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Manufacturing and Process Scale-Up

(256) Monoliths for a novel selective and high recovering purification process of RNA-LNP pharmaceuticals

Introduction: Lipid nanoparticles (LNPs) provide the most advanced platform for in vivo drug delivery of nucleic acids. [1] However, they have not been yet developed into a well-characterized biopharmaceutical. Manufacturing challenges include proper formation of drug product, maintaining the integrity of the drug product, achieving sufficient recovery and obtaining a well separated and characterized product. The focus of characterization should be on determining drug substance purity, excipient purity and the entire drug product purity.

Learning Objectives:

  • Upon completion, participant will be able to apply chromatographic purification for LNPs.
  • Upon completion, participant will be able to demonstrate understanding of LNP manufacturing.
  • Upon completion, participant will be able to use chromatography for RNA-LNP characterization.