Analytical Solutions for mRNA Vaccines and Therapeutics Critical quality attributes of mRNA therapeutics mRNA * Identify (sequence confirmation)* * Purity (truncated forms, dsRNA, uncapped)* * 5' capping efficiency* * 3' poly(A) tail length* * Process-related post translation modifications* Schematic representation of in vitro transcribed (IVT) mRNA Schematic representation of in vitro transcribed (IVT) mRNA 5' cap structure m7GpppN 5' UTR 5' UTR with Challenges: * Release specifications have not been standardized * Robust sequencing methods need to be developed Kozak translation initiation sequence LNP * Lipid purity* * Lipid composition* * Stability * Size, polydispersity index (PDI), zeta potential * Encapsulation * Ionizable lipid pharmacokinetics and metabolism* * LC, MS solutions are required or available Modified or unmodified nucleosides ORF - gene of interest 3' UTR 3' Poly(A) tail AAAAAAN 3' UTR with globin sequence 28 | GENengnews.comhttps://www.genengnews.com https://www.genengnews.com