title: Quality specifications for peptide drugs: a regulatory-pharmaceutical approach.
abstract: Peptide drugs, as all types of pharmaceuticals, require adequate specifications (i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug substances (i.e. active pharmaceutical ingredients) and drug products (i.e. finished pharmaceutical dosage forms). Compendial monographs are updated regularly to keep up with the most recent advances in peptide synthesis (e.g. reduced by-products) and analytical technology. Nevertheless, currently applied pharmacopoeial peptide specifications are barely harmonized yet (e.g. large differences between the European Pharmacopoeia and the United States Pharmacopeia), increasing the manufacturers' burden of performing analytical procedures in different ways, using different acceptance criteria. Additionally, the peptide monographs are not always consistent within a single pharmacopoeia. In this review, we highlight the main differences and similarities in compendial peptide specifications (including identification, purity and assay). Based on comparison, and together with additional information from peptide drug substance manufacturers and public evaluation reports on registration files of non-pharmacopoeial peptide drugs, a consistent monograph structure is proposed.
authors.affiliation: Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
authors.forename: Valentijn
authors.initials: V
authors.lastname: Vergote
authors.forename: Christian
authors.initials: C
authors.lastname: Burvenich
authors.forename: Christophe
authors.initials: C
authors.lastname: Van de Wiele
authors.forename: Bart
authors.initials: B
authors.lastname: De Spiegeleer
mesh_terms: D010455:Peptides / Q000627:therapeutic use*; D004364:Pharmaceutical Preparations / Q000592:standards*; D010602:Pharmacopoeias as Topic; D011786:Quality Control
chemical_list: D010455:Peptides; D004364:Pharmaceutical Preparations