Local biotech earns green light to manufacture next-gen cell therapies

A Melbourne-based biotech company has secured a stem cell manufacturing licence from the Therapeutic Goods Administration (TGA), a move that strengthens Australia’s push to commercialise cutting-edge cell therapies and reduce dependence on overseas manufacturing.

“The licence from the federal regulator places Magellan as one of the few biotechnology companies in Australasia with licenced stem-cell manufacturing capability,” said Associate Professor Julien Freitag, Chief Medical Officer at Magellan Stem Cells.

The company is currently the only facility in Australasia producing mesenchymal stem cells for late-stage human research, particularly targeting degenerative and debilitating musculoskeletal disorders, such as osteoarthritis.

The timing is significant, with the global cell and gene therapy manufacturing market valued at over $US15 billion and expanding at an annual rate of 20%. Yet, demand is vastly outstripping supply.

“Internationally there is a 500% shortfall in manufacturing capability against demand,” Associate Professor Freitag explained.

The regulatory milestone follows the announcement of a $7 million Medical Research Future Fund (MRFF) grant awarded to Magellan last year.

“The TGA licence is crucial for Magellan’s plans to continue our pivotal research into stem cells and their use for the treatment of osteoarthritis and other debilitating musculoskeletal conditions,” said Associate Professor Freitag.

Osteoarthritis affects over three million Australians and hundreds of millions globally, making it a significant clinical and socioeconomic burden.

“Magellan has pursued a structured research and development pathway over the past 15 years and established expertise in the manufacturing of mesenchymal stem cells for clinical applications including osteoarthritis,” Associate Professor Freitag stated. “Magellan’s cell therapy manufacturing capability will give Australian patients access to innovative clinical trials and expedite access to life-changing therapies.”

The MRFF grant will support Magellan’s late-stage research on MAG200, a proprietary donor-derived stem cell product developed for osteoarthritis. This follows the successful results of the company’s Phase I/IIa trials released last year, with more clinical research in the pipeline.

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