The COVID-19 pandemic has highlighted the need for versatile facilities in Canada, not dedicated to a single product, to be prepared for future health crises. Since December 2020, over 97 million doses have been administered to the country’s population, an unprecedented achievement in Canadian history.

Biomanufacturing is defined as the set of processes for manufacturing complex molecules in the biopharmaceutical domain using biological processes involving cells or other living organisms. These molecules can include proteins (enzymes, antibodies), peptides, viruses, cell therapies, blood product fractions, and nucleotide chains such as RNA or DNA. Biomanufacturing products encompass vaccines, several biopharmaceuticals used to treat autoimmune diseases (rheumatoid arthritis, etc.), cancer treatments, and therapies for rare diseases.

In Canada in 2021, 131 companies manufacturing pharmaceutical products and drugs were present, employing 11,830 people.

Biomanufacturing in Quebec

Quebec has a dynamic ecosystem in the life sciences and health technologies (LSHT) sector, offering significant advantages to attract foreign biomanufacturing companies. In 2022, Moderna announced the construction of its messenger RNA (mRNA) plant in Laval, Quebec. The realization of a project of this nature is made possible through close collaboration among various stakeholders in the Quebec LSHT ecosystem, including the Ministry of Economy, Innovation and Energy, Montreal International, and Investissement Québec International. Representatives from these organizations, along with Montreal InVivo and Moderna Canada, discuss their roles and Quebec’s strengths in the video capsules below.

GSK (GlaxoSmithKline): The vaccine production site in Sainte-Foy plays a crucial role in manufacturing a significant portion of Canada’s seasonal flu vaccines and supplies the national pandemic flu vaccines.

Moderna: The Laval facility is expected to produce up to 100 million doses of its original COVID-19 vaccine per year, with the capacity for 200 million booster doses. Once operational in 2024, it will provide access to locally manufactured mRNA vaccines for various respiratory viruses, including COVID-19, seasonal flu, respiratory syncytial virus (RSV), and other potential viruses.

Biologics Manufacturing Centre (BMC) : This biomanufacturing facility located in Montreal contributes to the growth of the national production capacity in biomanufacturing. It ensures secure manufacturing of vaccines and other biological products in Canada, playing an essential role in the Canadian bioproduction infrastructure and contributing to the government of Canada’s Strategy on Biomanufacturing and Life Sciences.

Immune Biosolutions: This clinical-stage biotechnology company, based in Sherbrooke, specializes in avian and human antibodies. Its drug, IBIO123, has successfully passed the first two phases of clinical trials. It is an inhalation immunotherapy, providing an innovative approach to combat COVID-19.

Biodextris: Located in Laval, this company offers efficient manufacturing capacity for high-quality proteins and biomolecules in the health industry, operating in both cGMP (Current Good Manufacturing Practice) and non-GMP environments. Their expertise covers the production of proteins at various scales, ranging from milligrams to tens of grams per batch, in diverse applications such as human health and monoclonal antibodies.

KABS: Situated in Saint-Hubert, KABS provides integrated teams for drug development, offering advanced technical support and competitive solutions in terms of speed and cost. The site complies with regulatory standards from Health Canada, the US FDA, European QPs, Brazil’s ANVISA, the World Health Organization (WHO), as well as customer auditors from over 18 countries. KABS specializes in the production of new drugs, generic drugs, and biopolymers.

Quebec possesses a highly qualified talent pool in the field of Life Sciences and Health Technologies (LSHT). With the presence of several general and professional education colleges (cégeps) and universities offering life sciences programs, the region has a reservoir of talent ready to contribute to the development of the biomanufacturing industry.

Montreal InVivo has created a map of collegiate and university-level life sciences programs available in Quebec. MAP

A study was conducted on biomanufacturing training programs with the aim of assessing their alignment with the needs of businesses. The objective was to measure the correspondence between skills acquired in these training programs and those sought by businesses. The analysis focused on programs in cégeps (DEC and AEC programs), university programs (undergraduate and graduate), as well as programs offered by private institutes and non-profit organizations (NPOs) specializing in biomanufacturing. The results obtained have shown that the various required skills are covered in various courses offered, but they are scattered across different programs. Additionally, there is a lack of practical training, especially concerning sterile environments. STUDY

Two DEC programs play a central role in training future technologists, technicians, and operators in biomanufacturing in Quebec, notably those offered at cégep Gérald Godin and Collège John Abbott.

McGill University and Polytechnique Montréal offer training in bioengineering and bioprocesses with concentrations in biomanufacturing. The University of Sherbrooke offers training in biotechnological engineering, while the University of Montreal provides training in drug development. PrEEmiuM, a collaborative program involving six organizations (INRS, McGill University, Laval University, University of Waterloo, University of Montreal, and Polytechnique Montréal), aims to train engineers and scientists in (bio)pharmaceutical engineering at the bachelor’s, master’s, and doctoral levels.

Pharmabio Développement, the workforce sector committee for the pharmaceutical and biotechnological products industries, offers a course in Good Manufacturing Practices (GMP) and validation techniques.

There are two main organizations that provide specialized biomanufacturing training in Quebec and elsewhere in Canada, CASTL and CATTI. Canadian Alliance for Science and Technology in the Life Sciences (CASTL), adMare Academy Partner, offers biomanufacturing training (production of monoclonal antibodies and other biotherapies) and has training centers in Charlottetown and Montreal. CASTL has signed an exclusive agreement for the Canadian distribution of training from the National Institute for Bioprocessing Research and Training (NIBRT) based in Ireland. CATTI offers training, both online and in-person, in cell and gene therapies, GMP, and quality systems at their training center in Guelph, Ontario.

In response to the lack of manufacturing capacity in Canada, the Canada’s Biomanufacturing and Life Sciences Strategy was implemented in 2021. Strategic investments have already yielded tangible results, strengthening vaccine platforms and production processes. These investments encompass the development and production of RNA vaccines, protein-based vaccines, improvement of viral vector manufacturing capacity, as well as the acquisition of new filling and finishing capabilities. Since 2020, over 500 million dollars have been invested in 13 Quebec-based biomanufacturing projects.

Biomanufacturing is defined as a future focus in the Quebec Life Sciences Strategy for 2022-2025. Industrial biomanufacturing projects demand highly specialized industrial skills, particularly in the use of sophisticated equipment in a regulated context. To attract private investment projects, the availability of a highly skilled workforce is crucial. In this regard, the Quebec government has granted a subsidy of 2.5 million dollars to the CASTL to establish a Quebec-based training institute in biomanufacturing.

Montréal InVivo has produced a map of college and university training in life sciences available in Quebec.

Analysis of postsecondary training dealing with biomanufacturing in Quebec

The objective of this study is to establish the level of correspondence between the skills acquired in post-secondary training and those demanded by the biomanufacturing industry in the field of life sciences.

GSK (GlaxoSmithKline)

Global pharmaceutical company focused on innovation in vaccines and specialized medicines, aiming to maximize opportunities for treating and preventing diseases.

Biodextris

Biodextris develops, manufactures, and tests a wide range of biological products for vaccine, pharmaceutical, and other applications.

KABS

Laboratory offering a broad range of product development services to the biopharmaceutical industry, from initial discovery phase to global commercialization.

Immune Biosolutions

Biotechnology company specializing in the discovery and engineering of avian and human antibodies.

Moderna

Moderna leverages the unique properties of mRNA technology to develop innovative treatments aimed at improving the quality of life for patients.

Center of Excellence in Cellular Therapy (CETC) at C3i

Comprising a set of laboratories dedicated to manipulating human cells for therapeutic purposes, C3i is one of the international hubs for the development of cellular therapy and regenerative medicine.

Quebec is home to several world-renowned research centers that provide high-quality services to academic institutions and businesses. This expertise proves particularly valuable for companies specializing in biomanufacturing. Here are some examples:

The Early Drug Discovery Unit (EDDU) at McGill University’s The Neuro (Montreal Neurological Institute-Hospital)

Human health therapeutics research facility at the National Research Council (NRC)

The INRS Armand-Frappier Santé Biotechnologie Research Centre

Biopharmaceutics Platform and Continuous Flow Synthesis Laboratory at the University of Montreal

CERASP, college centers for the transfer of technology (CCTT) in Pharmaceutical Sciences and Related Industries.

The Eastern Canada Pandemic Preparedness Hub (ECaPPH): The ECaPPH represents a bio-innovation and biomanufacturing ecosystem, co-led by three Quebec universities (Université de Montréal, McGill University, and Université Laval). In collaboration with other major partners, whether academic, private, public, or non-profit, this environment aims to provide Canada with a resilient and agile response to future threats in pandemics and health.

Consortium Québécois Sur La Découverte Du Médicament (CQDM): CQDM is a non-profit biopharmaceutical research consortium with a mission to support and facilitate collaborative, multi-party R&D aimed at accelerating the translation or transformation of innovative technologies into solutions addressing unmet medical needs, while generating significant benefits for the Quebec and Canadian economy.

Médicament Québec: Médicament Québec is a coordinated approach to equip Quebec with innovative platforms for drug discovery, supply, and production, contributing to the revitalization of the pharmaceutical sector in Quebec. Initially motivated by the need to ensure local supply chain security, Médicament Québec brings together the strengths of academic universities, colleges, and companies in the generic and innovative drug sectors.

adMare BioInnovations: adMare BioInnovations leverages its technical and commercial expertise, specialized R&D infrastructure, and investment capital to develop strong life sciences companies, robust ecosystems, and talent ready to work in the Canadian industry.

Innovative Medicines Canada: Innovative Medicines Canada represents Canada’s innovative pharmaceutical industry.

In the Greater Montreal Area:

+470

billion dollars in investment for 12 biofabrication projects in Quebec by the Government of Canada, including 10 in the greater Montreal area.

2,5

million granted to CASTL by the Ministry of Economy, Innovation, and Energy for its establishment in Montreal.

3

CEGEPs offering training programs providing skills in biofabrication.

1

Biologics Manufacturing Centre (BMC)

Window on several impactful companies, researchers and organizations that support the ecosystem of biomanufactuing:

The researchers