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

Abstract

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
URI:	https://oak.novartis.com/id/eprint/42527