Q-Gen Cell Therapeutics is a fully integrated facility for translational research within QIMR Berghofer providing GMP manufacturing facilities for translating QIMR Berghofer’s clinical research to the bedside. These facilities are also available for external researchers and commercial organisations requiring cleanroom facilities.
The Q-Gen Cell Therapeutics facility has over 2,500 m² of dedicated floor space within the Clive Berghofer Cancer Research Centre. It comprises an in-house quality control testing laboratory, office space, storage rooms and up to 13 cleanrooms, available to meet ISO Class 7 and PC2 standard, with dedicated air handling units for the majority of rooms. All rooms within the Q-Gen Cell Therapeutics facility are access controlled, including 24 hr on-site security.
Q-Gen Cell Therapeutics is licensed by the TGA (Licence # MI-1112004-LI-000153-1) and provides a range of services in addition to cleanroom lease. These include:
- microbiological and immunobiological testing; including Sterility, Endotoxin, Mycoplasma, Phenotyping and cell viability
- GMP, or research grade, controlled storage facilities at temperatures ranging from -190°C to room temperature
- stock management
- documentation development and control
- leading clinical research, project management and quality management consulting.
In addition to cleanroom lease, Q-Gen Cell therapeutics can also provide a range of cell processing and research equipment, maintained and validated for GMP use. All critical equipment is continuously connected to an independent back-up power generator, which includes 24 hr monitoring and recording of the equipment parameters, through our building management system.
Capitalising on the expertise of QIMR Berghofer investigators, Q-Gen Cell Therapeutics has a solid track record in adoptive T cell therapies for Phase I and Phase II clinical trials. To discuss potential collaborations or leasing opportunities please contact the Q-Gen Cell Therapeutics Facility Manager, Darron Laing at email@example.com or (07) 3845 3851.