Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
Control of impurities for siRNA Therapeutics
This presentation will explain the general approach for control of impurities for siRNA therapeutics.
Control of impurities for Onpattro, the first approved siRNA therapeutic, follows a tiered approach using manufacturing stage appropriate methods designed for individual single strands, siRNA (duplex) drug substance and final (lipid nano particle) drug product. Based on the quality attributes tested, methods are of orthogonal nature and asses impurities both as specified groups as well as individually.