Method for producing humanized monoclonal antibody using animal mammary gland bioreactor

Abstract

The invention discloses a method for producing a humanized monoclonal antibody using an animal mammary gland bioreactor. The method comprises the following steps: leading an antibody heavy chain coding gene with a homing sequence at a 5'terminal and an antibody light chain coding gene with a homing sequence at the 5' terminal into a mammal somatic cell to obtain a transgenic cell for antibody expression; taking the transgenic cell as a nuclear transfer donor cell and an oocyte as a nuclear transfer recipient cell, and acquiring a cloned embryo by a nuclear transfer technology; and finally shifting the cloned embryo into livestock uterus for pregnancy by a non-operative method to obtain transgenic livestock, and then producing the monoclonal antibody by the transgenic livestock. In the method, the nucleotide sequence of the homing sequence is sequence 1 in a sequence table. The method for producing the humanized monoclonal antibody using the animal mammary gland bioreactor of the invention has low cost, high antibody yield and important economic and social values.

Description

technical field [0001] The invention relates to a method for producing a humanized monoclonal antibody using an animal mammary gland bioreactor. Background technique [0002] Since the advent of B lymphocyte hybridoma cell fusion technology in 1975, after more than 30 years of development, monoclonal antibodies, as a class of drugs for clinical prevention and treatment, have shown increasingly important roles in medical treatment. At the same time, the fast-growing therapeutic antibody market is also driving a wide range of applications of monoclonal antibodies. In 2002, the global sales of monoclonal antibody drugs reached 5.4 billion US dollars, in 2004 it reached 10.3 billion US dollars, and it is estimated that by 2010 it will reach 30.3 billion US dollars, which will account for 32% of the profits of the biotechnology industry. At present, most commercialized antibodies are expressed by mammalian cell lines, but the production of antibodies expressed by cells is limite...

AI Technical Summary

Problems solved by technology

At present, most commercial antibodies are expressed by mammalian cell lines, but the production of antibodies expressed by cells is limited (0.1-1 g / L), and large-scale production will inevitably bring expensive production costs

In addition, the purification process in the later stage is complicated, and the expression level and activity of different batches of produced antibodies may be different

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