How CAR-T Automation is Primed to Change the Industry
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.”​
Business strategy​
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,”​