by Jovian Tsang
The multi-door, air-locked entrances, background hum of machinery and frequent sightings of personnel in full-body biosafety suits could easily lead one to believe that world-ending biohazardous material were secretly being stored in the halls of The Ottawa Hospital.
In actuality, this facility is where human-grade oncolytic viruses, or OVs, are being manufactured—one of only a few facilities worldwide with the ability to produce these specialized viruses for clinical trials. Its vials contain pure and highly concentrated OVs that will eventually be administered to human patients in early-phase clinical trials in Canada, the United States and Europe.
The Ottawa Virus Manufacturing Facility (OVMF) has a team of more than 20 highly qualified personnel with over 50 years of collective experience in process development and Good Manufacturing Practices (GMP). The centre is able to perform full Grade B GMP-compliant manufacturing as well as several biochemical, potency, and assay development through the Good Laboratory Practices (GLP) research labs. In addition, the facility also provides process development expertise to manufacturing processes. The OVMF has produced viruses for both phase I and II clinical trials.
And with the approval of the first OV therapy in the U.S. late last year, activity in this area of cancer biotherapeutics is heating up.
The facility has a full slate and a steady stream of potential clients knocking on their door. Current clients include investigators looking to begin clinical testing, as well as small-to-medium biotechnology companies and large pharmaceutical companies.
“With each manufacturing run, there is potential to treat several hundred people, depending on therapeutic dose,” says Dr. Megan Mahoney, OVMF’s Operations Manager.
But it’s not just a matter of manufacturing. To turn a promising viral vector into human-grade clinical product approved by regulators can take more than two years. Why so long? Process development and assay development. It doesn’t sound daunting, but these terms include a slew of procedures that need to be developed, optimized, validated and documented to the satisfaction of health regulators.
Canada has a growing list of certified GMP and Good Laboratory Practices (GLP) facilities contributing to the acceleration and development of the most promising cancer biotherapeutics and BioCanRx is playing role in supporting their leading-edge technologies and expertise. And by supporting facilities like the OVMF, BioCanRx is ensuring that these much-desired facilities remain available to its network of researchers.
Learn more about BioCanRx’s Core Facilities at our website.