Apparatus and method for producing anti-Her-2 monoclonal antibodies through online industrially robust regulation of cell states

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-Her-2 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-Her-2 monoclonal antibody production can be achieved.

Description

technical field [0001] The present invention relates to a device and method for producing anti-Her-2 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 and continuous perfusion biological reaction The device and method for cell culture, expansion and preparation of anti-Her-2 monoclonal antibody can directly adjust and control the cell state on-line to adjust various physical and biochemical indicators in the cell culture environment of the device and the culture bottle / bag system. Background technique [0002] Breast cancer is a type of disease rather than a disease. Its occurrence involves the imbalance of apoptosis and proliferation, cell differentiation disorder, dysfunction of oncogenes and tumor suppressor genes, and abnormalities in various life activities such as related signal transduction systems. As an oncogene closely related to the metastasis an...

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Problems solved by technology

Although these recombinant protein production processes have been enlarged to more than 1000L, the process itself has the following disadvantages: 1) The parameters of the cultivation and expression process are less controlled, and the physical and chemical conditions of the culture environment such as temperature and pH cannot be fully or only partially controlled , CO 2 and O 2 concentration, nutrient concentration, etc.; 2) Even if the physical, biological and chemical conditions are precisely controlled by the reactor, this control method still lacks the precise regulation and control of the cell state itself

[0020] 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

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