The Biologics Manufacturing Centre, a new, end-to-end biomanufacturing facility currently under construction on the NRC's Royalmount Avenue site in Montréal, will be used to manufacture COVID-19 and other vaccines and biologics.
Construction of the new facility is on schedule to be completed by end of July 2021, including the interior design and fit-up, good manufacturing practices (GMP)‑commissioning and qualification of the equipment and facility.
The Biologics Manufacturing Centre will be capable of manufacturing biopharmaceuticals from cell‑based biologics production. This includes vaccines on platforms such as viral vector, protein subunit, and virus-like particles, as well as other recombinant proteins.
Once a Health Canada-approved vaccine candidate is identified for production in the Biologics Manufacturing Centre, 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.
When it is complete, the 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 good manufacturing practices
- support and grow 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.
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.
With construction of the Biologics Manufacturing Centre well underway, the NRC is consulting with stakeholders in the biomanufacturing sector to gather valuable input into future plans for the centre, including its eventual operation as a public-private partnership and the process for securing an organization to operate it.
These stakeholder consultations will help inform the NRC in developing the governance and operational model for the Biologics Manufacturing Centre, and ensure it adheres to industry best practices, and ultimately provides the maximum benefit to Canadians.
The consultation includes representatives from a range of organizations in the biomanufacturing sector, such as contract manufacturing organizations, contract development and manufacturing organizations, biopharmaceutical companies and academia.