QIMR Berghofer Medical Research Institute has been granted approval by the Therapeutics Goods Administration (TGA) to manufacture cellular therapies for human use, opening the way for clinical trials of new cancer treatments.
QIMR Berghofer’s manufacturing facility, Q-Gen, is the first in Australia to be granted regulatory approval to prepare clinical grade T-cell therapies.
The announcement has been made by Queensland Premier Annastacia Palaszczuk in Philadelphia at the Bio International Convention, the world’s biggest biotechnology event.
““This is a huge step forward that will put the focus on Queensland and QIMR Berghofer as a global leader in the fight against cancer,” Ms Palaszczuk said.
The TGA, Australia’s equivalent of the Food and Drug Administration (FDA) in the United States, is responsible for licencing facilities according to stringent quality and hygiene standards.
QIMR Berghofer Director and CEO Professor Frank Gannon said the approval enables the Institute to initiate new clinical trials of new cancer immunotherapies.
“This approval will allow Q-Gen to prepare therapeutics including cytotoxic T-cell therapies for patients with cancers such as glioblastoma multiforme (GBM) and nasopharyngeal carcinoma (NPC),” Professor Gannon said.
“QIMR Berghofer is focussed on producing research with outcomes beyond the laboratory, and this is an excellent example of our efforts to get laboratory discoveries through clinical trials and to the hospital bedside.”
New cancer treatments, developed in the laboratory of QIMR Berghofer’s renowned tumour immunologist Professor Rajiv Khanna, take the patient’s immune cells from the blood and train them to recognise antigens that are found in particular cancers.
Once trained, the cells are re-infused back into the patient to attack the cancer.
Preliminary trials have shown the therapy is safe, has no major side effects and can be effective against virus-specific tumours.
Professor Gannon said Q-Gen has a strong commercial track record and continues to work with industry in the manufacture of therapies to Good Manufacturing Practice (GMP) standards.
• Research-grade cell storage
• Quality control testing; including sterility, mycoplasma and cell viability
• Records management
• Stock control
• Documentation development
• Leading clinical research, project management and quality management advice
QIMR Berghofer is located in Brisbane’s key medical precinct at Herston, and also includes the clinical trials facility Q-Pharm.
Ms Palaszczuk said making the announcement at one of the world’s biggest biotechnology events was the perfect way to help build Queensland’s growing medical research reputation.
“We already have some of the world’s best scientists and best facilities, but announcements like this can have a ripple effect when it comes to attracting more scientists and more investment,” Ms Palaszczuk said.