Apparatus and method for producing anti-CD52 monoclonal antibodies through online industrially robust regulation of cell states

A cell state, industrially robust technology, applied in biochemical cleaning devices, biochemical equipment and methods, enzymology/microbiology devices, etc., can solve the lack of precise regulation and control of cell state, antibody preparation process and method, inaccuracy and accuracy, etc., to reduce the risk of bacterial contamination, maintain stability, and maintain growth vigor

CN104845881AInactive Publication Date: 2015-08-19上海泰因生物技术有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2015-08-19
Estimated Expiration
Not applicable · inactive patent

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Abstract

The present invention discloses a bioreactor cell culture apparatus capable of onlinely and continuously monitoring physiological and biochemical indexes in a variety of cell culture environments and directly regulating and controlling cell states (including cell cycle and the like), and a method for producing anti-CD52 monoclonal antibodies through the apparatus. With the apparatus and the method of the present invention, the bacterial pollution risk during the cell culture process can be reduced, the stable cell growth environment can be maintained, the constant cell growth viability can be maintained, and the high-quality, high-efficiency and continuous anti-CD52 monoclonal antibody production can be achieved.
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Description

technical field

[0001] The present invention relates to a device and method for producing anti-CD52 monoclonal antibody by adjusting and controlling cell state on-line in the field of bioengineering, in particular to an on-line industrially robust continuous monitoring, continuous perfusion bioreactor and The device and method for cell culture, expansion and preparation of anti-CD52 monoclonal antibody can directly adjust and control cell state on-line for various physical and biochemical indicators in the cell culture environment of the culture bottle / bag system. Background technique

[0002] Anti-CD52 monoclonal antibody, trade name Campath, is an anti-CD52 humanized monoclonal antibody expressed by recombinant DNA transfected CHO cells, with human antibody framework region and constant region and mouse complementarity determining region (CDR) IgG1 kappa antibody. Antibody construction is to insert the heavy chain and light chain CDRs of anti-human CD52 murine monoclonal ...

Examples

example 1

[0088] Example 1. The method for the production of anti-CD52 monoclonal antibody by the on-line industrially robust (industrially robust) regulation and control of the CHO cell state bioreactor

[0089] The relevant reagents and devices used in this example are as follows:

[0090] Culture medium: Excell CD CHO serum-free medium produced by Sigma, USA;

[0091] Cells: CHO cell stable strain expressing recombinant anti-CD52 monoclonal antibody;

[0092] Monitorable cell bioreactor: 7L animal cell reactor produced by Applicon in the Netherlands, with a working volume of 5L;

[0093] Online monitoring system: the control tower produced by Applicon Company in the Netherlands.

[0094] The method for producing anti-CD52 monoclonal antibody in this example is as follows:

[0095] 1) On the control tower produced by Applicon Company in the Netherlands, the temperature is set at 37°C, the pH value is 7.1, the dissolved oxygen concentration is 45%, and the dissolved carbon dioxide c...

example 2

[0104] Example 2. Production of anti-CD52 monoclonal antibody by online industrially robust regulation of transient expression process of gene transfection in bioreactor

[0105] The reagents and instruments used in this example are as follows:

[0106] Culture medium: Excell293 serum-free medium produced by Sigma, USA;

[0107] Cells: acclimatized HEK293 cell line in serum-free suspension;

[0108] Monitorable cell bioreactor: 3L animal cell reactor produced by Applikon in the Netherlands, with a working volume of 2.1L;

[0109] Online monitoring system: the control tower produced by Applicon Company in the Netherlands.

[0110] The method for producing anti-CD52 monoclonal antibody in this example is as follows:

[0111] 1) On the control tower produced by Applikon in the Netherlands, the temperature is set at 37°C, the pH value is 7.4, the dissolved oxygen concentration is 40%, and the dissolved carbon dioxide concentration is 5%. The temperature is controlled by a const...