Cell culture process for improving ADCC activity of antibody

A cell culture and process technology, applied in the direction of anti-receptor/cell surface antigen/cell surface determinant immunoglobulin, cells modified by introducing foreign genetic material, anti-animal/human immunoglobulin, etc., to achieve stability Good, strong operability, and the effect of improving cell viability

Pending Publication Date: 2020-12-01
百济神州(苏州)生物科技有限公司
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a production process for effectively improving antibody ADCC activity in the cell culture process, so as to solve the defects in the existing cell culture process

Method used

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  • Cell culture process for improving ADCC activity of antibody
  • Cell culture process for improving ADCC activity of antibody
  • Cell culture process for improving ADCC activity of antibody

Examples

Experimental program
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Embodiment 1

[0059] The cells used are CHO cells (constructed by BeiGene), which contain expression vectors and can secrete monoclonal antibodies. A cell (built by BeiGene) was taken from the cell bank, and quickly thawed in a 37°C water bath with rapid shaking, and the thawing time was controlled within 3 minutes. Actipro basal medium (containing 25nm MSX) purchased from GE was used for resuscitation, the resuscitation density was controlled within the range of 0.5±0.1*10^6 cells / mL, placed on a shaker at 130rpm, CO2 concentration 5% (volume), and 36.5°C Cultured in medium for 3 days, when the density reached 2.5*10^6cells / mL, subculture and expansion began, and the seeding density was 0.4±0.1*10^6cells / mL. Several successive passages were carried out, and then inoculated into an XDR10 reactor (purchased from GE) for Fed-batch culture, and the temperature was lowered.

[0060] The parameters of the XDR10 reactor were set as follows: the temperature from the beginning of cultivation to th...

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Abstract

The invention provides a cell culture process for effectively improving the ADCC activity of an antibody. The cell culture process comprises the following steps: i) adding mammalian cells expressing amonoclonal antibody or a fragment thereof and a basic medium into a bioreactor, and setting the culture temperature of the bioreactor as t1; ii) after culturing for a period of time, feeding a fed-batch medium into the bioreactor; and iii) after culturing for a period of time, reducing the culture temperature of the bioreactor to t2. The process can significantly improve the ADCC activity of theantibody while improving the viability during harvesting, has the characteristics of good stability, strong operability, small batch-to-batch difference and the like, and is easy to apply to large-scale CHO cell expression monoclonal antibodies, especially to industrial production of monoclonal antibodies.

Description

technical field [0001] The invention discloses a cell culture process, more specifically relates to a cell culture process using CHO cells to express monoclonal antibodies, which can improve the ADCC activity of monoclonal antibodies, and belongs to the field of biological products. Background technique [0002] Biotechnology drugs, especially monoclonal antibody drugs, have been highly recognized in the market after they are launched because of their targeting and tolerance, improving the quality of life of patients and prolonging their lives. Since the first monoclonal antibody drug Muromonab CD3 was approved by the FDA in 1986, antibody drugs have achieved rapid development in the clinical treatment of malignant tumors, autoimmune diseases, cardiovascular diseases, organ transplant rejection and infection, leading the second A wave of biomedical products. As of May 2018, more than 80 therapeutic antibody drugs have been approved in Europe and the United States. The aver...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N5/10C07K16/28C12R1/91
CPCC07K16/2878C07K2317/732
Inventor 裴新姚小员靳孝庆徐凯李金美李学宁王雅丽李海鹰李渝成
Owner 百济神州(苏州)生物科技有限公司
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