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Case Study: Fast-Track to Phase I: Two siRNA IND CMC Packages Completed in 14 Months

Abstract: A biotech company engaged WuXi TIDES to develop a siRNA-GalNAc drug candidate for cardiovascular disease. The original synthesis process for this 23-mer siRNA resulted in a yield of 13% and a crude purity of 18%. In addition, the GalNAc moiety was not commercially available. Our team’s objective was to accelerate this challenging molecule to IND filing as fast as possible. Utilizing innovative conjugation chemistry and tailored analytical studies, we significantly improved the crude purity and yield to 75% and 62%, respectively, delivering on this project in a timely and efficient manner.

siRNA casestudy Case Study: Fast-Track to Phase I: Two siRNA IND CMC Packages Completed in 14 Months

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