Multi-attribute monitoring of therapeutic mRNA by LC-MS
Therapeutic mRNA is receiving growing interest in various therapeutic applications such as genome editing, cancer immunotherapy and prophylactic vaccines. As with other drugs, it is essential to guarantee product quality. Among the critical quality attributes of therapeutic mRNA, characterisation of the capping and poly(A) tail are of the greatest importance because of their involvement in mRNA stability and in the efficiency of protein synthesis.
We present a novel method for the simultaneous characterisation of both attributes in a single sample preparation workflow as well as an extraction step to enable the analysis of lipid formulation. This innovative approach aims to minimise the amount of sample required and reduce the time needed to conduct experiments. Our method involves combining various RNase enzymes, purification steps and LC/MS to analyse the capping and poly(A) tailing.
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