TGA approves Novartis CAR-T cell manufacturing

The Cell Therapies facility at the Peter McCallum Centre in Melbourne has become the first approved CAR-T commercial manufacturing site in Australia.

The centre aims to provide faster access to CAR-T therapies to eligible patients in the region with life-threatening blood cancers.

Swiss pharmaceutical company Novartis has secured approval from the Therapeutic Good Administration (TGA) to manufacture and supply CAR-T cells commercially in Australia.

Global head of Novartis technical operations Steffen Lang said the company was proud to have the largets CAR-T manufacturing network in the world, which makes therapies accessible to healthcare professionals and patients around the world.

“Cell Therapies, a world-leading manufacturing facility, adds their experience to our leadership in pioneering research, development and supply of cell and gene therapies,” he said. “International collaborations such as these are critical in accelerating advancements in areas of great medical need.”

The CAR-T manufacturing network of Novartis comprises of seven facilities across four continents.

More than 100 patients in Australia have been treated with Novartis CAR-T treatment across clinical trials and commercially available therapy. Local manufacturing means patients’ cells can stay in Australia without the need to ship them overseas.