Double-Stranded mRNA Testing By ELISA

As mRNA therapeutics continue to transform modern medicine, controlling impurities in the manufacturing process is critical to ensuring both safety and efficacy. One of the most important—and potentially harmful—impurities is double-stranded RNA (dsRNA), an unintended byproduct of in vitro transcription (IVT). Even trace amounts of dsRNA can activate innate immune pathways via receptors like RIG-I, MDA5, and TLR3, triggering inflammation and toxicity. That’s why quantifying dsRNA content is essential before mRNA drug products are released for clinical use.

Pace Life Sciences offers specialized expertise in dsRNA impurity analysis, supported by industry-recognized monoclonal antibodies, such as J2, J5, K1, and K2. Key considerations, such as antibody selection, method linearity, and dsRNA standards—including Poly I: C and chemically defined 142 bp dsRNA—are crucial for optimizing assay sensitivity and accuracy. With experience supporting mRNA programs since 2016, Pace provides customized, high-quality testing services tailored to your specific therapeutic platform. Learn how to mitigate dsRNA risk and accelerate your mRNA therapeutic development.