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

OCTOBER 26, 2022

In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging. Most Board members were able to attend in person, and we had very productive Board and Executive Committee sessions.

Packaging 52

Packaging Compounding Communication Vaccines 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Documentation 52

Documentation FDA Packaging Communication 52