Abstract
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, characterization 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. This article presents a method for the simultaneous characterization of both attributes in a single sample preparation workflow. The method involves lipid extraction, various RNAse enzymes, purification steps and LC–MS to analyze the capping and poly(A) tailing.
Publisher
Multimedia Pharma Sciences, LLC