U.S. Pharmacopeia Acknowledges Early Days for mRNA—Seek Comments for mRNA Analytical Procedure/Quality Standards

The rise of mRNA was solidified by the COVID-19 pandemic and unprecedented government funding of mRNA-based vaccines targeting SARS-CoV-2.&nbsp; Thus, mRNA vaccines emerged as the first modality to receive emergency use authorization and then approval for COVID-19 in America. Also promising are future use cases, such as use for addressing future pandemics as well as other infectious diseases, such as rabies, Zika, and&nbsp;cytomegalovirus infection; plus, the fact that there are several mRNA-based products in clinical pipelines from cystic fibrosis to various cancers, suggest the technology is now prime time.&nbsp; Consequently, &nbsp;the United States Pharmacopeia (USP)  has issued a 2nd edition of Draft Guidelines entitled: &ldquo;Analytical Procedures for mRNA Vaccine Quality.&rdquo;
What is United States Pharmacopeia or &ldquo;USP&rdquo;?