Melbourne company wins stem cell manufacturing licence in Australian first

A Melbourne biotechnology company has become one of the first in Australasia to receive a licence to manufacture stem cells, potentially reducing Australia’s reliance on overseas bio-tech manufacturers.

The Therapeutic Goods Administration granted Magellan Stem Cells the manufacturing licence for its Braeside facility in Melbourne’s southeast, the company announced this week.

The decision places Magellan among the few biotechnology companies in Australasia with licensed stem-cell manufacturing capability and makes it the only facility currently manufacturing mesenchymal stem cells for late-stage human research.

Chief Medical Officer Associate Professor Julien Freitag said the licence would help reduce Australia’s reliance on overseas manufacturing and encourage commercialisation of innovative Australian cellular therapeutics.

“The TGA licence application process is detailed and rigorous and I am grateful to our staff who worked tirelessly to ensure compliance with the TGA’s world-leading standards,” Freitag said.

Mesenchymal stem cells are multipotent stem cells that can transform into various cell types, including bone, cartilage and muscle, holding particular promise for treating degenerative musculoskeletal disorders.

Magellan is focusing its research on osteoarthritis, a painful condition affecting more than three million Australians and hundreds of millions of people worldwide.

The company has spent 15 years developing expertise in manufacturing mesenchymal stem cells for clinical applications and is planning further clinical research into its proprietary donor stem cell product MAG200, designed to treat joint osteoarthritis.

The TGA licence follows a $7 million Federal Government Medical Research Future Fund grant awarded to Magellan in September last year to undertake late-stage stem-cell research.

Freitag said the cell and gene therapy manufacturing market was worth more than $15 billion annually with 20 per cent annual growth, despite a 500 per cent shortfall in manufacturing capability against demand internationally.

“Magellan’s cell therapy manufacturing capability will give Australian patients access to innovative clinical trials and expedite access to life-changing therapies,” Freitag said.

The licence comes after Magellan published successful results from Phase I/IIa trials for MAG200 in Osteoarthritis and Cartilage Open.

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