For the first time in Australia, Cell Therapies Pty Ltd (CTPL), a recognised leader in the manufacturing and distribution of cell-based therapies, has been granted a product class (T-cells) GMP manufacturing licence by the Therapeutic Goods Administration (TGA) for commercial supply of these cells. This new license, specifically for CTPL and its clients, allows for the collection, manufacturing, testing, storage and release for supply of any commercial T-Cell product (including the exciting and revolutionary cancer treatment, CAR-T cell therapy). This represents a significant milestone (and advantage) for Australia, CTPL, its clients and most importantly, patients in need.
“This license 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. “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”.
Gerry McKiernan the Quality Manager of CTPL said: “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. With a regulator pre-approved Technical Transfer process, CTPL is able to significantly de-risk their client’s product registration with a clear path to rapid local manufacturing approval. 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.
Teamed with a favourable Australian clinical trial landscape for cell and gene therapy, and its establishment within the heart of the prestigious Parkville Biomedical Precinct, CTPL has taken another stride towards its mission of being the manufacturing and distribution centre of excellence for the cellular therapies globally. CTPL helps with the development and supply of new therapies that provide new and promising treatment for severe and unmet clinical needs, such as patients suffering rare and aggressive cancers. With the announcement of this new award, CTPL looks forward to continuing its mission more effectively and successfully than ever.
About Cell Therapies Pty Ltd (CTPL)
CTPL is a leading provider of cGMP contract manufacturing and deployment services for cell and gene therapy products in the Asia Pacific. CTPL is dedicated to enabling patient access to, and furthering the development of, these ground-breaking therapies on behalf of clients from around the world. Building on more than 15 years’ experience and strategic partnerships with our owner, Peter MacCallum Cancer Centre in Melbourne Australia, we provide a complete process development and GMP product supply service from translational studies through to commercial supply and can serve as a single access point for regional deployment of cellular therapies for our clients. We have TGA licences that allow us to safely manufacture and supply these CAR-T therapies to patients in Australia.
Cell Therapies Pty Ltd
Level 9, 305 Grattan Street
Melbourne VIC 3000
Phone: +61 3 8559 7310
Email: [email protected]