Establishment of a guideline on the development and manufacture of synthetic peptides - Scientific guideline

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This concept paper addresses the need to establish a guideline on the development and manufacture of synthetic peptides. The number of clinical trial applications for human products and marketing authorisation applications for synthetic peptides for both human and veterinary products significantly increased over the last few years.

From an analytical and regulatory perspective, peptides are interesting since they present a link between products derived from biotechnology and small molecular chemical compounds.

Furthermore, synthetic peptides are fully or partially excluded from the scope of ICH Q3A/B (VICH GL10/GL11), ICH Q6A/B (VICH GL39/GL40) and ICH M7 21 (EMA/CVMP/SWP/377245/2016). It is therefore proposed to establish a guideline addressing those specific aspects regarding the manufacturing process, characterisation, specifications and analytical  control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) and Chemistry of Active Substances for veterinary medicinal products (EMA/CVMP/QWP/707366/2017).

Keywords: Chemistry, development and manufacture, drug substance, new active substance, synthetic peptides

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