Free Webinar: This expert presentation addresses key manufacturing challenges in therapeutic oligonucleotide production as programs scale toward clinical and commercial supply. Topics include guide RNA synthesis, cleavage and deprotection scale-up, stereoisomer control in HPLC purification, and API concentration strategies for lyophilized and solution-based manufacturing.
As oligonucleotide programs advance toward clinical and commercial supply, manufacturing processes must address increasing complexity across molecule types, modifications, and batch sizes. This expert presentation explores practical approaches to key manufacturing challenges in therapeutic oligonucleotide production, including guide RNA synthesis, cleavage and deprotection scale-up, stereoisomer control during HPLC purification, and API concentration before lyophilization or solution API manufacturing.
In this TIDES USA spotlight presentation, Sven Warhaut, Ph.D., shares BioSpring’s perspective on how targeted process development and manufacturing improvements can help support demanding oligonucleotide programs from early development through commercial supply. The presentation highlights selected case studies, including scalable guide RNA manufacturing, representative scale-down models for process development, analytical strategies for purification control, and osmolyte-assisted UF/DF for high-concentration API manufacturing.
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