Connecting the World of Oligonucleotide R&D With Early Clinical Scale Manufacturing

Moving an oligonucleotide therapeutic from R&D into early clinical development introduces new expectations for synthesis, purification, analytics and quality control. Decisions made during candidate screening, including sequence design, chemical modifications and material quality, can have consequences as a program scales.

This webinar examines the differences between small-scale and pilot-scale oligonucleotide manufacturing and explains why impurity profiles can influence biological results and candidate selection. Learn how synthesis efficiency, solid-phase support, DMT-ON versus DMT-OFF purification, ion-exchange chromatography and analytical methods affect product quality. The speakers also explore when developers should begin considering endotoxins, residual solvents, bioburden, sequence confirmation and other quality attributes.

The session offers practical guidance for determining when to transition to larger-scale production and how to avoid overcomplicating oligonucleotide design or setting unnecessarily stringent acceptance criteria too early. Watch the webinar to learn how thoughtful planning can help bridge the gap between oligonucleotide discovery and early clinical manufacturing.