Thank you, Mr. Chair, for the invitation to speak with you today about the National Research Council of Canada, as part of your study on domestic manufacturing capacity for COVID-19 vaccines.
I'd like to begin by acknowledging that the National Research Council facilities are on the traditional unceded territories of many first nations, Inuit and Métis people, and their ancestral footsteps and rights extend beyond the boundaries that exist today. We respectfully honour these peoples' rights, history and relationships with this land.
My name is Maria Aubrey, and I'm the vice-president of strategic initiatives and responsible for the design, build and operationalization of the NRC's new biologics manufacturing centre.
I am joined today by my colleague from the NRC, Dr. Lakshmi Krishnan, vice-president of life sciences. In this capacity, she oversees the human health therapeutics, aquatic and crop resource development and medical devices research centres.
The NRC is Canada's largest federal research and development organization. Throughout the COVID-19 pandemic, the NRC has been an important contributor to Canada's response, including testing PPE and helping develop a made-in-Canada solution for COVID-19 testing.
The NRC also provided support to firms through the new “challenge” programs and our industrial research assistance program, best known as IRAP. Today, IRAP has invested $81 million to support 14 small and medium-sized enterprises developing made-in-Canada vaccines and therapeutics. Through IRAP, the NRC also supported more than 2,200 innovative businesses, helping them weather the pandemic and preserving over 26,000 jobs in Canada.
Early in the pandemic, the Government of Canada asked the NRC to establish the new biologics manufacturing centre for biomanufacturing production at our Royalmount campus in Montreal, Quebec. In June of 2021, we completed the construction of the centre. This new end-to-end biomanufacturing facility is designed to produce cell-based vaccines and other biologics in compliance with good manufacturing practices, GMP. This includes viral vector, protein subunit, virus-like particles and other recombinant proteins.
The biologics manufacturing centre has a production capacity of approximately 4,000 litres, which could translate into approximately two million doses of a vaccine per month. It is important to note, however, that the number of doses will vary widely depending on the specific vaccine and the manufacturing yield.
The biologics manufacturing centre was built to fulfill a public good mandate. This means if another pandemic or health emergency strikes, the biologics manufacturing centre will be made available to produce cell-based vaccines or other drugs to keep Canadians healthy and safe. In non-pandemic emergency times, it will focus on public interest projects such as the production of drugs for rare diseases to support the health of Canadians and protect those at high risk. Collaborating with industry and academic partners, the biologics manufacturing centre will complement and support Canada's domestic capacity and knowledge in biomanufacturing.
In June 2021, through the budget implementation act, the NRC received royal assent for the legislative authority to engage in the production, on any scale, of drugs and devices, as those terms are defined in section 2 of the Food and Drugs Act, for the purpose of protecting or improving public health in Canada or elsewhere. This new authority allows the NRC to produce vaccines and other biologics at the BMC on a commercial scale, once all Health Canada approvals have been secured.
The NRC is now completing the commissioning, qualification and validation process of the centre to demonstrate GMP compliance. This is required for all new biomanufacturing facilities producing drugs for humans in Canada.
In February of 2021, the Government of Canada signed a memorandum of understanding with Novavax 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 of 2022, Health Canada announced the authorization of the Novavax COVID-19 vaccine in adults 18 years of age and older.
The NRC is working with Novavax on the technology transfer. It includes pilots from small to large scale to demonstrate the required quality characteristics through engineering runs and quality production batches. Once that is satisfactorily achieved and Novavax receives approval for production at the centre, production can continue on a commercial scale.
To conclude, as an important part of Canada’s broader biomanufacturing and life sciences strategy, the new biologics manufacturing centre will help increase domestic capacity for vaccine innovation and production to bolster Canada’s resilience and preparedness. The biologics manufacturing centre is intended to serve as a foundational element for a proposed broader system of federal capabilities and assets to respond to future pandemics or other health priorities, supporting Canada’s national biomanufacturing security and sovereignty.
Thank you for your time, and we’d be pleased to answer your questions.