title: New and Evolving Techniques for the Characterization of Peptide Therapeutics.
abstract: Advances in technologies related to the design and manufacture of therapeutic peptides have enabled researchers to overcome the biological and technological challenges that have limited their application in the past. As a result, peptides of increasing complexity have become progressively important against a variety of disease targets. Developing peptide drug products brings with it unique scientific challenges consistent with the unique physicochemical properties of peptide molecules. The identification of the proper characterization tools is required in order to develop peptide formulations with the appropriate stability, manufacturability, and bioperformance characteristics. This knowledge supports the build of critical quality attributes and, ultimately, regulatory specifications. The purpose of this review article is to provide an overview of the techniques that are employed for analytical characterization of peptide drug products. The techniques covered are highlighted in the context of peptide drug product understanding and include chemical and biophysical approaches. Emphasis is placed on summarizing the recent literature experience in the field. Finally, the authors provide regulatory perspective on these characterization approaches and discuss some potential areas for further research in the field.
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033. Electronic address: suzanne.daddio2@merck.com.
authors: Suzanne M
authors: SM
authors: D'Addio
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065.
authors: Jameson R
authors: JR
authors: Bothe
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065.
authors: Claudia
authors: C
authors: Neri
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065.
authors: Paul L
authors: PL
authors: Walsh
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania 19486.
authors: Jingtao
authors: J
authors: Zhang
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065.
authors: Elizabeth
authors: E
authors: Pierson
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065.
authors: Yun
authors: Y
authors: Mao
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania 19486.
authors: Marian
authors: M
authors: Gindy
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania 19486.
authors: Anthony
authors: A
authors: Leone
authors: Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033.
authors: Allen C
authors: AC
authors: Templeton
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000639:trends*; D002849:Chromatography, Gas / Q000379:methods / Q000639:trends; D002853:Chromatography, Liquid / Q000379:methods / Q000639:trends; D016503:Drug Delivery Systems / Q000379:methods / Q000639:trends*; D004355:Drug Stability; D006801:Humans; D010455:Peptides / Q000032:analysis* / Q000737:chemistry / Q000627:therapeutic use*; D053719:Tandem Mass Spectrometry / Q000379:methods / Q000639:trends
chemical_list: D010455:Peptides
keywords: analytical chemistry; chemical stability; chromatography; formulation; liquid chromatography; peptides; physical characterization; physicochemical properties; stability