A data-driven model of process yield (in g/L), including the impact of NTP concentration and Mg:NTP ratio on the reaction yield can be derived to optimize the reaction cost drivers (e.g. RNA polymerase and DNA template) while minimizing the dsRNA formation, a critical quality attribute in mRNA products.
mRNA purification can be achieved with affinity chromatography selective for polyadenylated mRNA (Oligo dT) coupled with reverse-phase chromatography, which is used to remove IVT components (NTPs, DNA and T7) and IVT by-products. The elimination of dsRNA improves translation and minimizes the activation of innate immune response. For the development of personalized, mRNA-based therapies, such as neoantigen mRNA vaccines, the minimization of the innate immune response may be critical to the clinical success of mRNA therapeutics.
Register for this webinar today to gain insights into the technological advancements and operational considerations for ensuring the quality by design approach in developing mRNA-based vaccines and therapeutics.
Join Rok Sekirnik, Head Process Development for mRNA and pDNA, Sartorius BIA Separations, for the live webinar on Thursday, September 26, 2024, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Quality by Design in mRNA Manufacturing.
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