At the core: good manufacturing practice facility
By Betty Zou
When the current good manufacturing practice (cGMP) facility opens later this year, Sunnybrook Research Institute (SRI) will join an elite group of academic hospitals with the capability of making therapeutic products for clinical testing. Part of the Centre for Research in Image-Guided Therapeutics, the cGMP facility is an essential step in translating preclinical findings to patients.
Dr. Nickett Donaldson-Kabwe is the manager of the cGMP facility. “The need for such a facility is great,” she says. “It was built to help bridge the gap between bench research and the clinic. Researchers within or outside SRI can now manufacture novel, innovative and promising therapeutic products for first-in-human studies here.” Such studies are a priority at SRI.
The main goal of the facility is to help researchers develop cellular therapies like recombinant proteins, antibodies and stem cell products in a strictly controlled, government-regulated environment. This helps to ensure that quality is built into the therapies as safe, pure and effective products are necessary for clinical testing. These therapies can be used to treat and monitor conditions like diabetes, burn injury and cancer. Because the products will be given directly to patients, the cGMP facility must comply with strict Health Canada guidelines. These include regulations on documentation, clean room standards, product processing, how rooms and equipment should be cleaned, and quality control and assurance measures.
The facility features four ISO 6/Class 1000 clean rooms, each equipped with biosafety cabinets, CO2 incubators and, depending on the researcher’s needs, other specialized equipment such as a cell sorter.
The cGMP lab was funded by the Canada Foundation for Innovation. Learn more about the facility by visiting sunnybrook.ca/research/cerigt. To request a consultation, send an email to nickett.donaldson-kabwe@sunnybrook.ca.
