Optimizing mRNA production: achieving 25 g/L mRNA yield with low dsRNA by integrating PAT

Join us for an in-depth exploration of mRNA manufacturing workflow, designed to enhance efficiency and scalability.

mRNA production requires DNA template as a critical raw material. In the webinar, discover an efficient purification process comprising scalable continuous in-line lysis, anion exchange chromatography (AEX) capture, and selective hydrophobic interaction chromatography (SHIC) for polishing supercoiled (sc)DNA. At-line monitoring of scDNA linearization ensures complete conversion in minimal time, optimizing reagent consumption.

DNA template is used in IVT production, which can be scaled from micrograms to multi-grams with rapid at-line PATfix monitoring of nucleoside triphosphate (NTP) consumption and mRNA production. A data-driven model of process yield can be derived to optimize reaction cost drivers, and minimize dsRNA formation - a critical quality attribute in mRNA products.

Our speaker will demonstrate how to achieve IVT yields of 25 g/L in batch mode and how to design an efficient fed-batch IVT reaction. He will also show how to optimize purification at µg-scale using multiparallel (96 well) and spin-based devices in Oligo dT and SDVB chemistries, and scale these methods to multi-mg levels for clinical manufacturing.

Watch the webinar to learn how to:

• Achieve scalable preparation of high-quality DNA template
• Understand the use of at-line analytics to monitor the IVT reaction
• Couple PAT with DOE to increase yield of IVT to 25 g/L
• Use affinity chromatography for isolation of mRNA
• Remove dsRNA, residual DNA template and RNA fragments in scalable fashion

Rok Sekirnik

Head Process Development for mRNA and pDNA at

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 various roles, including Principal Scientist at Novartis and Project Manager at Batavia Biosciences. His team at BIA Separations is focused on developing high-yielding, cost-effective purification approaches for pDNA and mRNA production.

Watch now

SPEAKERS

Rok Sekirnik

Head Process Development for mRNA and pDNA at

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