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，以建立能力并实施应对流感大流行的准备计划。在流感大流行期间，** 国家对其本国人口的疫苗需求增加，因此必须 ** 迅速提供匹配疫苗。然而，目前以鸡蛋为基础的生产工艺要满足 ** 预期的疫苗需求可能存在很大问题，例如在 ** 禽流感病毒株可能破坏鸡蛋供应链的情况下。因此，根据国家和国际卫生当局关于开发替代 ** 和补充技术以便在紧急情况下作出快速有效反应的建议，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植物生产 ** 平台。目前在加拿大，只有一家制造商 ** 使用基于鸡蛋的生产技术生产流感疫苗。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准备计划，以应对流感潜在的大流行病和其他新出现的传染病，加拿大投资于细胞培养生产的病毒疫苗能力具有高度战略意义，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 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.