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Q-Gen is a fully integrated facility for translational research within QIMR Berghofer providing GMP standard manufacturing facilities for translating QIMR Berghofer’s clinical research to the bedside. These facilities are also available for external researchers and organisations requiring clean room facilities for GMP manufacture.
The Q-Gen facility has 1000m² of dedicated floor space within the Clive Berghofer Cancer Research Centre at Herston. It comprises a general testing laboratory, office space, storage rooms and up to 13 clean rooms, 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 facility are access controlled.
Q-Gen is licensed by the TGA (Licence # 174586) and provides a range of services in addition to clean room lease. These include:
- GMP, or research grade, cell storage at temperatures ranging from -190°C to room temperature
- Quality control testing; including sterility, mycoplasma and cell viability
- Records management
- Stock control
- Documentation development
- Leading clinical research, project management and quality management advice.
Along with clean room lease, Q-Gen 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 hour monitoring and recording of the equipment parameters through our building management system.
Capitalising on the expertise of QIMR Berghofer investigators, Q-Gen is building a solid track record in adoptive T cell therapies for Phase I clinical trials. Q-Gen was also the site of manufacture of the first human embryonic stem cell line to be generated under cGMP.