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Our Facility

Industry-leading GMP facility delivering cell and gene therapies from Australia to the world

New commercial-scale manufacturing facility for APAC market supply

Cell Therapies is excited to announce the opening of its new cell and gene therapy GMP manufacturing facilities.

As Australia’s only biomedical manufacturing facility where CAR T-cells and other “living” cancer therapies can be made at a commercial scale, this expansion increases capacity to support high throughput manufacture of clinical trial and commercial cell and gene therapy products for Australian patients and the Asia Pacific market. 

The facility expansion includes three large-scale high-throughput GMP manufacturing suites suitable for supply of late-phase clinical trial and commercial products with a production capacity of up to 2,000 patient doses per year.  

Learn more about our latest expansion:

Explore our new facilities

World-leading GMP manufacturing facility

The facility holds manufacturing licences from Australia’s regulatory agency, the Therapeutic Goods Administration (TGA), for clinical and commercial supply of cell therapies. Our quality and manufacturing standards are compatible with international regulators such as the FDA in the United States of America, EMA in Europe, and MHLW in Japan, and other jurisdictions.

We are located within the Peter MacCallum Cancer Centre which has established itself as the Australian leader in cellular immunotherapy. Our prime location together with our partnerships with hospitals, medical research institutes, and universities, enables us to support the development and translation of cell-based therapies.

Discover the Cell Therapies’ facility

Our facility holds current GMP manufacturing licenses which support supply of cell therapies to multiple PIC/S compliant jurisdictions.

Thirteen clean rooms

Specifically designed for ex vivo cell therapy development and GMP manufacturing, in-house Quality Control laboratory with flow cytometry, BacT/ALERT, qPCR, ELISA and more to meet your clinical and commercial program needs.

TGA Licensed

Our TGA license for T-Cells, including CAR-T products, covers cell collection, processing, storing, release for supply testing, flow cytometry, cell viability and immunobiological testing. This enables us to manufacture Therapeutic Goods for Clinical Trials and Commercial Supply

Robust Quality Systems

We have had over 25 TGA inspections, hold a current GMP manufacturing license, operate quality management systems, and offer GMP-controlled clinical apheresis, cell cryopreservation, and storage capabilities.

Clinically Integrated

We are experienced in the delivery of cell-based products to the clinic and through our partnerships and provide critical infrastructure for the Peter MacCallum Centre of Excellence in Cellular Immunotherapy.

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Explore our services

Cell Therapies has extensive experience in the development and commercialization of cell and gene therapies for the Australian and global markets.

Apheresis Management

We can help you with apheresis collection protocol development, site selection and assessment, network management, cryostorage, and distribution

Contract Manufacturing

We provide rapid technology transfer, process development, manufacturing optimization, clinical trial and commercial product supply to global markets

Clinical Trial Support

We manufacture products for clinical trial, provide process development for programs, manage product storage, and supply logistics and distribution

Consulting and Advisory

Our experts advise on CMC, Australian and international regulatory standards and requirements, and clinical program development