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

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This concept paper addresses the need to establish a Guideline on the Development and Manufacture of Synthetic Oligonucleotides. The number of clinical trial applications for human products and marketing authorisation applications for synthetic oligonucleotides for both human and veterinary products has significantly increased over the last few years.

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

Furthermore, synthetic oligonucleotides are fully or partially excluded from the scope of ICH Q3A/B (VICH GL10/GL11), ICH Q6A/B (VICH 23 GL39/GL40) and ICH M7 (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 oligonucleotides 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 oligonucleotides

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