Draft guideline on the Development and Manufacture of Synthetic Peptides

Recently, the public consultation started of this draft guideline. It addresses specific aspects regarding the manufacturing process (eg solid phase peptide synthesis, fragment condensation), characterization, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances.

Synthetic peptides are at the interface of small molecules and proteins and, from a quality point of view, specific considerations apply to this class of therapeutics. Synthetic peptides are fully or partially (depending on the size) excluded from the scope of ICH guidelines such as Q3A/B, Q6A/B and ICH M7. The purpose of this guideline is to set out the type of information required for the development, manufacture and control of synthetic peptides (existing or new chemical entities) used in a medicinal product.

The guideline also contains requirements and considerations related to conjugation, medicinal product development and clinical trial applications (human products only). Furthermore, it provides guidance when using biological peptides as European reference product as the biosimilar regulatory pathway is not possible for chemically synthesized peptides (which are not considered biological substances).

If you are manufacturing synthetic peptides and need any assistance with building your Drug Substance section, ASMF, CTA or MAA please contact us  for more information.