Best Practices for Quality Control and Implementation of Single-Use Systems By Jerold Martin

The manufacturing agreement is expected to run through December 2030, subject to change, with production to take place at Samsung Biologics’ Songdo, South Korea, site.

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

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

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

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.