Education and Professional Standing
- PhD, Molecular & Medical Genetics, University of Toronto, 2000
- Postdoctoral Training: Gene Therapy Program, University of Pennsylvania, 2000-2004
Adenoviruses are prevalent in the human population, and normally cause mild upper respiratory infections or the common cold. Using molecular biology approaches, these viruses have been modified and can now be used as delivery vehicles for therapeutic or antigenic genes. Adenoviral vectors are capable of infecting a wide range of target cells and have been used extensively for the preparation of genetic vaccines. Pre-clinical studies in animals have already identified several promising vaccine candidates.
In order to conduct clinical trials in human patients, adenoviral vectors must be manufactured according to strict guidelines to ensure their safety, purity and potency. These guidelines, as enforced by Health Canada and other regulatory agencies in the world, are called Good Manufacturing Practices (GMP). McMaster University has established the Robert E. Fitzhenry Vector Laboratory as the first Canadian laboratory that will produce clinical-grade adenoviral vectors under GMP. The 3000-square foot manufacturing facility, located at the Michael G. DeGroote Centre for Learning and Discovery, includes five separate cell culture rooms, each containing a Class 100 biosafety cabinet. Two cleanrooms are outfitted with bioBubble® softwall technology with supply air delivered via ducts to terminal HEPA filters. One cleanroom is dedicated to processing and purification of vectors, and the other for aseptic filling. This facility serves the immediate needs of researchers in McMaster University and other institutions to expedite the transition of promising bench research to bedside treatment, and at the same time minimizes the cost associated with production of high quality, clinical-grade vectors.
The Vector Laboratory was most recently involved in the production of a clinical-grade AdAg85A vector, an Adenovirus vector that will be used in a phase I clinical trial as a tuberculosis vaccine. The AdAg85A vector has passed all required safety tests by Health Canada and the trial will commence summer 2009.