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Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products

Capaldi, Daniel, Akhtar, Nadim, Atherton, Tom, Benstead, David, Charaf, Ayman, De Vijlder, Thomas, Heatherington, Carl, Hoernschemeyer, Joerg, Jiang, Hong, Rieder, Ulrike, Ring, Francis, Peter, Robert, Stolee, Jessica and Wechselberger, Rainer (2020) Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products. Nucleic Acid Therapeutics (00). ISSN 2159-33372159-3345


A risk-based approach for routine identity testing of therapeutic oligonucleotide drug substances and drug products is described. Risk analysis of solid-phase oligonucleotide synthesis indicates that intact mass measurement is a powerful technique for confirming synthesis of the intended oligonucleotide. Further risk assessment suggests that the addition of a second, sequence-sensitive identity test, which relies on a comparison of some property of the sample to a reference standard of proven identity, results in a sufficient test of identity for most oligonucleotide drug substances and products. Alternative strategies for drug product identity testing are presented. The analysis creates a common way to communicate risk and should result in a harmonized approach to identity testing that avoids the unnecessary analytical burden associated with routine de novo
sequencing, without compromising quality or patient safety.

Item Type: Article
Keywords: Oligonucleotides, identification, sequence confirmation, risk assessment, GMP controls, intact mass measurement
Date Deposited: 25 Sep 2020 00:45
Last Modified: 25 Sep 2020 00:45


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