Altevogt, Dominik, Cedillo, Isaiah, Curtis, Corrine, Diorazio, Louis, Faber, Jesse, Jones, Michael, Telford, Alex, Turner, Gillian and Wetter, Christian (2023) Platform Strategies for Synthetic Oligonucleotides. Organic Process Research & Development, 27 (12). pp. 2211-2222. ISSN 1083-61601520-586X

Abstract

Synthetic therapeutic oligonucleotide drug substances are commonly manufactured using the same basic unit operations, i.e., solid phase oligonucleotide synthesis, cleavage and deprotection, purification, and isolation. The platform nature of oligonucleotide drug substance manufacturing provides opportunities to optimize process development, streamline process validation, and expedite regulatory submissions. In this publication, we discuss a modular approach to platform strategies for synthetic oligonucleotide drug substances, the opportunities associated with the application of platform knowledge, and how such information could be presented in regulatory filings.

Item Type:	Article
Keywords:	oligonucleotides, platform data, process validation, manufacturing
Date Deposited:	30 Dec 2023 00:45
Last Modified:	30 Dec 2023 00:45
URI:	https://oak.novartis.com/id/eprint/51050