TGA approves Cell Therapies Pty Ltd as the first Australian commercial CAR-T manufacturing site

  • Cell Therapies Pty Ltd, a contract manufacturing organisation located within the Peter MacCallum Cancer Centre, Melbourne, has become the first approved local CAR-T commercial manufacturing site for Kymriah®
  • Kymriah® (tisagenlecleucel), a chimeric antigen receptor T-cell (CAR-T) one-time treatment developed by Novartis, will be the first commercially approved CAR-T therapy to be manufactured in Australia
  • Cell Therapies Pty Ltd will be one of six commercial approved manufacturing sites worldwide as part of the extensive Novartis’ CAR-T Kymriah® manufacturing network

 

Cell Therapies Pty Ltd, a leading provider of cGMP contract manufacturing and deployment services for cell and gene therapy products in the Asia Pacific region, is proud to announce it has received TGA approval to manufacture Novartis’ CAR-T therapy, Kymriah® (tisagenlecleucel) right here in Melbourne, Australia. This will bring faster access to treatment for eligible Australians with life-threatening blood cancers.

 

The Therapeutic Goods Administration (TGA) has granted approval for Cell Therapies Pty Ltd to commence commercial manufacturing of Kymriah®, a chimeric antigen receptor T-cell (CAR-T) one-time treatment, in its manufacturing facility, which is located within the Peter MacCallum Cancer Centre in Melbourne, Australia.

The approval makes Cell Therapies the first and only approved commercial manufacturing site for CAR-T in Australia for both clinical trial and non-clinical trial patients. Cell Therapies has been engaged in CAR-T development and clinical trial manufacturing for clinical investigators and other clients for over 10 years.

The Kymriah® manufacturing process is highly complex and requires a number of carefully performed steps. The patient’s cells are first extracted then reprogrammed in the manufacturing facility and returned as a personalised, one-time treatment for infusion back into the patient.

Until now this advanced manufacturing process was conducted either in the Novartis Morris Plains facility in New Jersey, USA, or another approved overseas facility.

Today’s TGA approval is the culmination of Cell Therapies’ experience and dedication to providing these cutting-edge treatments to the Australian healthcare system.

Interim Chief Executive Officer of Cell Therapies, Associate Professor Dominic Wall said: “This important milestone is good news for patients, the clinical community and the economy. We anticipate this announcement will provide a significant economic boost through the creation of new highly-skilled jobs, now and into the future.”

“It requires an extraordinary amount of cross-functional coordination to manufacture Kymriah® and prepare for the reinfusion. Cells are reprogrammed, grown and stringently tested in compliance with the Good Manufacturing Practice (GMP) standards,” said Dr Wendy Fleming, Director of Production at Cell Therapies. “I am proud to say that the team at Cell Therapies are ready to deliver this therapy to Australian patients.”

 

About Cell Therapies Pty Ltd

Cell Therapies Pty Ltd is one of the most experienced cGMP-compliant manufacturers for cell therapies, gene therapies, cellular immunotherapies and regenerative medicine products globally. Since 2003, Cell Therapies has provided the essential infrastructure for delivery of cell-based therapeutics into clinical trials and commercial markets around the world. The company has successfully helped develop products and processes that are compliant with global regulatory and cGMP requirements and have successfully integrated with global manufacturing networks. Cell Therapies’ expertise is “needle-to-needle”, ensuring complete product control from collection management (especially apheresis) to cell processing to distribution for clinical or commercial supply.

Cell Therapies has a 10-cleanroom facility at the Peter MacCallum Cancer Centre in Melbourne, Australia, where these facilities are available on a fee-for-service basis to the world’s leading cell therapy companies.  This facility is licensed by the Australian TGA for cGMP manufacturing of T-cell products for commercial supply, ensuring all products meet local and global regulatory standards. An expansion to the manufacturing facility, with larger, commercial-scale cleanrooms, is currently in progress and will be fully commissioned in the first half of 2022, providing increased capacity to support future products.

Contact information:

Cell Therapies Pty Ltd

Level 9, 305 Grattan Street

Melbourne VIC 3000

Australia

Phone: +61 3 8559 7310

Email: [email protected]

 

References

[1] Kymriah® approved product information: https://www.novartis.com.au/products/healthcare-professionals