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

在过去的几十年里，美国卫生部和其他国家和国际当局已经进行了大量投资，以建立应对流感大流行的能力和实施准备计划。在流感大流行期间，各国对其本国人口的疫苗需求增加，因此迅速获得匹配疫苗至关重要。然而，目前基于鸡蛋的生产工艺在满足预期的疫苗需求方面可能存在很大问题，例如在可能破坏鸡蛋供应链的禽流感病毒株的情况下。因此，替代生产工艺，包括细胞培养和使用重组技术的基于植物的生产平台，根据国家和国际卫生当局的建议，开发了替代和补充技术，以快速有效地应对紧急情况，目前，在加拿大，流感疫苗的生产仅由一家公司进行，该公司使用基于鸡蛋的生产技术。虽然Medicago目前正在开发基于植物的工艺和生产能力，但为了制定一个坚实和可持续的预防计划，以应对潜在的流感大流行和其他新出现的传染病，加拿大投资于细胞培养生产病毒疫苗的能力是高度战略性的，因为它是美国的酪蛋白。利用Pnuvax公司最近在应用实验室和细胞培养生产能力中开发的先进技术，我们的目标是通过解决所有工艺步骤的局限性，加快和加强大流行性流感疫苗细胞培养生产平台的开发和验证，作为国家替代和补充疫苗来源。

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.