Melbourne company wins stem cell manufacturing licence

Melbourne biotechnology company Magellan Stem Cells has become one of the first in Australasia to receive a licence to manufacture stem cells by the Therapeutic Good Administration (TGA).

The decision will help reduce Australia’s reliance on overseas manufacturing and encourage the commercialisation of innovative Australian cellular therapeutics, according to Magellan Stem Cells Chief Medical Officer Associate Professor Julien Freitag.

“The licence from the federal regulator places Magellan as one of the few biotechnology companies in Australasia with licensed stem cell manufacturing capability,” he said.

Magellan is the only facility in Australasia currently manufacturing mesenchymal stem cells for pivotal late-stage research in humans. Mesenchymal stem cells are multipotent stem cells that can differentiate into various cell types, including bone, cartilage and muscle. They hold particular promise in the treatment of degenerative and debilitating musculoskeletal disorders.

“Magellan’s development of a TGA-licensed dedicated cell therapy manufacturing facility improves Australia’s capabilities in advanced manufacturing technologies, supports Australia’s medical science industry and reduces our reliance on overseas manufacturing,” Freitag said. “The cell and gene therapy manufacturing market is estimated to be worth more than US$15 billion annually, with an annual growth of 20%. This is despite internationally there being a 500% shortfall in manufacturing capability against demand.”

Magellan’s TGA-licensed cell therapy manufacturing facility has the capacity to leverage international clinical research demand and make an invaluable contribution to Australia’s economy and healthcare system, Freitag added.

In further recognition of Magellan’s research success, the Australian Government’s Medical Research Future Fund last year provided a $7 million grant to Magellan to undertake late-stage stem cell research on Magellan’s proprietary donor stem cell product (MAG200), designed to treat osteoarthritis in people’s joints.

“Magellan is planning further groundbreaking clinical research which promises to have a significant socioeconomic impact in addressing the clinical unmet need of osteoarthritis,” Freitag said.

Image: Supplied.