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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

Inactive Publication Date: 2015-08-19
上海泰因生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In Chinese Patent CN201210086437.2 "Treatment of Multiple Sclerosis (MS) with CAMPATH-1H", the inventors describe a method for the treatment of multiple sclerosis (MS) with Campath-1H, which has significant efficacy and beneficial safety , providing an acceptable benefit / risk ratio, but the patent does not mention detailed antibody preparation processes and methods
[0010] 2) Even with the precise control of physiochemical conditions through the reactor, this control method still lacks the precise regulation and control of the cell state itself
[0011] 3) The reproducibility of cells obtained in batch culture is low, and is greatly affected by the personal operation of different experiments and production technicians, and there will be large batch-to-batch variation in experiments and production. This is also one of the difficult problems in the field of drug quality control and supervision.
[0012] In addition, it is a colloquial expression to describe cells with "good" and "bad" cell states in traditional technology, and words such as "lag phase", "logarithmic growth phase" and "plateau phase" are also more general terms. concept, imprecise and accurate

Method used

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

Examples

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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...

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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.

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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12M1/36C12M1/34C12Q3/00C12P21/08
Inventor 齐念民
Owner 上海泰因生物技术有限公司
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