Analysis of Lipid Nanoparticles

Over the last several years, our definition of biotherapeutics has evolved from solely protein-based therapeutics, such as monoclonal antibodies (mAbs), to include such product classes as cell and gene therapies. Cell and gene therapies are unique products that require innovative and new approaches to formulation, specifically related to drug delivery. One such delivery modality that has gained significant traction is lipid nanoparticles (LNPs), which, as their name suggests, are nanoparticles comprised of lipids. The first LNP product approved by the United States Food and Drug Administration, was the liposome-encapsulated Doxil, whereas, in 2018, the United States Food and Drug Administration approved the small interfering RNA (siRNA) product Onpattro, using lipid nanoparticles as part of its formulation. Since then, LNPs have gained more international attention in their role in drug delivery because of the mRNA-based COVID-19 vaccines. LNPs in the biopharmaceutical space are still in their infancy related to our understanding of them and how to characterize them, presenting both challenges and opportunities. In this column, we discuss some of those challenges and opportunities and look at the current and future landscape of the most common analytical tools used to analyze and characterize LNP
As our understanding of biotherapeutics expands to include new products such as cell and gene therapies, we are presented with new challenges and opportunities in the characterization of these products. [...]