Peptide conjugates are a promising and growing class of peptide therapeutics. They require a specific set of analytical test methods to fully characterize the manufacturing process, its intermediates and the final drug substance. Typically, the physical and chemical properties of the peptide are substantially influenced or dominated by the properties of the conjugated moiety. When a protein is conjugated to a peptide, biochemical methods are best suited as analytical test methods, while PEGylated peptides require analytical test methods that adequately characterize the polymeric moiety. In addition, the determination of the degree of conjugation and the identification and structural elucidation of peptide related impurities in the drug substance is important. An overview on challenges during development of assay and purity methods using different chromatographic and MS techniques will be presented.
This on-demand recording is from USP Biologics’ Annual Peptides & Oligonucleotides Workshop, held November 4-5, 2019 and features a presentation by Thomas Wucherpfennig and Tanja Huth.
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations