mRNA vaccines and therapeutics are expanding rapidly, in part fueled by the success of COVID-19 vaccines.
Manufacturing mRNA requires significant expertise, equipment, and experience. An essential part of any mRNA compound is the 5’ cap structure. The 5’ cap is critical to the stability, expression, and immunogenicity of an mRNA. In-vitro transcribed mRNA is not capped by default, so capping must be built into the manufacturing process. Currently, there are three major options for capping mRNAs in vitro: Enzymatic capping, ARCA (Anti-Reverse Cap Analog) and CleanCap® capping technology. To assess the complete cost of manufacturing an mRNA therapeutic, it is important to consider the difference in price, time, complexity, and availability for each of these methods. To better understand the complete manufacturing costs, customer experiences, and customer needs with regards to mRNA capping manufacturing, TriLink BioTechnologies commissioned a third-party study. This study, conducted by a third party consulting firm, analyzed the manufacturing costs of the three methods of mRNA capping. The analysis included conversations with 30 subject matter experts, outside of TriLink, who are developing mRNA therapeutics from many different companies across the US and the EU. In this technical note, we present the qualitative findings of this analysis and qualitative quotations from customer experiences to estimate the relative cost of each of these capping methods
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