Point-Of-Care Manufacturing Successfully Treats B-Cell Cancers; How Will FDA Regulate It?

22 Dec 2021

• By Shannon Brown

In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.

Point-of-care manufacturing successfully used to manufacture T-cells for cancer treatment • Source: Alamy

In what the authors call the first study of its kind, a team of researchers at the non-profit Caring Cross have successfully used point-of-care manufacturing technology to create T-cells to treat patients with B-cell malignancies – specifically, children with acute lymphocytic leukemia and adults with non-Hodgkin lymphoma.

The study, published on 10 December in Nature Communications, describes how researchers were able to manufacture CAR19 T-cells in as...