An Affinity Column for Influenza Virus Vaccine Manufacturing

描述（由申请人提供）：我们发现了一种特异性和有效结合流感病毒的聚合物。当与磁性颗粒或琼脂糖等固体载体耦合时，这种聚合物可用于从大量样本中分离和浓缩流感病毒。与该聚合物偶联的固体载体的一个应用是在流感疫苗生产过程中用于流感病毒的纯化，特别是来自培养细胞的流感病毒。我们建议将聚合物偶联到一种适合生物制造的树脂上，这种树脂将用于包装流感病毒纯化柱。对于I期研究，我们将建立几个100 mL的柱，将使用在5-10 L细胞培养基中繁殖的流感病毒进行验证。柱式纯化病毒将通过一系列QC测试和动物免疫原性来评估其纯度。流感病毒净化柱如果开发成功，将有可能取代在发达国家广泛使用的连续流动离心系统和凝胶过滤方法。连续流动离心系统在发达国家广泛使用，但设置和操作费用昂贵，而凝胶过滤方法在发展中国家普遍使用，因为成本低，但生产的疫苗被污染蛋白或其他物质高度污染。

DESCRIPTION (provided by applicant): We have found a polymer that specifically and efficiently binds to influenza viruses. When coupled to a solid support such as magnetic particles or agarose, the polymer could be used to isolate and concentrate flu virus from a large volume sample. One application for the solid support coupled with this polymer is its use for purification of flu virus during flu vaccine manufacturing, particularly for flu virus derived from cultured cells. We propose to couple the polymer to a resin appropriate for biomanufacturing, which will be used to pack flu virus purification columns. For Phase I study, we will build several 100 mL columns, which will be validated using flu virus propagated in 5-10 L cell culture medium. The column-purified virus will be evaluated in terms of its purity using an array of QC tests, and immunogenicity using animals. The flu virus purification columns, if successfully developed, will likely replace the continuous flow centrifugal system, which is widely used in developed countries but is expensive to set up and operate, and gel filtration method, which is commonly used in developing countries because of low cost but generates vaccines that are highly contaminated with contaminant proteins or other materials.