Formulation & Process Development Considerations for Non-Viral Gene Delivery

Comirnaty® and Spikevax® along with siRNA-LNP based Onpattro® have demonstrated the manufacturability and clinical viability of LNP based nanocarriers. In development of LNP based drug product, the choice of each lipid component and the manufacturing technology is one of the key factors for success. The choice of lipid matrix can be modulated to maneuver and change the biodistribution of LNPs depending on the organ of interest and type of nucleic acid. The manufacturing technology can have significant impact on the biophysical properties, structural characteristics, colloidal stability, and efficacy of the LNP. This study describes the key considerations for designing LNP formulations and impact of different manufacturing parameters and the scale up consideration to enable successful LNP drug product manufacturing.

Amey Bandekar, Associate Director - Biologics Drug Product Development & Manufacturing , Sanofi