Background & Aim A method for the non-viral transposon based manufacture of CAR19.41BBz T-cells for the Phase I CARTELL (UTN: U1111- 1204-6974) and AUTOCAR19 (U1111-1226-8682) clinical trials has previously been described. The original method was non-Good Manufacturing Practice (GMP) standard, and used a traditional opencontainer electroporation system. The method presented here is a modification of the original method to GMP standard to incorporate the fully enclosed Lonza 4-D Nucleofector LV Unit XL cartridge system and eliminate open-container cell handling and processing. For GMP applications, closed electroporation systems are preferable to open-container systems, such as the older 4-D X-unit nucleocuvettes offered by Lonza, as they reduce the risk of product contamination.

Closed-system transposon-mediated manufacture of GMP grade CAR T-cells via the Lonza Nucleofector LV XL - Cytotherapy (isct-cytotherapy.org)