Impact of ionizable lipid source on quality and stability of siRNA-loaded lipid nanoparticles - PubMed
4 hours ago
- #MC3 purity
- #siRNA-LNP
- #generic drug development
- The study compares how different sources of the ionizable lipid MC3 affect siRNA-loaded lipid nanoparticles (LNPs).
- MC3 purity varied among vendors (86-99%), but LNPs showed similar critical quality attributes (CQAs) like encapsulation efficiency and gene silencing efficacy.
- Despite differences in physicochemical properties (particle size, PDI), in vitro performance (60% TTR knockdown) and biocompatibility remained consistent.
- No significant cytokine induction was observed in human PBMC assays for LNPs made with MC3 from any vendor.
- Stability tests showed changes in particle size and PDI over 70 days at room temperature, but gene silencing efficiency was unaffected.
- Controlling lipid impurities is crucial for ensuring consistent LNP quality, especially for generic drug development.