The NRC is preparing to manufacture COVID‑19 vaccines in Canada for Canadians, with construction in progress on a new Good Manufacturing Practices compliant Biologics Manufacturing Centre on Royalmount Avenue, in Montréal.
Increasing biomanufacturing capacity
On August 31, 2020, Prime Minister Justin Trudeau and Navdeep Bains, Minister of Innovation, Science and Industry announced the Government of Canada's investment of $126 million to design, construct, commission and qualify a new biomanufacturing facility adjacent to its Royalmount site in Montréal. An additional investment of $20 million will be made annually to offset the operating costs of the new facility
Photo credit: Adam Scotti
Photo credit: Adam Scotti
This new biomanufacturing facility, called the Biologics Manufacturing Centre, will support the manufacturing of vaccines and other biologics now and in the future.
Construction is on schedule and is aimed to be completed by end of July 2021. This includes the interior design and fit-up, Good Manufacturing Practices (GMP) commissioning and qualification of the equipment and facility.
On February 2, 2021, Prime Minister Justin Trudeau announced the Government of Canada signed a memorandum of understanding with Novavax to pursue options to produce its COVID‑19 vaccine at the Biologics Manufacturing Centre once both the vaccine candidate and the facility receive the required Health Canada approvals. The Novavax vaccine candidate, NVX-CoV2373, is a protein subunit vaccine.
When it is complete, the new Good Manufacturing Practices (GMP)‑compliant Biologics Manufacturing Centre will:
- support the manufacturing of vaccine candidates for emergency use, once a COVID‑19 vaccine is approved by Health Canada and becomes available
- ensure the Government of Canada can access and supply future vaccines in Canada for Canadians
- ensure Canada is prepared to safely manufacture large quantities of vaccines using GMP
- support and grow Canada's biomanufacturing production capacity, knowledge and collaboration
Once it is GMP-certified, the Biologics Manufacturing Centre would have a production capacity of approximately 4,000 litres per month, which translates to approximately 2 million doses of a vaccine per month. The number of doses produced can vary dramatically depending on the specific vaccine and the manufacturing platform, as well as the complexity of the manufacturing process.
As soon as a Health Canada-approved vaccine candidate is identified for production in the Biologics Manufacturing Centre, the required technology transfer will occur to enable the production of a specific vaccine, followed by the necessary qualification of the process, and Health Canada approvals. This customized approach for technology transfer, revalidation, and product-specific Health Canada approval will be needed before actual vaccine production can commence.
For potential treatments or vaccines to be tested in human beings, they must be manufactured in a controlled environment that is compliant with GMP, which ensure drugs meet the quality standards appropriate to their intended use before they are sold. More information on GMP can be found on the Health Canada website.
Learn more about the Biologics Manufacturing Centre
The Biologics Manufacturing Centre under construction at the NRC's Royalmount site. (February 2021)
The Biologics Manufacturing Centre under construction at the NRC's Royalmount site. (February 2021)
Building a permanent clinical trial material facility at Royalmount
The NRC is also building a new GMP-compliant clinical trial material facility at the Royalmount site in Montréal that will be operated by the NRC’s Human Health Therapeutics Research Centre.
The NRC is completing the final design and engineering work for this facility to support vaccines and biologics research and development.
The clinical trial material facility will have a maximum bioreactor capacity of 500 litres per month. The number of doses will vary widely, depending on the type of vaccine and its manufacturing yield.
The NRC has purchased and received equipment such as single-use 50-litre and 500-litre bioreactors. Work on quality assurance process and framework is well underway. This involves putting in place quality assurance protocols, preparing documentation, training staff, and more.
When complete, this facility will be able to produce small-batch clinical trial materials from cell-based biologics production, including platforms such as viral vector, protein subunit, virus-like particles and other recombinant proteins.
When a vaccine candidate is ready for clinical trials in humans, a customized approach for technology transfer, validation, and product-specific Health Canada approval is needed before actual materials can be produced for clinical trials.
Key facts: The NRC’s Clinical Trial Material Facility and Biologics Manufacturing Centre
| Clinical Trial Material Facility | Biologics Manufacturing Centre | |
|---|---|---|
| Funding / Purpose | $44M to design, construct, commission and qualify a GMP-compliant permanent clinical trial material facility to de-risk and accelerate vaccine development | $126M to design, construct, commission and qualify a new GMP-compliant end-to-end biomanufacturing facility to produce vaccines and other biologics |
| Location | On the NRC’s Royalmount site in Montréal | On the NRC’s Royalmount site in Montréal |
| Planned Operations | Manufacturing vaccines and other biologics materials for clinical trials | Manufacturing vaccines and other biologics for large-scale human use |
| Status | Equipment procured, staff training and procedures underway, completing final design and engineering work | Under construction |
| Construction scope |
Construction will include:
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Construction will include:
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| Expected completion of construction | To be determined once final design and engineering work is completed | End of July 2021 |
| Technology transfer | A customized approach for technology transfer, revalidation, and product-specific Health Canada approval will be needed before actual vaccine production can begin | |
| Good manufacturing practice compliance | Planned; has not yet been submitted for Health Canada approval | |
| Vaccine type | Cell-based biologics – i.e. viral vector, protein subunit, virus-like particle based materials for clinical trial | Cell-based biologics – i.e. viral vector, protein subunit, virus-like particle based vaccine doses |
| Manufacturing capacity | Bioreactor capacity of approximately 500 litres per month | Bioreactor capacity of approximately 4,000 litres per month |
| Number of doses | The number of doses will vary widely depending on the type of vaccine, the manufacturing platform and process as well as its yield | |
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Based on information of general yields available for other products, a conservative estimate is 500 doses/L/month. This could translate to up to 250,000 doses per month of vaccine materials for clinical trials |
Based on information of general yields available for other products, a conservative estimate is 500 doses/L/month. This could translate to approximately 2 million vaccine doses per month |
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Project spotlight: NRC researchers mobilize to advance vaccine technologies against COVID-19
The NRC is working with trusted partners as part of collective efforts to help find solutions to the COVID-19 outbreak. We're working with collaborators at VBI Vaccines (based in Massachusetts, with research operations in Ottawa, and VIDO-InterVac (based at the University of Saskatchewan).