Gene and Cell Medicine Facility
The Gene and Cell Medicine Facility is a state-of-the-art cell manipulation and gene therapy formulation facility built to comply with the rigorous Therapeutic Goods Administration (TGA) code of Good Manufacturing Practice (cGMP).
The Facility is comprised of 11 rooms and a main corridor. It houses three independent clean rooms which meet the strict PICS Class B clean room standard. Each has a dedicated Class C airlock linked to a central Class D workroom accessed via a restricted-access Class D entry airlock. One clean room also has an additional Class C airlock which acts as a “sink”, under negative pressure, and provides the added advantage of bio-containment in concert with asepsis. The restricted-access entry airlock is linked to a feeder corridor which also provides access to a dedicated storage room and data management room. The Facility meets the PC2 bio-containment requirements of the Gene Technology Act 2000.
Cleanliness in the Facility is maintained by terminal HEPA filtration of incoming air and carefully configured pressure gradients between rooms within the Facility to provide a unidirectional flow of air from cleanest to least clean. The entire Facility is constantly monitored for correct temperature and humidity, with all equipment being linked to a centralised building maintenance system which is under constant computerised and pager linked surveillance. In addition the Facility has access to the services of both a Quality Officer and Building Engineer. They play a key role in ensuring that the integrity of the clean rooms is maintained.
The Facility’s primary purpose is to provide the high-tech infrastructure necessary to carry out novel and ground-breaking cellular therapies to benefit children. This includes but is not limited to gene therapy clinical trials. One of the key challenges in gene therapy is to safely repair or replace faulty genes with healthy ones in a sufficient number of cells to achieve therapeutic benefit. This involves the use of cutting-edge gene delivery technologies and manipulation of patient cells that can only be achieved with access to specialised facilities such as these. Use of the Facility is open to both Hospital and industry-based researchers.
Information regarding the Facility and access can be obtained by emailing or by phoning (02) 9845 1316.