Development of a Strategic Quality Control Program for mRNA Vaccines

Figure 1: Structural elements of messenger RNA

Messenger RNA (mRNA) therapeutics have the potential to revolutionize several areas of medicine, including the prophylaxis of infectious disease. That potential is driven not only by therapeutic advantages of this modality, but also the relative ease in which a product can be produced and scaled — thus reducing cost and importantly, time to market. mRNA therapeutics have an enhanced safety profile driven in part from their mode of action not requiring integration into the host-cell genome.

mRNA vaccines are a relatively new concept, and little regulatory guidance is available on product characterization or quality control. To support mRNA vaccines through development and to market — ensuring safe and efficacious vaccines — thus requires a strategic science-led program to be implemented that identifies critical attributes and enables their evaluation and, ultimately, their control.

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