Biomedical manufacturer Cell Therapies has announced the opening of new cell and gene therapy GMP (good manufacturing practice) manufacturing facilities to meet future patient demand at Victoria’s Peter MacCallum Cancer Centre.
The facility is Australia’s only biomedical manufacturing facility where CAR T-cells and other ‘living’ cancer therapies can be made at a commercial scale.
In CAR T-cell therapy a patient’s immune cell or T cells are modifieded in the laboratory so they will bind to cancer cells and kill them.
According to the company, the expansion increases capacity to support high throughput manufacture of commercial cell and gene therapy products.
Acting Chief Executive of Cell Therapies Associate Professor Dominic Wall said: “The facilities in Melbourne, Australia, are now on par with only a handful of sites globally and combined with a highly specialised workforce, mean we have the ability to make more of these innovative treatments to support the growing demand in Asia Pacific.”
The facility expansion includes three large-scale high-throughput good manufacturing practice (GMP) manufacturing suites suitable for supply of late-phase clinical trial and commercial products with a production capacity of up to 2,000 patient doses per year.
The new capacity builds on Cell Therapies’ existing 10 GMP cleanrooms, quality system, and support infrastructure for early to mid-phase clinical trial supply.
The expansion solidifies the contract development and manufacturing organisation’s (CDMO) capabilities across the whole product development pipeline, from translation to commercial supply.
Professor Wall said: “As the most experienced contract manufacturer in the Asia Pacific region, our facilities and quality systems have met many international regulatory agency requirements, including those of the Australian TGA, the US FDA, Japan’s PMDA, and Europe’s EMA.”
With expanded short-term storage, and in-house analytical testing, Cell Therapies offers what it calla a ‘needle-to-needle’ service for clients.
Picture: Cell Therapies