Chemistry, manufacturing and controls strategies for using novel excipients in lipid nanoparticles

• Published in: Nature nanotechnology Vol. 20; no. 3; pp. 331 - 344
• Main Authors: O’Brien Laramy, Matthew, Foley, David A., Pak, Roger H., Lewis, Jacob A., McKinney, Eric, Egan, Patricia M., Yerabolu, Ravikiran, Dane, Eric, Dirat, Olivier, Saunders Gorka, Lindsey, Martinelli, Joseph R., Moussa, Ehab M., Barthuet, Julie
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.03.2025; Nature Publishing Group
• Subjects: 631/61/350/354; 631/61/54/152; 639/638/11; 639/925/352/152; 639/925/357/341; Chemistry and Materials Science; Developmental stages; Drug Industry; Excipients; Excipients - chemistry; Humans; Lipids; Lipids - chemistry; Liposomes; Manufacturing; Materials Science; Nanoparticles; Nanoparticles - chemistry; Nanotechnology; Nanotechnology and Microengineering; Nucleic acids; Perspective; Pharmaceutical industry; Pharmaceuticals; Pharmacodynamics; Pharmacokinetics; Structure-function relationships

Lipid nanoparticles (LNPs) for nucleic acid delivery often use novel lipids as functional excipients to modulate the biodistribution, pharmacokinetics, pharmacodynamics and efficacy of the nucleic acid. Novel excipients used in pharmaceutical products are subject to heightened regulatory scrutiny an...