The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. On September 15th 2022, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.
- Concept paper on the establishment of a guideline on the development and manufacture of synthetic peptides (EMA/CHMP/QWP/735422/2022)
- Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides (EMA/CHMP/QWP/735422/2022)
According to EMA, the proposed guidelines would address aspects of peptide and oligonucleotide manufacturing, characterisation, specification, and analytical control “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).”
In addition to the current lack of specific guidelines, EMA cited increased industry interest in the development of peptide and oligonucleotide-based medicines as a motivation for development of the proposed guidelines. Agency also referenced the EDQM’s Technical Guide for the Elaboration of Monographs on Synthetic Peptides and Recombinant DNA Proteins, which covers the elaboration of monographs for synthetic peptides and products of recombinant DNA (rDNA) technology, as a foundation.