Virus Manufacturing

BMC’s Virus Manufacturing Facility (previously known as the Ottawa Virus Manufacturing Facility) specializes in the production of Biosafety Level 2 (BSL-2) viruses for human clinical Phase I/II trials. Together, our highly qualified team has over 90 years of collective experience in Process Development and GMP manufacturing. We have successfully undergone GMP audits to FDA and European standards and have manufactured several oncolytic rhabdoviruses and poxviruses for clinical trials currently ongoing or completed in Canada, the United States and Europe.

BMC also provides a full range of activities associated with development and manufacture of novel Biotherapeutics including: assay development and qualification, process development, GLP analytical samples testing, and GMP manufacturing. The BMC manufactured clinical-grade virus products used in clinical trials in Canada, the United States, Europe and Asia, and will have undergone cGMP audits to FDA and European standards for commercialization purposes.

BMC currently holds contracts with several academics and biotechnology companies and shares the goal of bringing their oncolytic viruses to clinical trial and ultimately providing innovative solution for cancer treatment. BMC has manufactured products that have the potential to treat thousands of individuals across several cancer types. BMC is steadily growing, with increased offerings including stability testing programs.

Viral GMP facility

BMC has a validated Grade B GMP-compliant virus manufacturing facility specifically designed to manufacture BSL-2 pathogens. The facility has both gowning and de-gowning airlocks for proper personnel flow and validated cleaning procedures to maintain compliance with ISO 5 standards. The 37 m2 GMP facility houses a RollerCell 40 (RC40) incubator permitting the simultaneous production from 40 extended roller bottles with a combined cell growth surface area of 170,000 cm2.

Process development and assay development suites

To facilitate the continuous improvement of our manufacturing process, we have a dedicated Process Development (PD) suite that contains all equipment necessary to undertake full-scale or scaled-down engineering runs.

Complimentary to our GMP manufacturing core, our facility also houses a dedicated and access controlled QC/GLP testing lab. Here, we perform biochemical, potency, and identity assays that are qualified for release and characterization testing of process development samples, clinical drug products, and clinical samples.

All assay development, SOP development, execution, and validation are in accordance with ICH Q2 guidelines as appropriate for early phase clinical trials, ensuring quality results for analytical procedures. Execution of all validated assays involves controlled, reference standard banks used in parallel with assay samples. All equipment is qualified for use (IQ/OQ or PQ) and calibrated. All critical equipment, including fridges, freezers, and incubators are monitored 24/7.