Capabilities

The Centre’s Translation Laboratory has extensive expertise in the performing in vitro and in vivo testing of CAR-T and other immunotherapy products to generate safety and efficacy data for regulatory packages to the TGA and HREC committees.

The Translation Laboratory team can also develop the product method of GMP manufacturing. This expedites the technology transfer process via co-located manufacturing partners, Cell Therapies Pty Ltd., minimising timelines to GMP production.

In addition, the Translation Laboratory team can assist in the following:

• CAR (Chimeric Antigen Receptor) design
• CAR-T cell generation for preclinical research
• Human and murine in vitro assays to assess CAR-T cell functionality
• Murine in vivo models to assess CAR-T cell efficacy and safety
• Translational and correlative work to support clinical trial readouts

The Development Program package includes procurement of GMP and GMP-like reagents suitable for a TGA regulated Phase I, first-in-human clinical trial and all associated quality controls.

The Centre is physically co-located with the program’s manufacturing partners, Cell Therapies Pty. Ltd. We work collaboratively to establish efficient, robust GMP manufacturing processes for CAR-T and other cellular therapy products.

Through regular interaction and engagement, processes developed in the Translation Laboratory can be seamlessly transferred to Cell Therapies cleanrooms for tech transfer and process qualification runs.

All clinical trials run through the Development Program are Peter MacCallum Cancer Centre sponsored studies. A member of the Peter Mac cellular immunotherapy clinical service will be appointed as the study Principal Investigator (PI), deploying their expertise in running clinical trials centred on cell-based technologies.

The Centre maintains robust collaborative partnerships within the Peter Mac clinical trial ecosystem that are instrumental in facilitating the seamless establishment and operation of our clinical trials. This includes close engagement with Peter Mac sponsorship via the Clinical Research Development and Operations (CRDO), the Centre for Biostatistics and Clinical Trials (BaCT), and the Parkville Cancer Clinical Trials Unit (PCCTU) teams. These core partnerships underpin the efficiency and efficacy of the development program’s endeavours.