During past years, mRNA products have come into focus as a potential new drug class to deliver genetic information. To date, many mRNA-based therapeutics, such as cancer vaccine development and gene therapy therapeutics, have been developed for multiple applications. However, all genetic sequences are susceptible to random mutation. According to the regulatory requirements of the FDA, strict quality control should be conducted in the preclinical phase to assure product safety, identity, quality, purity, and strength (including potency). Moreover, orthogonal analytical techniques should be applied to assess the quality of all components including all materials and components used for the manufacture of a gene therapy product such as vectors, reagents, and excipients.
","author_name":"Jerry Carter"}