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
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 July 2021. This includes the interior design and fit-up, Good Manufacturing Practices (GMP) commissioning and qualification of the equipment and facility.
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.
Upgrading the clinical trial material facility at Royalmount
The NRC's Human Health Therapeutics Research Centre is also upgrading the existing Royalmount building to set up a new GMP-compliant clinical trial material facility with a single-use bioreactor capacity of 500 litres.
The actual number of doses will vary widely depending on the type of vaccine candidate being produced, and their manufacturing yield. Taking a conservative approach, based on information of general yields available for pre-COVID-19 products, the bioreactor capacity of 500 litres could translate to up to 250,000 doses per month of materials for clinical trials of vaccines on platforms such as viral vector, protein sub unit, virus like particles, and recombinant protein.
To achieve GMP-compliance for the clinical trial material facility, the existing building requires physical modifications, equipment, and all of the steps under the GMP certification and validation process. Work on these aspects is underway.
The NRC has already purchased and received single-use 50-litre and 500-litre bioreactors, and work on quality assurance process and framework is well underway. This involves putting in place quality assurance protocols, preparing documentation, training staff, and validating equipment and space.
All of this work is expected to be complete by mid-2021.
For a vaccine candidate needing clinical trial material a customized approach for technology transfer, validation, and product-specific Health Canada approval will be needed before actual vaccine production for clinical trials can commence.
Key facts: NRC Royalmount Clinical Trial Material Facility and New Biologics Manufacturing Centre
Clinical Trial Material Facility
|Biologics Manufacturing Centre|
|Funding / Purpose||$44M upgrade to the NRC's existing Royalmount facility to establish biomanufacturing for vaccine clinical trial material, and to de-risk and accelerate vaccine development||$126M to design, construct, commission and qualify a new GMP compliant end-to-end biomanufacturing facility adjacent to the NRC's existing Royalmount facility|
|Planned Operations||Producing material for clinical trials||Manufacturing of vaccines and other biologics|
|Status||Under Construction||Under Construction|
To achieve GMP compliance for the clinical trial material facility, the existing building requires:
Construction of this brand new facility will include:
|Expected completion||Mid-2021||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 commence|
|Good manufacturing practice compliance||Planned, has not been submitted for Health Canada approval||Planned, has not been submitted for Health Canada approval|
|Vaccine type||Will be able to produce viral vector-based, protein subunit, virus-like particle based (mammalian-cell based biologics) materials for clinical trial||Will be able to produce viral vector, protein subunit, virus-like particle based (mammalian-cell based biologics) vaccine doses|
|Manufacturing capacity||Bioreactor capacity of 500 litres per month||Bioreactor capacity of 4,000 litres per month|
|How many doses?||The number of doses will vary widely depending on the type of vaccine, the manufacturing platform and process as well as its yield|
|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 2,000,000 vaccine doses per month|
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).