Accelerated development of mRNA-based vaccine has necessitated the transformation of standard, research grade in vitro transcription reagents into raw material specifically designed and manufactured under advanced quality standards. The TheraPure grade reagents for mRNA-based vaccine represents Thermo Fisher Scientific’s highest level of purity for mRNA synthesis reagents, with products manufactured using high-definition analytics and tightly controlled purity standards. The TheraPure grade portfolio offers a unique integrated solution for mRNA synthesis, including animal origin-free and ampicillin-free enzymes.

Here, we will discuss the quality requirements for critical raw material for commercial mRNA production and ongoing projects to optimize the entire mRNA portfolio to meet fit-for-purpose standards.