Throughput-scalable manufacturing of SARS-CoV-2 mRNA lipid nanoparticle vaccines.

ABSTRACT: Lipid nanoparticles (LNPs) are a potent delivery technology that have made it possible for the recent clinical breakthroughs in mRNA therapeutics and vaccines. A key challenge to the broader implementation of mRNA therapeutics and vaccines is the development of technology to produce precisely defined LNP formulations, with throughput that can scale from discovery to commercial manufacturing and meet the stringent manufacturing standards of the pharmaceutical industry. To address these challenges, we have developed a microfluidic chip that incorporates 1×, 10×, or 256× LNP-generating units that achieve scalable production rates of up to 17 L/h of precisely defined LNPs. Using these chips, we demonstrate that LNP physical properties and potency in vivo are unchanged as throughput is scaled.

SUBMITTER: Shepherd SJ 

PROVIDER: S-EPMC10438381 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature