Development and manufacture of oligonucleotides - Scientific guideline

This guideline addresses 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) or Chemistry of Active  Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to active substance in solution, to medicinal product development, to oligonucleotide generics development, to oligonucleotide personalised medicine approaches and to clinical trial applications (human products only).

Keywords: Guideline, oligonucleotides, solid phase synthesis, comparability, phosphoramidites, solid support resin, linker, conjugation, deprotection, coupling, capping, cleavage, pooling strategy, stereoisomers, deletion sequence, truncated sequence, insertion sequence, immunogenicity, sterilisation, generics, prior knowledge, active substance in solution, personalised medicines

Current version

Draft guideline on the development and manufacture of oligonucleotides

Consultation dates: 22/07/2024 to 31/01/2025Draft: consultation openReference Number: EMA/CHMP/CVMP/QWP/262313/202424Summary:

This guideline addresses 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) or Chemistry of Active  Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to active substance in solution, to medicinal60
product development, to oligonucleotide generics development, to oligonucleotide personalised medicine approaches and to clinical trial applications (human products only).

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Document history

Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides

Consultation dates: 20/09/2022 to 20/12/2022Draft: consultation closedReference Number: EMA/CHMP/QWP/735423/2022