AZ cites FasTCAR to drive speedier cell therapy production

AstraZeneca substantially raised its stake in the cell therapy space in 2023, culminating in the acquisition of Chinese biopharmaceutical company Gracell Biotechnologies for $1.2 billion.

The deal added Gracell’s FasTCAR manufacturing technology, which claims to significantly shorten manufacturing time for chimeric antigen receptor (CAR) T-cell therapies. The firm spoke about the acquisition and the technology on its Q4 financial call last week:

“The FasTCAR platform has several key benefits,” Susan Galbraith, EVP of Oncology R&D, told stakeholder. “First, it significantly reduces the manufacturing time from between one and three weeks to 22 to 36 hours, with the opportunity to improve medium turnaround time and also enable increased manufacturing capacity as well as predictability of CAR-T delivery.

“Second, a lower dose of cells needs to be manufactured for each patient, which reduces the risk of cytokine release syndrome, and that can improve the safety profile. And third, the shorter manufacturing time delivers fitter T-cells, and this potentially improves the efficacy of this CAR-T.”

Shorter timelines and smaller doses equate to greater scalability, Galbraith added. “The amount of time that you need to process each individual patient's batch is also shorter within the manufacturing facility. So what that means is that you do get increased capacity for a given of the manufacturing building that you've created.”

She continued: “But also it means that you can be more predictable about the delivery. And because you are actually generating a smaller total number of the cells that have to be delivered to the patient, the likelihood of success of each of those is higher. So all of these things, I think, contribute to the overall benefit that we see from the FasTCAR process.”

Gracell’s presentation of Phase I data for multiple myeloma candidate GC012F at the American Society of Hematology (ASH) meeting in December demonstrated the promise of such therapies in an earlier line setting. “We believe that GC012F has potential applications across hematologic malignancies, including multiple myeloma, and will further bolster our hematology pipeline,” Galbraith added.

The comments came days after AstraZeneca revealed plans to build an 84,000 square-foot facility in Rockville, Maryland to support T-cell production. The $300 million investment forms part of the firm’s “whole cell therapy ambition,” said CFO Aradhana Sarin on the call.

Other recent expansions in the CGT space include the acquisition of Neogene, the addition of preclinical gene therapies from Pfizer, and a $245 million in allogeneic CAR-T firm Cellectis.