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 has been readying the Biologics Manufacturing Centre, both for licensing and vaccine production.

About the facility

The NRC was mandated by the Government of Canada to establish the new good manufacturing practices (GMP)-certified Biologics Manufacturing Centre at our Royalmount site in Montréal, Quebec.

An important contribution to Canada's biomanufacturing infrastructure, the Biologics Manufacturing Centre:

supports the manufacturing of vaccine candidates and/or biologics in response to the current and future pandemics.
ensures Canada is prepared to safely manufacture vaccines using good manufacturing practices.
ensures the Government of Canada can access and supply future vaccines in Canada for Canadians.
supports growth of Canada's biomanufacturing production capacity, knowledge transfer and collaboration.

The Biologics Manufacturing Centre is designed to produce biopharmaceuticals like viral vector, protein subunit, and virus-like particle vaccines and other biologics.

It has 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 operationalization

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.

Following an inspection of the Biologics Manufacturing Centre, Health Canada issued the facility's drug establishment licence in August 2022. This licence demonstrates the facility's compliance with good manufacturing practices, which ensure the safety of vaccine production for humans.

In preparation for the Health Canada inspection, the Biologics Manufacturing Centre undertook the complex process of completing the required commissioning, qualification and validation activities for more than 50 rooms and more than 250 pieces of equipment in the facility.

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.

First project – Manufacturing Nuvaxovid™ vaccine

The Biologics Manufacturing Centre is working with its first client, Novavax Inc. on the technology transfer required to produce the company's COVID-19 vaccine, Nuvaxovid™ in the facility.

The production timeline of the Novavax COVID-19 vaccine is proceeding as expected, with smaller-scale technology transfer completed in early 2022, and full-scale engineering runs underway at the Biologics Manufacturing Centre. Engineering runs will be followed by regular facility equipment maintenance in accordance with GMP requirements.

Once Novavax approves the results of 3 engineering batches and the equipment maintenance is complete, process performance qualification batches for drug substance production can begin at the Biologics Manufacturing Centre.

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.

Governance

From the outset, the intent has been for the Biologics Manufacturing Centre to be self-contained and governed through a public-private partnership.

To that end, in December 2022, the NRC and the Centre for Commercialization of Regenerative Medicine (CCRM) as founding members, jointly set up a new legal independent not-for-profit corporation, Biologics Manufacturing Centre (BMC) Inc., to govern the facility's operations.

Consultation and project advisory board

Stakeholder consultations with a range of organizations, as well guidance from technical, business and other experts, have helped 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.