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. |