Anita Y. Szajek, PhD, is a senior scientist at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8325.
Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations
USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
USP evaluates raw materials used in the chemical synthesis of peptides.