Steps to full production
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.
The Biologics Manufacturing Centre is currently under construction and 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.
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.
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