Resources, Guidelines, and Guidance Documents

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.