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主管部门进行了大量投资，以建立能力并实施应对流感大流行的防范计划。在流感大流行期间，**国家对本国人口的疫苗需求增加，迅速提供匹配疫苗至关重要。然而，目前以鸡蛋为基础的生产工艺可能很难满足预期的疫苗需求，例如在可能破坏鸡蛋供应链的禽流感大流行毒株的情况下。因此，根据国家和国际卫生当局的建议，已开发并验证了替代生产工艺，包括使用重组技术的细胞培养和基于植物的生产平台，以开发替代技术和补充技术，以便在紧急情况下快速有效地作出反应。**目前在加拿大，流感疫苗的生产仅由一家制造商**使用基于鸡蛋的生产技术进行。虽然Medicago目前正在开发基于植物的工艺和生产能力，以应对潜在的流感大流行和其他新出现的传染病，但对于加拿大来说，投资于细胞培养生产的病毒疫苗能力具有高度的战略意义，就像美国的情况一样。利用申请人实验室最近开发的先进技术和Pnuvax公司已经运行的细胞培养生产能力，我们的目标是通过解决所有工艺步骤的局限性，加速和加强大流行性流感疫苗的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 of**Health and other national and international authorities to build capacities and implement**preparedness plans to face influenza pandemic situations. During influenza pandemic,**countries have increased vaccine demand for their own population and it is critical to have**rapid availability of matched vaccines. However, it may be highly problematic to meet the**expected vaccine demand with current egg-based manufacturing process, for instance in the**case of an avian pandemic strain that could potentially disrupt the supply chain of eggs.**Therefore, alternative production processes, including cell culture and plant-based production**platforms using recombinant technology, have been developed and validated following**recommendations from National and International Health authorities to develop alternative**and complementary technologies for rapid and effective responses in emergency situations.**Currently in Canada, influenza vaccine production is carried out by only one manufacturer**using egg-based production technology. Although plant-based process and production**capacities are currently being developed by Medicago, for a solid and sustain preparedness**plan to face influenza potential pandemics and other emerging infectious disease, it is highly**strategic for Canada to invest in cell culture produced viral vaccine capacities as it is the case**in the US. Taking advantages of advanced technologies recently developed in the applicants**laboratories and cell-culture production capacities already operational at Pnuvax Inc., we aim**to accelerate and intensify, by addressing the limitations at all process steps, the**development and validation of a cell-culture production platform for pandemic influenza**vaccines as a national alternative and complementary vaccines source.