Acceleration and Intensification of Cell Culture-Produced Influenza Vaccines for Rapid Response to Pandemic Situation

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Over the last decades, significant investments have been directed by the US Department ofHealth and other national and international authorities to build capacities and implementpreparedness plans to face influenza pandemic situations. During influenza pandemic,countries have increased vaccine demand for their own population and it is critical to haverapid availability of matched vaccines. However, it may be highly problematic to meet theexpected vaccine demand with current egg-based manufacturing process, for instance in thecase of an avian pandemic strain that could potentially disrupt the supply chain of eggs.Therefore, alternative production processes, including cell culture and plant-based productionplatforms using recombinant technology, have been developed and validated followingrecommendations from National and International Health authorities to develop alternativeand complementary technologies for rapid and effective responses in emergency situations.Currently in Canada, influenza vaccine production is carried out by only one manufacturerusing egg-based production technology. Although plant-based process and productioncapacities are currently being developed by Medicago, for a solid and sustain preparednessplan to face influenza potential pandemics and other emerging infectious disease, it is highlystrategic for Canada to invest in cell culture produced viral vaccine capacities as it is the casein the US. Taking advantages of advanced technologies recently developed in the applicantslaboratories and cell-culture production capacities already operational at Pnuvax Inc., we aimto accelerate and intensify, by addressing the limitations at all process steps, thedevelopment and validation of a cell-culture production platform for pandemic influenzavaccines as a national alternative and complementary vaccines source.