Cell Therapies (CTPL), a manufacturer and distributor of cell-based therapies, has been granted a product class (T-cells) GMP manufacturing licence by the TGA for commercial supply of these cells.
This new license allows for the collection, manufacturing, testing, storage and release for the supply of any commercial T-Cell product, including CAR-T cell therapy.
“This license affords everyone involved a huge benefit, it’s also an acknowledgement of confidence in us from the TGA,” said Associate Professor Dominic Wall, CSO of Cell Therapies.
“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. 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.”
According to Gerry McKiernan, the quality manager of CTPL, “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.”
With this new manufacturing license, CTPL is becoming the Australian ‘local manufacturing hub’ for commercially approved products.