title: Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides.
abstract: Peptides are a fast growing segment in the pharmaceutical industry. Consequently, the industry and regulatory agencies are increasing their focus on the regulatory path and quality considerations for peptide development and manufacturing. Although most peptides are synthetic, manufactured by solid phase synthesis, nevertheless they are complex molecules with challenging quality and regulatory aspects. This paper provides a structured overview of relevant quality issues for chemically synthesized peptides used as active pharmaceutical ingredients (API) in drug products. It addresses the unique characteristics of peptides pertaining to structural and physicochemical characterization, manufacturing and in process controls, impurities and aggregates arising from manufacturing and storage, along with their potential impact on safety (including immunogenicity) and efficacy of the peptide drug products.
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America. Electronic address: Larisa.Wu@fda.hhs.gov.
authors.forename: Larisa C
authors.initials: LC
authors.lastname: Wu
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America.
authors.forename: Fu
authors.initials: F
authors.lastname: Chen
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America.
authors.forename: Sau L
authors.initials: SL
authors.lastname: Lee
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America.
authors.forename: Andre
authors.initials: A
authors.lastname: Raw
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America.
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
mesh_terms: D016568:Drugs, Generic; D007880:Legislation, Drug; D010455:Peptides; D011786:Quality Control
chemical_list: D016568:Drugs, Generic; D010455:Peptides
keywords: Peptide; Peptide structure; Quality control; Regulatory; Risk assessment; Solid phase peptide synthesis