发明名称 PROCESS OF CLONING AND FURTHER PURIFICATION TO MAKE A RECOMBINANT INTRAVENOUS IMMUNOGLOBULIN
摘要 The present subject matter is directed to a process of cloning and purifying recombinant intravenous immunoglobulin (IVIG), comprising cloning a target gene of human immunoglobulin; in vitro screening of a yeast cell expressing the target gene of human immunoglobulin to create a yeast cell line; fermenting the yeast cell line and collecting a resulting culture medium; filtering the culture medium; undergoing weak anion exchange chromatography to collect a flow-through solution; ultra-filtrating the flow-through solution to reach a desired protein concentration; aseptic filtrating the flow-through solution; nano filtrating the flow-through solution for virus removal; and filling and incubating the flow-through solution at low pH for virus inactivation to obtain a purified recombinant IVIG. The present subject matter is directed to purified recombinant IVIG having five newly-found proteins, namely KH 33, KH 34, KH 35, KH 36, and KH 37 for both liquid and lyophilized forms.
申请公布号 WO2016161423(A1) 申请公布日期 2016.10.06
申请号 WO2016US25873 申请日期 2016.04.04
申请人 HOANG, Kieu 发明人 HOANG, Kieu
分类号 A61K36/899;A61K38/17;A61K38/38 主分类号 A61K36/899
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