Peptide-based therapeutics: quality specifications, regulatory considerations, and prospects

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• Harmonized pharmacopoeial peptide monograph will reduce manufacturer’s burden. • Quality assessment of peptides is crucial to ensure optimal safety to patients. • Purity characterization of peptides is critical for development of peptide therapeutics. • Global peptides therapeutic market is predicted to flourish in near future.

Exquisite selectivity, remarkable efficacy, and minimal toxicity are key attributes inherently assigned to peptides, resulting in increased research interest from the pharmaceutical industry in peptide-based therapeutics (PbTs). Pharmacopoeias develop authoritative standards for PbT by providing standard specifications and test methods. Nevertheless, a lack of harmonization in test procedures adopted for PbT in the latest editions of Pharmacopoeias has been observed. Adoption of a harmonized monograph could increase further the interest of the global pharmaceutical industry in PbTs. Here, we provide an overview of pharmacopoeial methodologies and specifications commonly observed in PbT monographs and highlight the main differences among the pharmacopoeias in terms of the active pharmaceutical ingredients that they focus on. We also address the prospects for PbTs to mature as a new therapeutic niche.

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