An Affinity Column for Influenza Virus Vaccine Manufacturing

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.