Platform Strategies for Synthetic Oligonucleotides

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

Galileo Galilei (1564-1642) Acknowledgements

Die Neugier steht immer an erster Stelle eines Problems, das gelöst werden will