Biomanufacturing: Infrastructure

The Government of Canada is investing in biomanufacturing infrastructure to enhance our capacity to manufacture domestic and international vaccine and therapeutic candidates as soon as they are available.

One of these strategic investments was $126 million for the National Research Council of Canada to design, construct, commission and qualify a new biomanufacturing facility on its Royalmount site in Montréal. 

Construction of the new Biologics Manufacturing Centre was completed in June 2021, only 10 months after breaking ground. Installation of critical equipment continues, and further steps are still required for Health Canada to license the facility, enabling vaccine production. The license, designated through Good manufacturing practices (GMP), ensures that drugs meet the quality standards before they are sold.

In February 2022, Health Canada announced the authorization of the Novavax COVID-19 vaccine in adults 18 years of age and older. Novavax, Inc. is responsible for obtaining additional regulatory approvals related to the production of their vaccine in the Biologics Manufacturing Centre. There are several steps 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.

Learn more about the steps required to make a new GMP-compliant facility ready for licensing and for making a new vaccine with the National Research Council (NRC)’s Readying the Biologics Manufacturing Centre.

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