In this free webinar, learn about scalable mRNA production, including the mRNA workflow scales from micrograms to multi-grams, supported by rapid high-pressure liquid chromatography (HPLC) monitoring. Attendees will learn how the in vitro transcription (IVT) reaction is optimized using a design-of-experiment approach, improving yield and minimizing double-stranded RNA (dsRNA) formation. The featured speaker will discuss high-throughput chromatography tools for microgram-scale purification to effectively remove IVT components and dsRNA. The speaker will also share why reducing the innate immune response is critical for the clinical efficacy of mRNA therapies.
TORONTO, Sept. 10, 2024 /PRNewswire-PRWeb/ -- The COVID-19 pandemic triggered an unprecedented surge in the development of messenger ribonucleic acid (mRNA)-based vaccines and other therapeutics such as protein replacement therapies.
mRNAs are produced by a cell-free process based on the in vitro transcription (IVT) reaction, a RNA-polymerase-catalyzed polycondensation of nucleoside triphosphates (NTPs) into a nascent mRNA chain guided by the deoxyribonucleic acid (DNA) template. The mRNA production workflow is adaptable to production from milligram to multigram scale, supported by the high-pressure liquid chromatography (HPLC) monitoring of the consumption of NTPs with the concomitant production of mRNA. It also integrates quality by design (QbD) principles to ensure robustness and scalability.
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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