Proprietary Ionizable Lipids

With independent intellectual property rights, Ionizable Lipid 007 and Ionizable Lipid 009 are ideal for use in prophylactic and cancer vaccines. These two lipids have undergone comprehensive validation processes, including:

• CMC (Chemistry, Manufacturing, and Controls) process validation
• Stability assessments
• Efficacy and safety evaluations

The results demonstrate that these ionizable lipids offer superior transfection efficiency compared to benchmark lipids across various tested applications, including gene therapy and vaccine development.

To assess the stability of ionizable lipids in LNP formulations, we evaluated the size, polydispersity index (PDI), mRNA encapsulation efficiency, and integrity of Ionizable Lipid 007 and Ionizable Lipid 009. The results indicate that both Ionizable Lipid 007 and Ionizable Lipid 009 demonstrate excellent colloidal and RNA stability profiles when stored at 2-8°C.

To further assess the effectiveness of Ionizable Lipids in LNP formulations, we developed LNP formulations using Ionizable Lipid 007 and Ionizable Lipid 009 and evaluated their efficacy in the RSV mRNA vaccine. The results showed that Ionizable Lipid 007 in the LNP elicited a 4-fold increase in RSV neutralizing antibody potency compared to a commercially available LNP positive control. Additionally, both Ionizable Lipid 007 and Ionizable Lipid 009 demonstrated comparable levels of anti-PreF fusion protein antibodies to those of the commercially available LNP positive control.

To see more data and cases, please download the data flyer >>