COVID-19 response: Building the infrastructure

Increasing biomanufacturing capacity

On August 31, 2020, Prime Minister Justin Trudeau and Navdeep Bains, Minister of Innovation, Science and Industry announced the Government of Canada's investment of $126 million over 2 years to build a BVF. An additional investment of $20 million will be made annually to offset the operating costs of the new facility.

This investment will allow the new facility to produce up to 2 million doses a month by the end of summer 2021. The new GMP compliant BVF will:

• support the manufacturing of vaccine candidates for emergency use as early as summer 2021, once a COVID‑19 vaccine is approved by Health Canada and becomes available
• ensure the Government of Canada can access and supply future vaccines in Canada for Canadians
• ensure Canada is prepared to safely manufacture large quantities of vaccines using GMP
• support and grow Canada's biomanufacturing production capacity, knowledge and collaboration

The construction of the 2‑storey facility adjacent to the Royalmount building is proceeding with 2 key milestones:

• The build-out of the building's shell, which includes excavation, foundation, steel structure and concrete slab. This initial phase of construction is expected to be completed by December 31, 2020
• The build-out of the interior, installation of the equipment, and commissioning and qualification of the facility, which is targeted for completion by July 31, 2021

Scaling up the clinical trial manufacturing facility at Royalmount

The NRC's Human Health Therapeutics Research Centre is also working to set up a GMP platform at its existing Royalmount Avenue biomanufacturing facility in Montréal to develop and scale up COVID‑19 vaccine candidates for clinical trials in Canada.

Our clinical trial manufacturing facility, managed by the Human Health Therapeutics Research Centre, is used to develop and scale up processes to produce biological medicines. As part of its development capacity, the facility is equipped with pilot-scale bioreactors (200 L and 500 L), which will be operationally available to produce up to 100,000 doses of vaccine per month once one is available.

A $15 million investment has been provided by the Government of Canada for upgrades to the facility for Good Manufacturing Practice (GMP) compliance, which will enable the NRC to produce vaccines for clinical trials in Canada. A further $29 million will support the second phase of critical operations to maintain the facility, as well as new equipment and infrastructure to fill and finish individual doses of vaccine.

The work to refine and certify quality systems at the facility will include:

• bringing the existing facility up to GMP-compliant regulatory standards
• installing equipment to expand capacity
• managing information

Once the facility is GMP-compliant, it will be able to accelerate the scale-up production and testing of various types of vaccine candidates in the context of the current COVID‑19 outbreak, including protein-based, viral vector-based, and antibody-based products.