Process of cloning and further purification to make a recombinant intravenous immunoglobulin

Abstract

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 screeningof 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.

Description

technical field [0001] This patent application claims priority to US Provisional Patent Application No. 62 / 142,237, filed April 2, 2015, which was filed by the present inventors and is incorporated herein by reference in its entirety. [0002] This subject matter relates to recombinant intravenous immunoglobulin (IVIG) and protein sequences. In particular, the present subject matter relates to methods of cloning and purifying IVIG to produce purified recombinant IVIG in liquid and lyophilized form containing five newly discovered proteins, namely KH 33, KH 34, KH 35, KH 36 and KH 37 . Background technique [0003] Immunoglobulin G (IgG) is an antibody and is a protein complex consisting of four peptide chains, two identical heavy chains and two identical light chains, arranged in typical antibody monomers the Y shape. Each IgG has two antigen binding sites. IgG, representing approximately 75% of human serum antibodies, is the most common type of antibody in the circulati...

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However, a certain percentage of IgG may

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