An Affinity Column for Influenza Virus Vaccine Manufacturing

用于流感病毒疫苗生产的亲和柱

• 批准号: 7325530
• 负责人: XING-XIANG LI
• 金额: $ 22.48万
• 依托单位: CELLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-15 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7325530
• 关键词: Affinity; Animals; Avian Influenza A Virus; Binding; Biological Assay; Biomanufacturing; Cell Culture Techniques; Cells; Cessation of life; Characteristics; Coupled; Coupling; Culture Media; Cultured Cells; Data; Developed Countries; Developing Countries; Dose; Economics; Enzyme-Linked Immunosorbent Assay; Facility Construction Funding Category; Flu virus; Gel; Gel Chromatography; Genetic Engineering; Genome; Hemagglutination; Hemagglutinin; Human; Immune response; Immunoglobulin G; Influenza; Intervention; L Cells; Magnetism; Measures; Medical Surveillance; Methods; Monitor; Mus; Numbers; Performance; Phase; Phase I Clinical Trials; Plant Resins; Polymers; Polysialic Acid; Population; Process; Proteins; Quality Control; Research; Role; Sampling; Scheme; Sepharose; Sialic Acids; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solid; Solutions; System; T-Cell Proliferation; Technology; Testing; Use of New Techniques; Vaccination; Vaccine Production; Vaccines; Viral Proteins; Virus; Western Blotting; base; cost; cytokine; egg; immunogenicity; influenza virus vaccine; influenzavirus; manufacturing process; pandemic disease; pandemic influenza; particle; positional cloning; prevent; receptor; scale up; size; transmission process; vaccine development; virus culture

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.

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。当偶联到固体载体如磁性颗粒或琼脂糖上时，聚合物可用于从大体积样品中分离和浓缩流感病毒。与该聚合物偶联的固体支持物的一个应用是其在流感疫苗制造期间用于纯化流感病毒，特别是用于纯化源自培养细胞的流感病毒。我们建议将聚合物与适合生物制造的树脂偶联，该树脂将用于包装流感病毒纯化柱。对于I期研究，我们将构建几个100 mL色谱柱，并使用在5-10 L细胞培养基中繁殖的流感病毒进行验证。将使用一系列QC检测评价柱纯化病毒的纯度，并使用动物评价其免疫原性。流感病毒纯化柱如果成功开发，将可能取代在发达国家广泛使用但设置和操作昂贵的连续流离心系统，以及由于成本低而在发展中国家普遍使用但产生被污染蛋白质或其他材料高度污染的疫苗的凝胶过滤方法。