Cell Therapies

We are a member of the Melbourne Biomedical Precinct and are supported by Therapeutic Innovation Australia, an NCRIS network member.

Our facility is located at the heart of the Melbourne Biomedical Precinct. We have access to hospitals, research institutes, and universities to support product development, translation to the clinic, and patient access. Working closely with our clinical and research collaborators at the Peter MacCallum Cancer Centre, we provide clients with needle-to-needle control with clinical integration for cell and gene therapies.

Needle-to-needle solutions for cell and gene therapies

Our facility holds both commercial supply and clinical trial manufacturing licenses from the Australian Therapeutic Goods Administration (TGA), ensuring the products from our facility meet global regulatory standards such as for U.S. (FDA), Europe (EMA), Japan and other jurisdictions.

We have a 10-cleanroom GMP facility that meets global regulatory and international organisation for standardisation (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S). Our services cover the complete manufacturing process from development to deployment, providing needle-to-needle control with clinical integration.

GMP manufacturing to meet global regulatory standards

Our services cover the complete manufacturing process from program development, clinical trial design and deployment, to commercial supply.