From autologous to universal: Efficiency strategies to accelerate next-generation immune cell therapy (CAR-NK/iPSC) R&D

Autologous CAR-T therapies have demonstrated remarkable clinical success; however, operational friction can arise due to vein-to-vein logistics, manufacturing variability, and complex supply chains. This creates bottlenecks, limiting scalability and commercial viability. Therefore, now more than ever, operational efficiency is becoming just as critical as innovation in the field of cell therapy.

In this white paper, Creative Biolabs explores the shift from patient-specific cell therapies toward scalable, universal immune cell platforms. Universal strategies, particularly those utilizing CAR-NK and iPSC-derived immune cells, offer advantages such as improved safety profiles, manufacturing scalability and engineering potential. Creative Biolabs outlines a framework to accelerate CAR-NK/iPSC development while minimizing downstream rework, emphasizing early CMC integration, high-efficiency gene delivery and expansion, streamlined vendor workflows and pre-validated component strategy. These strategies demonstrate how cell therapy can be transformed into a repeatable product paradigm built on standardized inputs, controlled variation, and predictable outputs.