Cell Therapies, a leader in the development, manufacturing and distribution of cell-based therapies, has welcomed an agreement with Novartis to produce their CAR-T cell therapy product KYMRIAH (tisagenlecleucel) in Melbourne.
The agreement will enable the first Australian on-shore commercial manufacture and supply of this therapy.
Currently, Australians who receive this immunotherapy have their blood collected and sent overseas to undergo a manufacturing process, before their reprogramed cells are flown back to be reinfused.
“Being able to complete this whole process within Australia is a real game changer for Australian patients,” said Associate Professor Dominic Wall, who is the Executive Director at Peter Mac responsible for cellular immunotherapy.
“On-shore manufacture removes a major bottle-neck of international transport while patients benefit from substantially less time needed from blood collection to reinfusion. CAR T-cell treatments like KYMRIAH can be life-changing for patients who have exhausted all other options and I, along with all of our clinicians at Peter Mac, could not be more delighted by today’s developments.”
In August 2019, CTPL achieved a broad GMP manufacturing licence for T-cell products from the Australian Therapeutic Goods Administration (TGA). The license covers the collection, manufacturing, testing, storage and release for supply of any commercial T-cell product, including all CAR-T cell therapies, as well as any T-cell product for use in clinical trials. CTPL is the first Australian entity to receive such a license.
“Having this license in place significantly de-risks the development process for our clients, as they are assured from the early stages that their product is already manufactured in a way that is compliant with current commercial regulations in Australia,” said Dawn Driscoll, CEO of CTPL.
“The combination of CTPL’s broad TGA license, the national infrastructure provided by the Centre of Excellence in Cellular Immunotherapies housed at Peter Mac, and the agreement with Novartis, means that CTPL’s overall capabilities are at a world-class, pharmaceutical level, and patients will benefit for years to come.”