The diversity and complexity of peptide therapeutics pose challenges for the characterization and impurity control of such medicines. This presentation will offer a review of CMC regulatory experiences and expectations for therapeutic peptides. It will highlight the importance of this therapeutic class, and the caution required for peptide characterization and impurity analysis. The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024.

Subject area:
Biologics

Objectives (If applicable):
na

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations