Canadian manufacturing of CAR-T cells a game-changer for cancer patients and researchers

More than a dozen cancer patients are alive and cancer-free thanks to a pioneering clinical trial using made-in-Canada CAR-T cells.

The new trial, called Canadian-Led Immunotherapies in Cancer-01 (CLIC-01), is the first to manufacture CAR-T cells in Canada. It is paving the way to less expensive and more accessible treatments for patients.

CLIC-01 uses CAR-T therapy to treat patients with specific kinds of leukemia or lymphoma who were given just months to live. This June, The Ottawa Hospital announced that of 30 of these patients treated so far, 13 had no more cancer cells detected in their blood.

The trial was made possible thanks to The Ottawa Hospital’s Biotherapeutics Manufacturing Centre (BMC), a one-of-a-kind facility established in 2006 that manufactures biologics, also called “living drugs.” It is the first in Canada to manufacture two types of biologics – viruses and cell products – side-by-side. BMC’s Virus Manufacturing Facility and its Cell Manufacturing Facility are housed on the same campus.

CAR-T (chimeric antigen receptor T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy. CAR-T cells bind to cancer cells and kill them.

Dr. Jennifer Quizi is Director of the BMC Virus Manufacturing Facility. “CAR-T therapy is one of the most complex processes and, for it to work, two very different biologics have to come together,” Quizi said in an interview.

“We’re unique in that we have access to both virus and cell manufacturing, which is uncommon. This allows us to manufacture products such as CAR-T cells developed by our researchers. Without this capacity, we could not deliver this treatment to Canadians.”

The first CLIC-01 clinical trial launched in 2019 at The Ottawa Hospital and at BC Cancer, with support from the BioCanRx network, BC Cancer, The Ottawa Hospital Foundation and the Ontario Institute for Cancer Research. Researchers from both Ottawa and British Columbia came together to develop every aspect of the therapy, including how to manufacture it, ensure its quality, administer it to patients and ensure sufficient funding.

“We have this kind of Canadian brain trust in place to support CAR-T therapies,” explains Quizi. “Our hope is we can create even more specialized sites that can manufacture these cell products. That way, we can expand equitable access to these very complex, personalized therapies in Canada.”

Along with CAR-T cells, the Biotherapeutics Manufacturing Centre has manufactured more than a dozen other cell and virus-based products. These include stem cells for heart and lung disease, gene therapy for rare diseases, cancer-fighting viruses and, more recently, therapies and vaccines to fight COVID-19. BMC’s therapies have been used for human clinical trials in Canada, the United States, Europe and Asia.

“Our strength is that we’ve been doing this for 15 years and we’re very nimble,” says Quizi. “We have processes in place and can offer affordable access to manufacturing for early-phase clinical trials, which can otherwise be extremely expensive. We can make products that otherwise might not be possible and provide timely access to cutting-edge therapies.”

Hands-on training offered in biotherapeutics manufacturing

BMC was first funded by the Canada Foundation for Innovation and The Ottawa Hospital Foundation, which both continue to provide major support, primarily for its equipment.

BioCanRx, a Canadian network focused on accelerating cancer therapies, has provided important operational grants. BMC also receives revenue from universities, pharmaceutical companies and startups. The Canada Foundation for Innovation’s $5-million investment in BMC to date has been leveraged at least tenfold by investments from other sources, and has fostered more than five startup companies, which continue to invest in Canadian research and innovation.

The Centre has eight manufacturing suites and 40 full-time staff. It also leads the only hands-on training program in Canada in biotherapeutics manufacturing – in partnership with Algonquin College, the University of Ottawa and Mitacs. The innovative training program was developed by Quizi in response to the need for highly skilled personnel in the BMC facility and others like it.

“The biomanufacturing sector is starting to take hold in Canada, with significant investments by the Government of Canada to help ensure that biomanufacturing becomes a very robust, Canadian enterprise,” Quizi says. “But we don’t have the programs in place to train the highly qualified personnel required for success.

“We recognized this before the pandemic and that’s why we created the hands-on biomanufacturing program called CanPRIME [the Canadian Partnership for Research in Immunotherapy Manufacturing Excellence],” she notes. “We invite university and college students to come on site with paid eight-month internships and see what it’s like to work in the BMC facility.”

Quizi is now leading CanPRIME’s expansion to the national level with financial and logistical support from BioCanRx. It aims to train more than 80 participants over the next five years at one of five partner facilities across Canada – in Ottawa, Toronto, Winnipeg, Edmonton and Victoria.

“I can’t emphasize enough how important these sorts of facilities are, and we’re looking forward to seeing more of them in Canada,” Quizi says. “Of course, it will take time for us to build the physical capacity that we need to become one of the leading countries in biologics manufacturing in the world. Pivotal to that is ensuring that we have a pipeline of highly qualified personnel, so we have the people we need to produce these highly complex therapies for Canadians.”

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