In August, Novartis made history when its product Kymriah (tisagenlecleucel) became the first chimeric antigen receptor (CAR) T-cell therapy to win US approval.
The product is made by collecting a patient’s cells through apheresis at a specialised clinic before shipping them to a manufacturing site where they are modified, expanded and tested. These are then shipped back to the clinic and infused into the patient as a one-off treatment.
The process is expensive, and while Novartis faced criticism from payers and patient groups for its $475,000 (€400,000) price-tag, it is considerably less than the $600-750,000 expected for this sort of personalised medicine.
But ThermoGenesis Corp, a subsidiary of Cesca Therapeutics, is looking to radically reduce the cost of CAR-T therapies through its CAR-TXpress platform, and according to chief technical officer Philip Coelho: “From what we understand about the current Kymriah manufacturing process, we believe the costs could drop by a factor of five.”
CAR-TXpress cartridge platform
ThermoGenesis’ platform is based on a family of sterile, functionally closed and disposable cartridges that automate the previously manual cell-washing, cell isolation and cell selection steps of CAR-T cell manufacturing.
These address the many inefficiencies involved in CAR-T processing, Coelho told us. In the cell isolation stage, for example, “X-LAB cartridges automate the isolation of MNCs from blood or leukapheresis products in a functionally closed system retaining nearly 100% of the CD3+ cells in the isolated MNC fraction without the use of any additives.”
And he added the platform has greater efficiency in the cell selection process due to the use of microscopic antibody-coated bubbles (microbubbles) which attach to and gently float the target CD3 cells to the top of CAR-TXpress’ X-BACS cartridge.
Due to the automated nature of the platform, Coelho said “construction and maintenance of CAR-T manufacturing facilities are simplified,” by eliminating the usual requirement for laminar flow hoods and high-end cleanrooms, while minimizing labour costs.
Furthermore, product consistency is improved as “the CAR-TXpress System’s automated cartridges eliminate the inter-operator and intra-operator variability that are inevitable in manual processing steps, and which too often result in final cell yields failing to achieve the required cell dose.”
The firm acquired the cell processing technology from privately-held Californian firm SynGen Inc in July, and according to Coelho is now looking to offer the platform as a third-party service.
“We are in preliminary discussion with a number of institutions whose names I cannot disclose at this time,” he told Biopharma-Reporter.
“Currently we are only manufacturing in our own facility but expect the process to be validated at a major academic institution before the end of 2017,”