Cell and gene therapy GMP manufacturing facilities
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 original project design intent was for a different cleanroom system, however due to the backlog in the European supply chain was incredibly delayed so left no alternative other than to change the cleanroom system to the ISO-PHAR cleanroom system. The 15 specialist pass through boxes were supplied by Dagard as intended and were designed to fit flush with the ISO-PHAR wall system.
Cell therapy video showing TPC cleanroom work upon completion.
ISO-PHAR cleanroom system.
The move to the ISO-PHAR cleanroom system on the Cell Therapy project had the following advantages over the alternatives,
- Timeframe for design development and procurement.
- Fire rating. The ISO-PHAR system has the highest cleanroom system fire rating in Australia, along with a very low Smogra rating.
- Chemical resistant facings.
- Fully flush design.
- Multiple service reticulation options.
- Preformed corners for easy cleanability.
- Durability and aesthetics.
