Expanding Canada's biomanufacturing capacity: 2022–⁠2023 annual report

Plain HTML version: Laying the foundations for tomorrow's innovations: 2022–2023 annual report

We are supporting the Government of Canada's commitment to increasing domestic biomanufacturing capacity along the entire production continuum: from research and development to the production of material for clinical trials.

Homegrown vaccines and other biologics

Helene Mauboussin, Quality Assurance Team Lead, Human Health Therapeutics Research Centre

Short video of Helene Mauboussin posing in front of pharmaceutical manufacturing machinery in a clinical trial biological drug manufacturing facility.

Helene Mauboussin, Quality Assurance Team Lead, Human Health Therapeutics Research Centre

Short video of Helene Mauboussin posing in front of pharmaceutical manufacturing machinery in a clinical trial biological drug manufacturing facility.

The biomanufacturing research and development laboratories of the NRC's Human Health Therapeutics (HHT) Research Centre play a vital role in scaling up the manufacturing process, enabling vaccines and other biologics-based therapeutics to advance from research to clinical trials. Helene Mauboussin leads HHT's Quality Assurance team, which ensures all elements of the complex production process meet precise quality requirements every step of the way.

"My team reviews and approves all procedures and documentation related to the production that happens in our facilities. We investigate and correct every deviation, so we can be confident in the safety, identity, strength, purity and quality of every product, every time. This is required to meet regulations and, more importantly, to keep people safe.

Although the NRC has been working in vaccine research and development for decades, the past few years have been really exciting for us, given the increased global interest in biomanufacturing. Most notable this year was the substantial completion of the clinical trial material facility, which is just down the hall from the R&D labs. My team is currently working on the commissioning, qualification and validation process for the new facility, and we hope to be able to produce our first product in the facility in 2024. With the new facility, the goal is to enable drugs researched and developed in Canada to move through clinical trials here as well.

We're also looking forward to some critical upgrades in our R&D labs, which will bring us more in line with the new facility. In addition to modernizing our space, the new funding will also allow us to update much of our equipment so it matches what's in the clinical trial material facility. This alignment will make the technology transfer from the R&D lab to the clinical trial material facility much faster and easier."

"Our work ensures we can be confident in the safety, identity, strength, purity and quality of every product, every time."

Contributing to the Canadian biomanufacturing continuum

In 2020, we were tasked, on behalf of the Government of Canada, to create something unique in Canada: a biomanufacturing facility intended specifically to undertake full-scale production in support of a public good mandate. In August 2022, the Biologics Manufacturing Centre received its drug establishment licence, granting it formal authorization for production of drugs for use in Canada. In parallel, we were setting in motion the process of transferring the governance and operations of the Biologics Manufacturing Centre to a not-for-profit corporation.

This was done to enable the facility to function independently of the government, as a contract manufacturing organization, while continuing to deliver on its mandate to respond to pandemic and other health emergency preparedness needs, support public-interest projects, and contribute to the growth and resilience of Canada's life sciences sector. CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, was selected as co-founder of this new not-for-profit, which was incorporated in December 2022. On April 1, 2023, Biologics Manufacturing Centre (BMC) Inc. officially assumed responsibility for the operations of the Biologics Manufacturing Centre.

With the upgrades to the HHT research and development labs, the construction of the clinical trial material facility and the completion of the Biologics Manufacturing Centre, the biomanufacturing triad—R&D process development, clinical lot production and full-scale manufacturing—will all soon be available at the NRC's Royalmount site. The 3 biomanufacturing facilities can be used separately or collectively to support public good projects or individual client needs. By existing side-by-side on a single campus, they are working together to support Canada's Biomanufacturing and Life Sciences Strategy goal of building a robust, end-to-end continuum of public-enabling biomanufacturing capacity in Canada.

Accelerating the journey from discovery to therapy

In early 2022, we partnered with Concordia University and Kyoto University's Center for iPS Cell Research and Application (CiRA) to accelerate research on the therapeutic use of iPS (induced pluripotent stem) cells. iPS cells are stem cells produced from adult skin cells and can be used to produce any type of cell in the body, making them highly promising for treating cancer, heart disease and other hard-to-treat conditions—without the usual risk of rejection. Bridging the gap between scientific breakthrough and practical application often takes years, but the NRC-Concordia-CiRA team, under the Cell and Gene Therapy Challenge program, has already started developing the tools needed to bring this ground-breaking cell therapy to the mainstream.

Hyper-precise calibration for new radiation therapies

Advances in cancer treatment have the potential to offer improved outcomes with fewer side effects.

Correct dosage is required to deliver these therapies safely and effectively, but that depends on the ability to precisely measure new modalities of radiation treatment.

Teams at the Metrology Research Centre are working with proton therapy, synchrotron X-ray beams and ultra-high dose radiation therapy to ensure these therapies can be measured and calibrated to deliver maximum benefit and improve cancer outcomes.

Early pandemic warning through wastewater monitoring

The NRC Industrial Research Assistance Program (NRC IRAP) provided funding for a 2022 pilot project with the Greater Toronto Airports Authority looking at how inbound wastewater monitoring could help detect strains of COVID-19 and other infectious diseases sooner and less invasively than through individual testing.

The pilot project showed promise, and NRC IRAP is now in discussions about broader deployment of the technology to provide earlier warning and improve future pandemic response efforts.

Better control for centrifugal microfluidic testing

In 2023, a team in the Medical Devices Research Centre received a Canadian patent for its incorporation of pneumatic control into centrifugal microfluidic chips.

These chips can be used to automate several steps in biological testing by circulating various liquid buffers and reagents through specially designed miniature channels. The pneumatic technique helps fluids move as intended through the chips during testing, ensuring assays can be executed fully.

In addition to the Canadian patent, this technology has also received patent protection in Australia, Europe, Japan, South Korea and the United States.

A step toward treatment for Alzheimer's disease

Working with researchers at the University of Alberta, scientists in the Nanotechnology Research Centre have discovered a type of biodegradable nanoparticle that may disrupt the accumulation of a protein associated with some of the degenerative effects of Alzheimer's disease.

While the exact role of these proteins in the development of Alzheimer's disease still needs to be more fully understood before a therapy can be developed, this discovery marks an exciting step toward a treatment that could stop or even reverse the disease.

Atypical fermentation for non-human health products

In early 2022, we opened a new atypical fermentation facility on Prince Edward Island, where members of our Aquatic and Crop Resource Development Research Centre work on the sustainable transformation of Canadian bio-based resources into higher-value products.

This new facility offers customized fermentation research for personal care, specialty products, and food and feed applications.

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