IOPC 2019 Presentation Request

CMC Considerations for mRNA based Therapeutics

Messenger ribonucleic acid (mRNA) has the potential to treat a wide range of human diseases by exploiting natural in vivo protein synthesis machinery. With advancement of mRNA based therapeutics through clinical phases comes the requirement for mRNA characterisation and establishment of GMP validated analytical methods for quality control. Testing can include measuring the size or molecular weight of the mRNA, characterisation of the 5′ cap structure and poly (A) tail, as well as tests for impurities which can be directly linked to translation efficiency and immunogenicity. Analysis of the associated delivery systems, such as lipid nanoparticles, also forms a key part of mRNA drug product testing. This presentation will give an overview of the analytical considerations for mRNA therapeutics.

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