Lyophilized preparation of anti-human Her2 antibody

Abstract

The invention provides a preparation method of a lyophilized preparation of an anti-human Her2 antibody. The lyophilized preparation of the anti-Her2 antibody is prepared from the anti-Her2 antibody, a protective agent, excipient and buffer salts through lyophilization. The lyophilized preparation of the anti-Her2 antibody has the advantages of good stability, prolonged valid period, and easy storage and transportation.

Description

technical field [0001] The invention belongs to the field of biotechnology and relates to a stable anti-Her2 monoclonal antibody freeze-dried preparation. Background technique [0002] Her2 receptor is one of the four members of the human epidermal growth factor receptor family, and is expressed in various tumors such as breast cancer, ovarian cancer, gastric cancer, bladder cancer, and non-small cell lung cancer. Overexpression of Her2 will increase the ability of tumor cells to invade and metastasize. Therefore, the level of Her2 expression is closely related to the clinical diagnosis, drug efficacy and prognosis of breast cancer and ovarian cancer. specific target. [0003] Humanized anti-HER2 antibodies are produced by mammalian cells (Chinese hamster ovary cells CHO) suspended in sterile medium and purified by affinity chromatography and ion exchange, including removal of specific virus inactivation program. Anti-Her2 antibody is a humanized monoclonal antibody deriv...

AI Technical Summary

Problems solved by technology

[0007] James D. Andia; Wei Junxiang; Liu Jun; Shen Ye invented the liquid preparation of anti-Her2 antibody protein (patent name: antibody preparation in histidine-acetate buffer, Patent No.: 200580043463.5) Its shortcoming is that the protein in the form of liquid preparation is more prone to physical and chemical reactions, such as deamidation reaction, oxidation or hydrolysis by other substances, and secondly, when the concentration of protein in aqueous solution is too high Easy to aggregate, easy to produce immune response after injection into the human body

More importantly, during the long-distance transportation of liquid preparations, severe shocks will easily denature proteins and lose their activity

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