Biologics Manufacturing Centre

 

The Biologics Manufacturing Centre is a new end-to-end biomanufacturing facility to support growth of Canada's biomanufacturing production capacity for the future, ensuring that vaccines and other biologics can be safely manufactured here at home.

Readying for production

Learn more about how the NRC is readying the Biologics Manufacturing Centre, both for licensing and vaccine production.

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About the facility

The NRC was mandated by the Government of Canada to establish the new Biologics Manufacturing Centre at our Royalmount site in Montréal, Québec.

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 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.

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.

It 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.

Key features

  • Full end-to-end manufacturing capabilities, from scale-up to secondary packaging
  • Flexible physical configuration
  • 2 individual production lines
  • Filling suite
  • GMP-compliant

Facility characteristics

  • Approximately 5,400 square metres/ 58,000 square feet
  • Critical heat, ventilation and air conditioning (HVAC) systems
  • Critical purified water and water-for-injection (WFI) systems
  • Large quality-control laboratory space
  • Cold-room storage
  • Large warehouse area

Specialized equipment

  • Bioreactors: 50 L, 200 L, 500 L, 2000 L
  • Chromatography and tangential filtration equipment
  • Aseptic filling equipment

Construction and fit-up complete

Construction of the new Biologics Manufacturing Centre was completed in June 2021, only 10 months after breaking ground. This was achieved through an accelerated construction process, which allowed for a condensed construction schedule, while still addressing all of the many details required to ensure the facility meets GMP compliance.

A number of complex processes are now underway to ensure the facility can be licensed by Health Canada, enabling the production of vaccines for human use.

Funding

On August 31, 2020, the Prime Minister and the 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.

First vaccine sponsor

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.

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.

Consultation and project advisory board

Stakeholder consultations with a range of organizations, as well guidance from technical, business and other experts, 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. Learn more about our consultations and our project advisory board.

Definitions

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) are the quality assurance processes that ensure products are consistently produced and controlled to meet the quality standards appropriate to their intended use and as required by the product specification before they are approved for commercial use. More information on GMP can be found on the Health Canada website.