A complete LNP formulation requires four lipid components, each fulfilling a distinct structural or functional role. Three of these — structural phospholipids, cholesterol, and PEG-lipids — are commercially available from multiple suppliers at research grade, making them straightforward to source at reasonable cost. The ionizable lipid, however, is the technologically decisive component: it governs RNA encapsulation efficiency, endosomal escape, in vivo organ targeting, and cellular toxicity. It is also historically the most difficult component to obtain, as leading ionizable lipids such as ALC-0315 (used in the Pfizer/BioNTech COVID-19 vaccine) and SM-102 (used in the Moderna vaccine) are subject to patent protection, command significant material costs, and are available from only a limited number of suppliers at higher quantities.
We have developed a portfolio of proprietary ionizable lipids (EUFECT®) that are available in milligram to gram quantities for research collaborations and formulation projects. These lipids were designed to improve upon the limitations of the first-generation benchmark compounds ALC-0315 and SM-102 — specifically with respect to the balance between transfection efficiency and cytotoxicity, which has remained a challenge particularly in sensitive primary cell types.
Steinbeis-Innovationszentrum