The Therapeutic Good Administration has granted Magellan Stem Cells a stem-cell manufacturing licence.
The decision will help reduce Australia's reliance on overseas manufacturing and encourage the commercialisation of innovative Australian cellular therapeutics, Magellan Stem Cells Chief Medical Officer, Associate Professor Julien Freitag said.
"The licence from the federal regulator places Magellan as one of the few biotechnology companies in Australasia with licenced stem-cell manufacturing capability."
Melbourne-based Magellan is the only facility in the Australasia currently manufacturing mesenchymal stem cells for pivotal late-stage research in humans, Associate Professor Freitag said.
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-licenced 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, Associate Professor Freitag said.
"The cell and gene therapy manufacturing market is estimated to be worth more than $US15 billion annually, with an annual growth of 20 per cent. This is despite internationally there being a 500 per cent shortfall in manufacturing capability against demand," he said.
Magellan's TGA licenced 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, Associate Professor Freitag said.
The TGA licence follows the announcement of a $7 million Federal Government Medical Research Future Fund grant to Magellan.
Welcoming the TGA licence decision, Magellan Stem Cells Chief Medical Officer, Associate Professor Julien Freitag said: "Magellan Stem Cells is delighted that the TGA has issued a licence to manufacture stem cells at our new plant at Braeside in Melbourne's southeast.
"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.
"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.
Associate Professor Freitag said osteoarthritis is a painful and debilitating condition that affects more than three million Australians and hundreds of millions of people across the world.
"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 said.
"Magellan's cell therapy manufacturing capability with give Australian patients access to innovative clinical trials and expedite access to life-changing therapies."
In further recognition of Magellan's research success, the Federal Government Medical Research Future Fund, in September of 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.
MAG200 is designed to treat osteoarthritis in people's joints.
The $7 million grant announcement followed the publication of the results of Magellan's successful Phase I/IIa trials for MAG200 in Osteoarthritis and Cartilage Open.
Magellan is planning further groundbreaking clinical research which promises to have a significant socioeconomic impact in addressing the clinical unmet need of osteoarthritis, Associate Professor Freitag said.
Key Facts:
Australian regulator grants Magellan Stem Cells a licence for the manufacture of stem cells
Decision helps reduce Australia's reliance on overseas manufacturing and encourages the commercialisation of innovative Australian cellular therapeutics
Melbourne-based Magellan is one of the few biotechnology companies in Australasia with licenced cell manufacturing capability
Global cell and gene therapy manufacturing market is estimated to be worth more than $US15 billion annually, with surging demand massively outstripping manufacturing capacity
Move follows $7 million federal grant to help Magellan conduct further human trials of stem cell technology for the treatment of osteoarthrirtis
