Biomanufacturing

Biomanufacturing is a manufacturing process that uses living cells to produce commercial products. A wide variety of everyday items are produced using biomanufacturing, including some types of fuel, cosmetics and even diapers.

In a human health context, we use biomanufacturing to produce vaccines and therapeutics, which are collectively called biologics. Biotechnology is the technology used in biomanufacturing.

Before biologics can be commercially produced for sale in pharmacies or to be administered in hospitals, rigorous testing is required at various levels during the production process. This is necessary to ensure that every single dose administered to people is safe and will do exactly what it is expected to do, every single time.

It is much easier, and less expensive, to start testing the production process on small quantities of biologics. So, the biomanufacturing process is first tested, analyzed, tweaked and perfected at a small scale to produce small amounts of the intended product. The process is then recreated at successively larger scales, a practice called scaling up.

Researchers at the Human Health Therapeutics Research Centre play a vital role in designing, testing and scaling up the biomanufacturing process so that vaccines and other biologics can advance from research to clinical trials in Canada.

Our biomanufacturing expertise

Cell lines: Biologics use cells to produce an antigen, which triggers a body's immune response. Our researchers have developed multiple mammalian cell lines that are used to manufacture vaccines and other therapeutics. Our research teams can also express proteins and other biologics in microbial cell systems.

Cell production: The antigen-producing cells are grown in bioreactors, which provide optimal growing conditions. Growing the cells and producing the antigen is called upstream processing.

Scale up: The mixture inside the bioreactors is called a cell culture. The cell culture must be scaled up to larger volumes by transferring it from small-scale vessels to successively larger bioreactors.

Separation, purification and characterization: When an adequate amount of an antigen is produced, the cell culture is separated to remove impurities and other substances, which are required during cell growth but aren't part of the final biologics. The process of separating the cell culture and purifying the vaccine is called downstream processing.

Technology transfer: Technology transfer is the process of learning step-by-step how to make specific biologics at each scale. It includes identifying the product-specific materials and equipment and is a unique process for each product in each facility.

Clinical trial material: The clinical trial material facility has the capacity to replicate drug production processes that follow good manufacturing practices at a smaller scale. The facility can be used to validate the production process or to produce the quantity of materials required to conduct human clinical trials.