Improving understanding of processes offers dual benefits for oligonucleotide development. Firstly, it establishes a potential platform for creating similar molecules with different sequences, thereby accelerating process development time /efforts. Secondly, it ensures robust processes that yield high-quality APIs. While Quality by Design (QbD) is often equated with Design of Experiments (DoE), it actually encompasses overall process design, with DoE being just one aspect.
While alternative methods are being explored, solid-supported synthesis remains the most established and practical approach for producing oligonucleotides, especially in smaller quantities. Before 2016, the main focus was on introducing oligonucleotides as therapeutics. However, with over 15 approvals in an 8-year period, and considering the potential for a platform approach, developing a strategy for process characterization would greatly benefit the overall oligonucleotide portfolio and streamline the filing process with a deeper understanding. This study emphasizes the importance of the Quality by Design (QbD) concept from development through to product lifecycle.
