At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of mRNA vaccines and their components, namely:
- mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, i.e. mRNA-LNP medicinal products;
- mRNA substances for the production of mRNA vaccines for human use (5.39), covering mRNA active substances used in the manufacture of mRNA vaccines;
- DNA templates for the preparation of mRNA substances (5.40), covering the linear DNA template used as starting material for the preparation of mRNA substances.
This new series of European Pharmacopoeia (Ph. Eur.) texts on mRNA vaccines is the result of the collaborative work and active engagement of the Ph. Eur.’s mRNAVAC Working Party – a large and dynamic group comprising specialists representing industry, academia, licensing authorities and national control laboratories from around the world…
