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进行了大量投资，以建设能力并实施应对流感大流行情况的防备计划。在流感大流行期间，**各国增加了本国人口的疫苗需求，关键是**迅速获得匹配的疫苗。然而，用目前基于鸡蛋的制造工艺来满足预期的疫苗需求可能是非常有问题的，例如，在**禽流感大流行毒株可能扰乱鸡蛋供应链的情况下。**因此，根据国家和国际卫生当局的**建议，开发并验证了替代生产工艺，包括细胞培养和基于植物的生产**平台，以开发替代**和补充技术，以便在紧急情况下快速有效地反应。**目前在加拿大，流感疫苗生产只由一家制造商**使用基于鸡蛋的生产技术进行。尽管Medicago目前正在开发以植物为基础的工艺和生产**能力，以制定坚实和持续的准备**计划，以应对潜在的流感大流行和其他新出现的传染病，但对加拿大来说，投资于生产病毒疫苗的细胞培养能力是高度**战略的**，就像美国的情况**一样。利用申请者实验室最近开发的先进技术和Pnuvax Inc.已经投入使用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限制，**开发和验证大流行性流感疫苗的细胞培养生产平台**，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.