Developing methods for quantification of dsRNA immunogenic impurities immunogenic impurities

Double-stranded RNA (dsRNA) impurities are a barrier for therapeutic use of mRNAs. DsRNA structures, present in RNA therapeutics, can induce a strong inflammatory response that limits the drug's efficacy, and this is especially true for therapeutics for chronic diseases. There is an increasing interest

from regulatory agencies to demonstrate adequate dsRNA level control and current immunoassays used for dsRNA quantification show limited correlation between dsRNA structure detection and immunogenicity.