The clinical success of CAR-T therapy has make it as a major high potential cancer therapy approach. With the increase of more industry companies and clinical trials, it’s quite urgent to require a more standard GMP manufacturing process. It include several different parts for CAR-T therapy process as show below. Each step requires a very stringent GMP-level manufacturing and controls.
The purity of collected samples can affect the final CAR-T efficiency. The contaminators like monocytes and granulocyes can be removed by size by centrifuge. All target cells like CD4/CD8 positive T cell can be sorted by Miltenyi ciliniMACs that’s comparable with GMP clinical grade. All the antibody has to be also produced under GMP facilities, same as the activation parts.
Following gene modification, T cells carried by CAR have to be expanded in vitro before injection into patient. The G-Rex from Wilson is a scalable and clinical-level machine that could meet the needs for both functionality and clinical grade. It’s a closed system and collects the final target sample for downstream application.
Although the whole process is monitored under GMP condition, the final products have to be also verified by key factors including viability, identity, purity, potency, stability and microbial testing.
This review give a quite detail introduction and explanation to tell us the importance and key factors that’s involved in CAR-T GMP manufacturing process. It give us a lot of hints during CAR-T clinical development stage.
