QRM Tools for Contract Biomanufacturing

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.