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Clinical evaluation of messenger RNA involves vaccination of tens of thousands of participants requiring the production of a sufficient quantity of mRNA drug substance. Manufacturing and testing require additional material to account for analytical testing and to account for production loss from the process. Achieving high productivity upstream requires optimization of IVT reaction conditions. All the reagents and components used in the reaction can be subject to optimization aiming at yield and quality increase. This process development step can be accelerated with rapid and accurate analytical methods, ensuring robust and consistent IVT production. Downstream, implementation of efficient and scalable purification methods early in development leads to higher productivity and shorter development timelines.
In this GEN webinar, our expert presenter will detail a versatile analytical HPLC assay aimed at optimization of IVT reaction yields and determination of mRNA capping efficiency. Furthermore, downstream solutions are outlined to improve mRNA stability and achieve production capacities targeting production scales required for clinical testing.”
A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.
Produced with support from:
Product Manager, mRNA
Sartorius
