Yesterday, BioCanRx convened a unique workshop to foster Canada’s first fulsome discussion about the regulatory frameworks that govern closed-system manufacturing in Canada. More than 70 representatives from federal government departments and regulators, the research and academic sector, health system organizations, and industry gathered at Health Canada’s Sir Frederick Banting Research Centre for a full day of discussion about how regulatory alignment can help pave the way for innovative new manufacturing processes that challenge key assumptions that the Food and Drugs Act and associated regulations are based upon, and are used for products including cell therapies, RNA therapeutics, vaccines and gene therapies.
“Closed-system manufacturing means that the product being produced is not exposed to the surrounding environment, and material transfers into or out of the system are appropriately controlled,” explained Dr. Erin Bassett, Director of Regulatory Affairs and Policy at BioCanRx.
This sort of manufacturing often involves the creation of a therapy for one patient within a single manufacturing device, such as the Miltenyi Prodigy used by the Canadian-Led Immunotherapies Collaborative (CLIC) to treat more than 100 lymphoma and leukemia patients through the BioCanRx-funded CLIC trials. By enclosing the majority of the process, properly-implemented closed-system manufacturing has the potential to reduce costs and increase access to a range of promising therapies to patients across Canada, while still meeting Health Canada’s safety and quality requirements.
However, this rapidly evolving manufacturing paradigm can engage multiple existing regulatory frameworks in Canada, including those for drug manufacturing, medical device, and transplant regulatory frameworks. As such, researchers and manufacturers seeking to use closed-system technologies must consider these overlapping sets of regulation, which adds cost and can slow or prevent the launch of new clinical trials or the market approval of new products in Canada. Finding ways to coordinate frameworks without reducing the level of regulatory rigour that protects Canadian patients could significantly expand Canada’s capacity to develop these new products, and to compete in a global environment where other jurisdictions are developing bespoke regulatory frameworks to spur innovation.
“Today’s discussion is not about reducing regulatory standards or lowering expectations. Rather, it is about understanding how existing regulatory objectives can continue to be achieved as manufacturing technologies evolve, and whether there may be opportunities to improve clarity, alignment, and shared understanding across the ecosystem.”
BioCanRx will generate a report capturing the workshop’s key findings and will and continue to facilitate dialogue between key research and academic interest holders, health system organizations, industry, international peers, Government of Canada departments and agencies including CIHR, ISED, HERC, PS, PHAC and regulators and policymakers at Health Canada. Undertaking this challenging and complex regulatory work will ultimately strengthen Canada’s drug development system, helping ensure that Canadian innovators can compete on a global stage, and that Canadian patients have greater access to made-in-Canada therapies.
