Manufacturing and Process Scale-Up
Ian Oesterle, PhD
Scientist
EPFL, Switzerland
Microfluidic mixing is widely used for lab-scale lipid nanoparticle (LNP) production [1], but integration of formulation, solvent removal, and ligand conjugation into a single controllable workflow has never been addressed. Hence, we developed a modular multi-step microfluidic platform that combines LNP formation with on-line solvent removal and conjugation to enable screening-oriented generation of effective ligand-coated LNP. With this platform, anti-CD5 LNP with mRNA of anti-GD2 and anti-PTPRZ1 CAR constructs were produced and CAR T generation validated ex vivo in Jurkat cells, human and murine primary T cells, and in vivo in C57BL/6 mice.