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Rebuilding the Canadian biomanufacturing sector

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Artist’s drawing of how CCRM’s biomanufacturing facility at McMaster Innovation Park could look

From the H1N1 pandemic of 2009, Canada recognized it was not ready for a pandemic. “What we were not prepared for was for the pandemic to occur when it did,” said an interviewee at a panel review of Canada’s response to the 2009 H1N1 pandemic. “So, it caught us off guard in that it occurred when it did, that it started where it started in the world, that the strain was what it was. So not everything we would have liked to have had in place was in place.”

The problems noted in 2009, however, happened again in 2021, amidst the global COVID-19 pandemic. Limited manufacturing capabilities, confusing vaccine distribution, and general lack of preparedness have hampered the Canadian response to this pandemic. This has Canada on the sidelines, forcing dependence on foreign nations whose priority remains with their own citizens.

“What you’ve seen for the last 20 years is an annual decline year by year of private business sector R&D [Research and Development],” explains Dr. Dan Breznitz, a Professor and Munk Chair of Innovation Studies, in the Munk School of Global Affairs & Public Policy. “It has been a very long process with not just manufacturing, but also the lowering of innovation.”

Since 2001, this decline of investment in R&D has meant that Canada has fallen behind among peer nations.

“We’re a country that has been driven into wealth by having lots of resources and selling them,” explains Dr. Michael May, President and CEO, CCRM, a leader in the fields of cellular and gene therapy. “And I think in the life science sector we’ve had a similar approach, with great ideas, great innovation and doing excellent science, but our model has been really to sell our intellectual property or to license it as opposed to thinking about a deeper strategy.”

To rectify Canada’s R&D sector, there needs to be a plan in place to build a critical mass towards sustaining industry. One way to do this, says Dr. May, is to focus on building an ecosystem akin to the one seen in Canada’s auto sector where we manufacture and also have supply chains that are robust and deep.

Another key aspect of building an ecosystem starts with the retention of homegrown talent. “We’ve got to give people good opportunities early in their career, which means we have got to find ways to pay them well and give them exciting opportunities in areas like cell and gene therapy,” explains Dr. May. This is something CCRM has consistently done by attracting talent and clients from across the world, despite being in a field suffering from the all too common brain drain.

Recently CCRM and McMaster Innovation Park (MIP) announced a partnership to build a biomanufacturing campus that will produce the cells and viral vectors required for commercial-scale manufacturing of cell and gene therapies.

“Our partnership with MIP is about more than building a facility,” explains Dr. May. “This is about building domestic manufacturing capacity within the region for the next generation of medical advances. Our expectation is that the biomanufacturing campus within MIP, and the CDMO [contract development manufacturing organization], will result in jobs, economic stimulus for the region and, most importantly, life-saving products for patients. For Canada, our opportunity to be amongst the global leaders in cell and gene therapy is of strategic significance.”

Moving forward, if the focus is on manufacturing capabilities, the key will be versatility. “We have to be strategic about how we can develop a manufacturing infrastructure that’s flexible. We really don’t know what health science crisis or other crisis we’re going to see in the future, so how we create infrastructure and expertise that can pivot will be the focus,” explains Dr. May. Expanding this across several industries will be critical.

Early responses to the pandemic primarily involved the Canadian government strengthening and expanding research and biomanufacturing capabilities through a series of investments totalling over $1 billion dollars. Among the largest was an investment of $126 million for the National Research Council’s (NRC) Biologics Manufacturing Centre in Montréal. With the facility scheduled to be operational by July 2021, this infrastructure will allow for end-to-end vaccine development and the production of two million vaccine doses a month.

Investment in Canadian firms developing COVID-19 therapeutics has also been a priority. Both KABS Laboratories Inc. and Immune Biosolutions are set to receive $54.2 million and $13.5 million, respectively, to expand operations in Quebec for COVID-19 therapeutic antibody development and end stage vaccine production. Through these investments, Canada has begun actively rebuilding its research and biomanufacturing sector. However, these investments only represent one pathway forward.

One current example is Biolyse Pharma trying to license the rights to produce the Johnson and Johnson one-shot vaccine. Through repurposing of Biolyse’s manufacturing equipment, there is the potential to produce 20 million vaccine doses a year. Working alongside the Canadian government, this agreement could expedite vaccine development for Canadians and lower income nations struggling to vaccinate their populations.

The development of a more flexible infrastructure will also make Canada a leader in future industries that can be leveraged for export purposes, explains Dr. May. Using this to develop trade policies that take advantage of economic strengths within a globally fragmented economy would ensure Canada can reclaim its stake as a major player in biotechnology and manufacturing.

Part of this plan will involve continued cooperation with the government to share the cost and risk burden with private investors, incentivizing an increase in R&D investment. Changing policies to make it easier to attract talent, coupled with training incentives, will continue the growth of industry across Canada. Through these efforts, the Canadian economy will have more self-reliance, similar to what’s been seen in peer nations.

“We don’t have to look like Silicon Valley, we can look like Taiwan and think about how good that economy is and [consequently] dealt with COVID-19,” concludes Dr. Breznitz.

 


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