The Therapeutic Goods Administration (TGA) of Australia has granted Cell Therapies of Melbourne, a product class (T-Cells) GMP manufacturing licence for commercial supply of these cells. The company is the first to gain a licence for this purpose in the country.
This new licence, specifically for Cell Therapies and its clients, allows for the collection, manufacturing, testing, storage and release for the supply of any commercial T-cell product, including the novel cancer treatment, CAR-T cell therapy.
A CDMO, Cell Therapies provides apheresis management, clinical trial support, and consulting and advisory services.
“This licence affords everyone involved a huge benefit, it’s also an acknowledgement of confidence in us from the TGA”, commented A/Prof Dominic Wall, CSO of Cell Therapies.
Australia’s manufacturing hub
With this new manufacturing licence, Cell Therapies is becoming the Australian “local manufacturing hub” for commercially approved products.
“By now being able to provide direct access to the market, we’re able to speed up the production of new and exciting cell therapy treatments,” Wall said. “Our clients can use our services to treat patients faster. It will also help us to accelerate the uptake of new treatments in this new and exciting field of research, and that makes me extremely proud of my team at Cell Therapies”.
Our clients can use our services to treat patients faster. It will also help us to accelerate the uptake of new treatments
With a regulator pre-approved Technical Transfer process, Cell Therapies can significantly de-risk their client’s product registration with a clear path to rapid local manufacturing approval.
Gerry McKiernan, Quality Manager of Cell Therapies, added: “This is the first licence of its type issued in Australia and one of only a few globally. This will greatly assist in bringing these types of therapies to the Australian public. It also demonstrates that we have the requisite systems in place to obtain additional regulatory licences to supply other countries should our clients require this.”
By bringing manufacturing to Australia, Cell Therapies will improve patient care with reduced risk of delays for these cells, which usually require their complex manufacturing to occur in distant sites in Europe or North America.
