Month: July 2017

The manufacturing process for CAR-T cells is similar, even though the design and structure of the tumor specific scFv (single chain fragment variable) may be proprietary. The methods used to …

CAR T-Cell Therapy HCP Guide – Quality and Education: Necessary Steps Read More

In the manufacturing facility the CAR structure is synthesized using the patient’s own T-cells. The CAR is a fusion protein that contains 3 distinct functional domains. For example, with axicabtagene …

CAR T-Cell Therapy HCP Guide – CAR Structure Read More

Before the bioengineered T-cells are reinfused, the patient undergoes a conditioning chemotherapy regimen to reduced the competing T-cell population (lymphodepletion), lower the tumor burden and help reduce serious complications such …

CAR T-Cell Therapy HCP Guide – Patient Delivery: The Preinfusion Conditioning Regime Read More

CAR T-cell therapy is not yet approved by the FDA and is considered investigational; a patient must enter a clinical trial to receive it. Here’s the process: Leukapheresis: The patient’s …

CAR T-Cell Therapy HCP Guide – How Are CAR T-Cells Manufactured? Read More

Axicabtagene ciloleucel (KTE-C19) from Kite Pharma was the first CAR T-cell therapy submitted to the FDA for approval in March 2017. For the current submission, axicabtagene ciloleucel has been studied …

CAR T-Cell Therapy HCP Guide – CAR T-Cell Therapy at the FDA Read More