Revolutionizing mRNA Production: the paradigm-breaking Ntensify™ continuous-batch RNA system

Patrick C Thiaville, Jose Castillo, Emilie Gateau


    The field of RNA manufacturing has witnessed significant progress in recent years, fueled by advancements in synthetic biology, enzymology, and process engineering. Our thorough technology and process development led to the deployment of the first available high-performance continuous-batch RNA manufacturing system. Our predefined and standardized process does not require scale-up or process development and combined with our robotic equipment produces high quality RNA drug-substance (DS) compatible with therapeutics and vaccines. We performed > 250 IVT reactions using more than 45 different DNA constructs varying in length from 900 bases to > 4kb. The data demonstrates the process efficiency scales going from single milligram to multi-gram batches of mRNA. The process produced mRNA with > 85% integrity, > 90% capping efficiency, > 90% poly-A tail length. Also, the process produces very low impurities with < 130 ng/mg of dsRNA and < 1.2 ng/mg residual DNA while maintaining > 80 % product recovery. 

    Viral Vectored Gene therapies approved worldwide