Lipid nanoparticles (LNPs) are pivotal in nucleic acid delivery technologies, advancing therapeutic applications. However, challenges in manufacturing and characterization must be addressed, including ensuring drug product integrity, achieving sufficient recovery during purification while maintaining functionality, and producing a well-purified product. To achieve precise separation and a uniform, functional product, purification using CIM monolithic columns have been developed.
Purification and characterization become increasingly critical as product complexity grows, such as encapsulating multiple payloads or adding targeting moieties to the surface.Monolithic columns can be used for efficient purification of LNPs, as an alternative to standard processes (TFF and dialysis). Mobile phases for purification are optimized for high recovery, stability, and functionality. Compared to standard processes, the novel chromatographic method using CIM monoliths demonstrates superior activity and uniformity due to reduced size distribution and enhanced activity. Integrating monolithic technology ensures consistent product quality and process efficiency, supporting safe and effective LNP-based therapies.
Learning Objectives:
Upon completion, participants will learn of novel methods for LNP downstream, that go beyond filtration and buffer exchange.
Upon completion, participants will be able recall past issues of LNP manufacturing and develop a differnet process.
Upon completion, participant will be able to apply chromatographic purification for LNPs using monolithic columns.
Upon completion, participants will be able to better manufacture tLNP formulations.
Upon completions, participants will be able to learn about intact LNP separation techniques.
