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Regulatory Issues for Peptide Drugs

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Peptide Therapeutics

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 47))

Abstract

Peptides have characteristics of both proteins and small molecules, making them specific to bind to a target, similar to endogenous molecules. Peptide drugs fall in between small molecules and protein/antibody drugs. There is guidance developed for small molecules and proteins by regulatory agencies. However, for peptide drugs, guidance is limited, and FDA provides the guidelines for submission of data for chemistry and manufacturing of synthetic peptides. According to the FDA guidelines, “Peptide is a polymer composed of 40 or fewer amino acids.” In 2013, the US pharmacopeia convention (USP) formed a therapeutic peptide expert panel, and the panel recommended some guidelines for the quality of peptide synthesis and for considering peptides as an active pharmaceutical ingredient. With the anticipated demand for peptide therapeutics in metabolic diseases, autoimmune diseases, and cancer, there is an expanding market for peptide therapeutics in the next 10 years. Hence, a clear-cut regulatory requirement is essential for this class of therapeutics. This chapter covers some of the developments in the regulatory requirements for peptide-based therapeutics.

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Acknowledgments

This work was supported by funding from the National Cancer Institute of the National Institutes of Health grant 1RO1CA255176 to SJ.

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  1. School of Basic Pharmaceutical and Toxicological Sciences, College of Pharmacy, University of Louisiana at Monroe, Monroe, LA, USA

    Seetharama D. Jois

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Correspondence to Seetharama D. Jois .

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    Seetharama D. Jois

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Jois, S.D. (2022). Regulatory Issues for Peptide Drugs. In: Jois, S.D. (eds) Peptide Therapeutics. AAPS Advances in the Pharmaceutical Sciences Series, vol 47. Springer, Cham. https://doi.org/10.1007/978-3-031-04544-8_9

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