The Platform Technology Approach to mRNA Product Development and Regulation
John H. Skerritt,
Carolyn Tucek-Szabo,
Brett Sutton
et al.
Abstract:mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially unchanged manufacturing and analytical methods often utilised for different products. It is critical not to lose the momentum built using the platform approach during the development, regulatory approval and rollout of vaccines for SARS-CoV-2 and its variants. This … Show more
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