, 2023

During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry. While production volumes have now fallen, future vaccine demand is hard to predict, as booster shots could be needed at any point to control emerging variants.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Published 2008. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. Published May 2012.

Documentation 52

Documentation FDA Packaging Communication 52