We are NOT Doctors but, we read this very important briefing document from the FDA because our evo Cold Chain 2.0 system will be part of the manufacturing process for Car-T cells. Very interesting that the FDA highlighted the challenges in manufacturing this new therapy. Specifically, they mentioned the challenge of controlling process variability: "It is also critical to understand and address sources of variability seen in the individual products. This can be a challenging issue given the complex and labor-intensive manufacturing processes involved with making a CAR T cell product"
Control of process variability is one of the most important outcomes of adopting the evo Cold Chain 2.0 system. The superior thermal performance and data reporting of our 2-8C evo's (designed specifically for the inbound leg), and our new DV -196C cryo shippers dramatically reduces process variability.
4.1.1 Control of tisagenlecleucel quality through manufacturing process controls
A major consideration for manufacturing tisagenlecleucel is the establishment of a well- controlled manufacturing process that can consistently produce high-quality CAR T cells that are safe, pure, and potent. Consistency in product quality is necessary to provide reasonable confidence that each lot (batch) of tisagenlecleucel will perform as expected at a given dose in patients.
In order to control the manufacturing process for consistency, it is necessary to thoroughly understand the manufacturing process and critical product quality attributes unique to the autologous CAR T cell products. It is also critical to understand and address sources of variability seen in the individual products. This can be a challenging issue given the complex and labor-intensive manufacturing processes involved with making a CAR T cell product (Figure 1). These challenges can include variability in the starting materials (e.g., patient’s own leukapheresis cells) and human or animal derived reagents (e.g., serum, antibodies); and control of critical components that may be manufactured under contract (e.g., transfer vectors that encode CAR, final container).
Novartis Briefing Document: Click Here
FDA Briefing Document: Click Here