Since synthetic peptides are specifically excluded from many regulatory guidance documents – in particular, those relating to specifications for drug substances and drug products – the development of appropriate specifications for regulatory filings can present significant challenges during peptide drug development. Because of this, the United States Pharmacopeia (USP) has recently proposed a new monograph – <1503> Quality Attributes of Synthetic Peptide Drug Substances – which discusses potential quality attributes and associated test methods to be considered for inclusion in specifications for peptide drug substances. The presentation will review the recommendations provided in the new monograph in the context of existing regulatory guidance, with particular focus on peptide-related impurities, their identification and the development of methods for their quantification.

Dr. Verlander is currently acting as an independent consultant supporting the pharmaceutical industry in the areas of product development and quality and regulatory compliance; he also serves as a member of USP’s Biologics Monographs-1 Peptides and Oligonucleotides Expert Committee, as well as their Glatiramer Acetate Expert Panel. Prior to this, he gained extensive experience in the areas of quality assurance and regulatory affairs in contract manufacturing organizations specializing in peptide APIs, including: the PolyPeptide Group [as President of PolyPeptide Laboratories San Diego (2009-2013), Global Director of Quality Assurance and Regulatory Affairs (2003-2009), and Executive Vice President, Quality Assurance and Regulatory Affairs and Co-founder, PolyPeptide Laboratories, Inc. (1996-2009)]; and Bachem California [as Vice President, Technical and Regulatory Affairs (1986-1996)]. He has also worked in the area of peptide research and development [as Director of Peptide Research and Peptide Production, Immunetech Pharmaceuticals (1985-1986); Research Director, BioResearch, Inc. (1978-1985); and as a member of the research faculty at the University of California, San Diego, Department of Chemistry (1972-1978)].