Development and manufacture of synthetic peptides - Scientific guideline
HumanScientific guidelines
This guideline addresses 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) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to medicinal product development, to synthetic peptide development using biological peptides as European reference medicinal product, and to clinical trial applications (human products only).
Keywords: Guideline, synthetic peptide, solid phase synthesis, liquid phase synthesis, fragment condensation, comparability, amino acids, solid support resinlinker, conjugation, deprotection, coupling, capping, cleavage, pooling strategy, stereoisomers, deletion sequence, truncated sequence, insertion sequence, immunogenicity, sterilisation, generics