Enhancing mRNA Capture with Resolute BioSMB and CIMmultus Oligo dT

This technical report presents a proof-of-concept study demonstrating the application of the Resolute® BioSMB system for continuous mRNA capture chromatography using CIMmultus® Oligo dT monolith devices. The study outlines the significant transformation in bioprocessing towards efficient continuous manufacturing, particularly in the context of mRNA production. The report details breakthrough curve experiments that determined optimal conditions for continuous bind-and-elute processing, achieving high yields of approximately 97%. It further explains the methodologies of multi-column chromatography (MCC), including batch multi-column chromatography (B-MCC) and sequential multi-column chromatography (S-MCC), emphasizing their roles in enhancing productivity and reducing media costs. The Resolute® BioSMB platform is described as scalable from process development to commercial manufacturing, facilitating the transition from traditional batch processes to intensified multi-column processes. The findings indicate that continuous loading with monolith devices can significantly increase productivity while maintaining product quality, addressing the critical need for effective drug substance supply post-COVID-19 pandemic.