Cell Therapies Pty Ltd. is excited to announce the opening of new cell and gene therapy GMP manufacturing facilities to meet future patient demand at the Peter MacCallum Cancer Centre.
As Australia’s only biomedical manufacturing facility where CAR T-cells and other “living” cancer therapies can be made at a commercial scale, this expansion increases capacity to support high throughput manufacture of commercial cell and gene therapy products for Australian patients and the Asia Pacific market.
“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,” said Acting Chief Executive of Cell Therapies Pty Ltd, Associate Professor Dominic Wall.
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. This expansion solidifies the contract development and manufacturing organisation’s (CDMO) capabilities across the whole product development pipeline, from translation to commercial supply.
“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,” confirmed Associate Professor Dominic Wall.
With expanded short-term storage, and in-house analytical testing, Cell Therapies offers a true ‘needle-to-needle’ service for clients- reaffirming its advanced capabilities in this cutting edge space. <Ends>
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