Course Description:
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.
Who should participate:
- Regulatory scientists
- Analytical scientists
- Quality assurance analysts
- R&D scientists and managers
- Quality control analysts
- Contract research organizations
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 and features a presentation by Katharine Duncan.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.