Boosting leadership in vaccine development
As the leading cause of birth defects, cytomegalovirus (CMV) affects more children than Fetal Alcohol Syndrome or Down Syndrome and infects up to 90 percent of adults worldwide. Typically unnoticed in healthy people, CMV can be life-threatening for the immunocompromised, which includes persons infected with HIV, organ transplant recipients and most commonly, newborn infants.
While there is currently no vaccine for CMV, a potential breakthrough solution developed by VBI Vaccines Inc. (VBI) at their Ottawa research facility is focused on the goal of safely and effectively preventing the transmission of the virus from mother to child. VBI’s innovative vaccine candidate is made of enveloped virus-like particles (eVLPs), which mimic the shape and structure of real viruses without containing any potentially infectious viral material.
Starting out as a small enterprise with just three people, VBI connected with the National Research Council (NRC) for access to the infrastructure and scientific expertise that would prove critical to moving their innovations forward. In doing so, VBI and NRC have since established a high-yield production system that has allowed VBI to manufacture enough vaccine material for clinical testing.
Meeting supply and demand
Having established a proof of concept for its eVLP-based vaccine in 2011, VBI knew that it would need to respond quickly to the inevitable changes that would occur during the research and development process. "The biotechnology business is one that demands quick decision-making because things can change without notice," says Adam Buckley, VBI's Vice-president of Business Development. "Being able to use NRC's labs and resources as extensions of our own allowed us to quickly respond to our scientific data despite our size."
As an essential component to shortening the time to market of a potential vaccine candidate, determining the best production system and conditions that would result in the highest yield of eVLPs became a top priority. The close working relationship between VBI and NRC also allowed for seamless definition of the purification parameters needed to properly prepare the material for preclinical studies.
"Our close collaboration with VBI allowed us to realize significant accomplishments over a short period of time," says Parminder Chahal, Project Leader and Research Officer, Viral Vectors Team with NRC. As a result, following successful preclinical testing at NRC’s facilities, VBI was able to scale-up their vaccine production to the quantities needed.
Prevention on a worldwide scale
With a vaccine candidate that is designed to be compliant with both U.S. and Canadian health regulatory requirements and that meets Good Manufacturing Practices (GMPs), VBI believes it is now poised to produce vaccine material suitable for human clinical trials. Buckley fully expects to continue VBI's strong partnership with NRC, noting that the goals of both groups are closely linked. "NRC understands what we are trying to do and demonstrated remarkable agility in adapting to our needs," he says.
In addition to its financial support for the development of the CMV vaccine candidate itself, NRC's Industrial Research Assistance Program (IRAP) is also working with VBI to develop its Lipid Particle Vaccine (LPV™) formulation technology which helps stabilize and preserve vaccines during shipment and storage. The new "thermostable" technology helps ensure that vaccines will remain safe and fully potent even if exposed to temperatures up to 40°C.
"Being able to meet the global demand for the CMV vaccine, which is predicted to reach 7.6M doses by 2030, will have a profound impact on the health of both mothers and babies," says Buckley. He and his team, which has grown to a staff of twenty, now envision a day where VBI can inject hope for families all over the world and provide a much-needed solution in preventing the transmission of cytomegalovirus.