A purification process of monoclonal antibody

Abstract

The invention discloses a purification process of monoclonal antibodies. The purification process comprises: firstly, carrying out three-time volume of dilution on a protein sample through adopting a weak acid buffering solution; adjusting the pH (Potential of Hydrogen) value to 4.2 to 4.4 and then carrying out isoelectric precipitation; filtering by adopting a filter with a pore diameter of 0.22mu m to 0.45mu m; adjusting the pH value to be neutral; salting out by adopting neutral salt; directly filtering treated protein liquid through adopting a filter with the pore diameter of 0.05mu m to 0.22mu m; removing supernatant and remaining sediment and enriching; redissolving the enriched sediment by adopting a neutral phosphate solution, wherein the concentration of protein after redissolving is 15mg / ml to 20mg / ml; carrying out dynamic dialysis and measuring the content of the protein, and then subpackaging and storing. The purification process of the monoclonal antibodies, provided by the invention, has a simple flow and is convenient to operate and high in safety; high purity (90 percent or more) and high recovery rate (95 percent or more) of target proteins can be guaranteed, and the cost is low, so that the purification process can be used for industrial large-scale production.

Description

technical field [0001] The invention relates to protein purification in biomedicine technology, in particular to a purification process of monoclonal antibody in protein purification. Background technique [0002] In 1975, Kohler and Milstein invented monoclonal antibody technology, but it was not until 1987 that the value of monoclonal antibody technology was recognized and applied to diagnostic reagents. At present, monoclonal antibodies are mainly used in the prevention, diagnosis and treatment of diseases, the purification of biological substances and the study of protein structure and function. The market for therapeutic monoclonal antibodies has a tendency to increase year by year in the development of new drugs. In 1997, the sales of monoclonal antibodies were 5 billion US dollars, with an annual growth rate of 40% to 50%. By 2003, it had reached ten times that of 1997. It can be seen that monoclonal antibody technology is a rising star in the field of biotechnology....

AI Technical Summary

Problems solved by technology

[0006] At present, there are many purification methods for monoclonal antibodies. Although the cost of the routinely used salting-out purification method is low, it is prone to low yield and unqualified purity; while the process of using other chromatography techniques involves various active materials such as fillers, resulting in higher purification costs and complicated processes, which are not conducive to industrial production, resulting in higher costs for clinical trials and medicines