White papers

Release and characterization of mRNA products

White papers

Analytical confidence from 5' cap to poly-A tail

mRNA quality depends on capping, poly-A tail, integrity and purity, and on clearing process impurities such as dsRNA and template DNA. Whether you work with drug substance or formulated mRNA, we design phase-appropriate analytical strategies that cover identity, purity, stability, potency and safety. Orthogonal methods in one lab, from early development to GMP release.

In this application note we provide an example analytical package for mRNA vaccines, therapeutics and cell and gene therapy programs.