Cartherics taps Catalent iPSC platform for CAR-NK manufacturing

Cartherics, an Australia-based developer of immune cell therapies, and global contract development and manufacturing organization Catalent announced an expanded commercial license agreement to support manufacturing and commercialization of chimeric antigen receptor natural killer (CAR-NK) cell therapies.

Under the agreement, Cartherics will use a Catalent cGMP-compliant induced pluripotent stem cell (iPSC) line to manufacture iPSC-derived CAR-NK therapies, including its lead candidate CTH-401. The companies said the licensed iPSC line is part of a portfolio of clinical-grade, donor-consented cell lines supported by validated workflows for reprogramming, expansion, gene editing, differentiation, and quality control.

According to the announcement, Cartherics has received clearance from the U.S. Food and Drug Administration to use the iPSC line as the starting material for CTH-401, and the companies have demonstrated compatibility between the therapy and Catalent’s iPSC-NK manufacturing platform.

The agreement is intended to support late-stage clinical and commercial manufacturing, while allowing Cartherics to retain the ability to produce clinical trial material and participate in downstream manufacturing as programs advance. The companies said the collaboration is designed to enable scalable, cost-effective production of off-the-shelf cell therapies.

The expansion builds on Catalent’s broader work in iPSC-based manufacturing. Last month, the company announced a partnership with GelMEDIX to support process development, analytical services, scale-up, and GMP manufacturing of iPSC-derived therapies for ocular and retinal diseases.