The Biologics Manufacturing Centre on the NRC's Royalmount Avenue site in Montréal is a new end-to-end biomanufacturing facility that will be used to manufacture vaccines and other biologics.
Construction of the new Biologics Manufacturing Centre was completed in June 2021, only 10 months after breaking ground. Installation of critical equipment continues, and a number of further steps are still required for Health Canada to license the facility, enabling the production of vaccines for human use.
Once it is fully licensed and operational, the Biologics Manufacturing Centre will be able to produce cell-based biopharmaceuticals like vaccines and other biologics, including viral vector, protein subunit, virus-like particles, and other recombinant proteins.
The Government of Canada signed a memorandum of understanding with Novavax in February 2021 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.
The NRC is continuing to work with Novavax, Inc. to produce their COVID-19 vaccine at the Biologics Manufacturing Centre, once both the vaccine candidate and the facility receive Health Canada approvals.
Several steps will be required before actual vaccine production can begin. Each of these steps must be customized for the specific vaccine that will be produced:
- Technology transfer – to establish the process of making the specific vaccine in the facility
- Process qualification – to ensure the process will produce the specific vaccine with precisely the same quality in every dose
- Health Canada approval – regulatory checks to ensure the specific vaccine, produced with the specific process, in the specific facility will result in precisely the same quality in every dose
These customized processes and approvals are an essential part of ensuring the vaccines being produced are consistently safe and effective for Canadians to use.
Biologics, including vaccines and therapeutics, are derived from living cells created with biotechnology, and used to prevent, treat, and cure many human diseases.
Good manufacturing practices (GMP) 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.
Once operational and Good Manufacturing Practices (GMP)-certified, the Biologics Manufacturing Centre will:
- support the manufacturing of vaccine candidates and/or biologics in response to the current and future pandemics
- ensure Canada is prepared to safely manufacture large quantities of vaccines using good manufacturing practices
- ensure the Government of Canada can access and supply future vaccines in Canada for Canadians
- support growth of Canada's biomanufacturing production capacity, knowledge transfer and collaboration.
Once it is GMP-certified, the Biologics Manufacturing Centre will have a production capacity of approximately 4,000 litres per month. Based on 500 doses/L, this would translate into approximately 2 million doses of a vaccine per month. The number of doses will vary widely depending on the specific vaccine and its manufacturing yield.
On August 31, 2020, the Prime Minister and Minister of Innovation, Science and Industry announced the Government of Canada's investment of $126 million for the NRC to design, construct, commission and qualify the Biologics Manufacturing Centre. An additional investment of $20 million will be made annually to offset the operating costs of the new facility.