If you had been walking along Royalmount Avenue in Montreal one sunny day in late July of 2020, you might have noticed a few people standing on the National Research Council of Canada's (NRC) property, staring intently at a grassy green field and wondered what they were seeing.
In that very spot, almost exactly 2 years later, the fully constructed Biologics Manufacturing Centre received its drug establishment licence, certifying the new facility's compliance with good manufacturing practices (GMP) to be able to produce vaccines and other biologic medicines for human use.
A specific task and a defined role
The NRC was tasked, on behalf of the Government of Canada, to create something unique in Canada, a biomanufacturing facility intended specifically for public-good projects. Its dual purpose is to produce biologics that would not otherwise be available for Canadians and to pivot during a public health emergency to produce cell-based vaccines or other drugs needed to keep Canadians safe.
The NRC's role was to lead the facility's construction, and get it ready for use as quickly as possible, while adhering to all the requirements for GMP production. With the construction complete and the drug establishment licence issued, the NRC has fulfilled that leadership role.
As Canada's federal research and development organization, the NRC's overall mission is to find solutions to Canada's biggest challenges. Establishing the Biologics Manufacturing Centre fell within that mandate. With the facility now set up to operate, the next chapter is planning for its operations into the longer term, outside of the NRC.
CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, was selected following a nation-wide open call for proposals to work with the NRC to jointly set up a not-for-profit corporation to operate the Biologics Manufacturing Centre.
On April 1, 2023, the not-for-profit corporation, Biologics Manufacturing Centre (BMC) Inc., officially assumed responsibility for the operations of the Biologics Manufacturing Centre.
As an independent not-for-profit corporation Biologics Manufacturing Centre (BMC) Inc. operates as a contract manufacturing organization, with a public-good mandate: to respond to pandemic and other health emergency preparedness needs, support public-interest projects and contribute to the growth and resilience of Canada's life sciences sector.
The NRC's ongoing role
With the transition of operations, the NRC's leading role in establishing the Biologics Manufacturing Centre project is complete. The NRC continues to own the infrastructure, on behalf of the Government of Canada, and act as lessor of the building and equipment to Biologics Manufacturing Centre (BMC) Inc.
The NRC is also providing annual funding to ensure the facility is maintained in a GMP readiness state and prepared to respond to a public health emergency, when and as required.
More work to be done
In parallel with the design and construction of the facility, the NRC also led the establishment of a collaboration with the facility's first client, Novavax. Working with Novavax, the NRC successfully completed the complex technology transfer for this project, with engineering runs completed in the winter of 2022. The manufacturing of process performance qualification batches is expected to begin this spring.
There is still much work to be done at the Biologics Manufacturing Centre, including continuing the first client project and continuing to establish a client base focused on new public-good projects to benefit Canadians. That work will now be overseen by Biologics Manufacturing Centre (BMC) Inc.
Challenge accepted—mission complete
Looking back on that hot summer day in 2020, the NRC employees standing in that field couldn't possibly have imagined the challenging road ahead: an accelerated construction schedule, strict regulations for GMP compliance, pandemic-related restrictions, supply and demand concerns for critical materials, ever-changing timelines and a client project that was well underway before construction was even completed. Establishing the Biologics Manufacturing Centre was a complex project.
But with the new infrastructure in place, leading-edge equipment installed and an experienced team assembled, Canada is now in a much better position to protect the health of Canadians going forward.
That was the NRC's assignment. With its completion, a new chapter begins as Biologics Manufacturing Centre (BMC) Inc.
Read other stories in this series to learn more.