Discover an informative webinar that focuses on the transformative development of mRNA-based vaccines and therapeutics and explores the production and purification processes of mRNA, from the in vitro transcription (IVT) reaction to advanced chromatographic techniques.
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.
Speaker
Rok Sekirnik, Head Process Development for mRNA and pDNA, Sartorius BIA Separations
Rok Sekirnik graduated with a degree in Chemistry from the University of Oxford, where he also completed his PhD. He has worked in the areas of mAb, vaccine and gene therapy vector development in scientific and management roles.
His team at Sartorius BIA Separations is focused on developing high-yielding, cost-effective purification approaches for pDNA and mRNA production.
Message PresenterWho Should Attend?
This webinar will appeal to Scientists/Managers in the following fields or those working in pharma, biopharma, biotech, CDMO companies or academia:
- Purification
- Downstream processing
- Scientist/Manager in PD
- mRNA purification
- Manager MSAT
- Director of Scientific Innovation
What You Will Learn
Attendees will learn about:
- Scalable mRNA Production: The mRNA workflow scales from micrograms to multi-grams, supported by rapid HPLC monitoring
- Optimization via Design-of-Experiment: The IVT reaction is optimized using a design-of-experiment approach, improving yield and minimizing dsRNA formation
- Efficient Purification: High-throughput chromatography tools for microgram-scale purification effectively remove IVT components and dsRNA
- Clinical Impact: Reducing innate immune response is critical for the clinical efficacy of mRNA therapies
Xtalks Partner
Sartorius
Sartorius BIA Separations develops and manufactures market-leading CIM® monolithic chromatographic columns for the purification and analysis of large biomolecules, such as viruses, plasmids, and mRNA, which are applied in cell and gene therapies. The company’s Cornerstone® Biomanufacturing Development Services are the result of more than 25 years of hands-on experience with the most challenging biopharmaceutical products and offer a comprehensive approach of integrated process development solutions and novel technology designed to improve the robustness and yield of large biomolecules production while improving the safety of therapeutic products. Sartorius BIA’s technology for manufacturing-scale purification is already used in the production of the first commercialized advanced therapeutics; the company also has a keen presence with novel drug candidates in the clinical pipeline.
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