Biosafety Level 2 at ITR
In recent years, cell and gene therapies have been gaining grounds as therapies of the future, with applications ranging from oncology and rare genetic disorders to infectious disease vaccines and immunotherapies. These modalities often involve viral vectors (AAV, lentivirus, adenovirus), bacterial vectors, live viruses, plasmid DNA, and oligonucleotides, all requiring specialized handling under Biosafety Level 2 (BSL‑2) conditions.
Extended Vivarium Capabilities
At ITR, our new BSL‑2 vivarium supports a broad spectrum of toxicology and efficacy studies. Rodents are housed in individually ventilated cage systems (IVCs), which provide controlled airflow, reduce cross‑contamination, and enhance animal welfare by maintaining a stable micro‑environment. All animal handling and dosing procedures are performed inside biosafety cabinets, ensuring operator protection and containment of therapeutic agents. Importantly, our vivarium accommodates immunocompromised animal models such as NSG mice and humanized models, which are essential for evaluating therapies that rely on human cell engraftment or immune modulation. This enables us to generate translational data for a wide range of therapeutic area, including:
- Oncology: Oncolytic viruses, CAR-T and TCR therapies, tumor-targeted gene therapies.
- Infectious diseases: Viral vaccines, antiviral agents, bacterial vector-based therapies.
- Genetic disorders: AAV or lentiviral gene replacement therapies, RNA-based therapeutics.
- Immunology: Oligonucleotide drugs, immune modulators, and biologics requiring immunocompromised models.
An Integrated BLS-2 Laboratory Network
To ensure BSL-2 compliance across the entire workflow, all supporting laboratories including clinical pathology, pharmacokinetic (PK), immunology and necropsy have been upgraded to BSL‑2 standards. This integrated BSL-2 laboratory network ensures biosafety from dosing through to sample analysis, enabling seamless study conduct under regulatory expectations.
Licensed by the Public Health Agency of Canada
As of September 2025, ITR is extremely proud to announce that Canada’s Public Health Agency has officially recertified our vivarium and laboratories BSL-2 compliant following rigorous inspections of our standard operating procedures, staff training, monitoring program and facility infrastructure. With this licence, our teams are fully prepared to meet the challenges posed by cell and gene therapy development, vaccine innovation and advanced immunotherapies, offering sponsors a trusted partner for both safety and efficacy evaluations.
