Biologics and Biomanufacturing program

We are seeking collaborators to:

• Develop a pipeline of monoclonal antibodies, bi- and multi-specific antibodies, single-domain antibodies, antibody-drug conjugates and non-antibody protein therapeutics;
• Develop advanced algorithms for identification of targets and biomarkers, as well as companion diagnostic biomarker data sets to enable patient stratification and personalized medicine; and
• Develop, scale-up and transfer bioprocesses including microbial, mammalian, and viral vector expression systems that are compatible with current Good Manufacturing Practices (cGMP).

We offer unparalleled expertise and leading-edge facilities at three stages of development:

• Candidate design, selection, and optimization: NRC's streamlined Antibody Generation and Prioritization expertise, which yields both traditional and single domain antibodies, together with our bioinformatics and protein design approaches and high-throughput assays for ranking antibody functionality and manufacturability, allow our clients to select or improve therapeutic antibody candidates rapidly. We also offer non‑antibody protein expertise.
• Bioprocess development: In response to the demand for increased productivity of industrial bioprocesses, NRC has focused on Biomanufacturing to generate more robust, rapid and less costly production processes. Over the past two decades, our unique Microbial Fermentation Pilot Plant and Cell Culture Pilot Plant have successfully delivered improved bioprocesses to a long list of satisfied clients.
• Preclinical development: Evaluation of new candidates through translational science is essential for demonstrating product safety and efficacy. Through our Functional Characterization and Analytics expertise, and our Preclinical in vivo Facility, NRC's proprietary assays and test models are providing critical data about biologic candidates to collaborators as they prepare their Investigational New Drug applications.

NRC serves as an integrated R&D extension to your team. We can de-risk product development, add significant value to biologic candidates, and accelerate their progress through every step of the value chain, up to early clinical trials.

Our business specialists have established best practices to guide the management and commercialization of intellectual property for co-developed products and enabling technologies.

We observe the rigorous standards set forth by Health Canada's Biologics and Genetic Therapies Directorate (BGTD), ensuring that all our co-developed products meet their regulatory approval requirements to be sold in Canada and other jurisdictions. Canadian cGMP biologics manufacturers who benefit from our bioprocessing expertise will be well positioned to supply both domestic and global markets.