An AusBiotech-led consortium is mapping GMP manufacturing capability for regenerative medicine in Australia, a burgeoning sector which attracted $25.7 billion in financing globally in 2020 alone.
The recent news of Cell Therapies’ Good Manufacturing Practice (GMP) license from the TGA for T-Cell products highlighted the importance of the mapping exercise, said AusBiotech.
AusBiotech, Medicines Australia, Cell Therapies, Novartis Pharmaceuticals Australia, Biointelect, Research Strategies Australia, and MTPConnect are carrying out a 12-month study of the sector, with funding assistance from MTPConnect (the Growth Centre for medical technologies.)
Outcomes of the RM Catalyst Project, announced in November, will include:
- Establishing annual data points and information resources to: map/benchmark GMP manufacturing capability and capacity; establish a model for an annual clinical trial database; and capture investments in Australian RM;
- A researched, strategic roadmap for the RM sector’s development in Australia, including sub-reports on skill and talent specific to the sector; determining a plan to attract patient venture capital investment and the role of Australian biotech companies partnering with global companies; and case studies;
- Determining a sustainable funding and model structure for an RM sector ‘catalyst’ collaboration body;
- A regulatory white paper;
- Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
- Mapping the global pipeline of gene and cell therapy products on the horizon.
Regenerative medicine sector holds great potential, according to AusBiotech, with over 1,200 clinical trials in progress, 152 trials of them at phase 3 now, and the attraction of $25.7 billion (US$19.9 billion) in financing during 2020 alone.
Last week Cell Therapies, a contract manufacturer located at the Peter MacCallum Cancer Centre in Melbourne, received TGA approval to make Novartis’s chimeric antigen receptor T-cell (CAR-T) therapy.
This made it “the first and only approved commercial manufacturing site for CAR-T in Australia for both clinical trial and non-clinical trial patients,” CT said.
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