Biomanufacturers Demand Higher Quality Standards in 2016

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

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

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.

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

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.