Drug establishment licence issued!

- Ottawa, Ontario

Along with physical construction of the building, one of the most significant milestones in establishing a new biomanufacturing facility is the confirmation of its compliance with the rigorous safety and quality standards of good manufacturing practices (GMP).

This confirmation comes in the form of a drug establishment licence that demonstrates GMP compliance and is required for all new drug production facilities in Canada. It's an important step in readying a new biomanufacturing facility for commercial production.

The preparation

The operations team at the Biologics Manufacturing Centre spent months preparing for a Health Canada inspection, where experts assess the facility's compliance with GMP standards for domestic drug production.

The Biologics Manufacturing Centre's preparation stage included completing all the technical steps and activities related to the commissioning, qualification and validation process, as well as all related testing and GMP-required documentation for more than 50 rooms and more than 250 pieces of equipment.

Teams at the Biologics Manufacturing Centre also defined, developed, reviewed and formalized more than 600 standard operating procedures and related documents, which are critical to establishing, maintaining and operating a GMP-certified facility.

All staff and anyone involved in the operations of the facility were also trained on the standard operating procedures and related documents.

The results are in

All that hard work and dedication was put to the test in July 2022, when Health Canada experts spent 5 days inspecting the Biologics Manufacturing Centre. They covered everything from the physical equipment and how it will be used; to the extensive cleaning practices; to how materials enter, leave and are stored in the facility.

The Health Canada inspection resulted in a compliant rating for the Biologics Manufacturing Centre, which confirms the facility is complying with good manufacturing practices and the Food and Drugs Act. It authorizes the facility to produce drugs for human use.

Important milestone

NRC President Iain Stewart sees this milestone as particularly meaningful in establishing the facility. "Receiving the Biologics Manufacturing Centre's drug establishment licence in record time is a significant accomplishment. It is the result of the strong work and commitment of our highly skilled team. The Biologics Manufacturing Centre is now fully equipped, commissioned and began in early August producing engineering run batches for its first client, in preparation for domestically producing vaccines for the current pandemic, and well beyond."

The NRC has not been working alone. Ongoing collaboration across the Government of Canada, and with the facility's first client, has been essential to establishing the facility, while also preparing for its first production.

"Novavax is proud to be the first client of this new GMP-compliant Canadian biomanufacturing facility. We look forward to manufacturing our COVID-19 vaccine, Nuvaxovid™, which was authorized by Health Canada, domestically for the people of Canada. We congratulate the Biologics Manufacturing Centre team for implementing this state-of-the-art technology and reaching this major milestone," says Stanley C. Erck, President and Chief Executive Officer, Novavax.

Looking ahead

While licensing is a critical milestone in readying the Biologics Manufacturing Centre for vaccine production, inside the facility, the team continues to work diligently toward the next important milestones – completing the engineering runs and then producing process performance qualification batches for the first vaccine client.

Photos inside the Biologics Manufacturing Centre.


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