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A fully-closed pipeline protein purification system and its application in the preparation of sterile pyrogen-free protein drugs

A protein purification and fully enclosed technology, applied in the field of protein purification, can solve the problems of restricting protein drugs, and achieve the effect of reasonable design, tight connection and easy expansion

Inactive Publication Date: 2015-11-25
INSITUTE OF BIOPHYSICS CHINESE ACADEMY OF SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, for drugs in the preclinical research stage, this will be a considerable expense and burden, often limiting the translation of protein drugs with potential therapeutic value from laboratory research to clinical research

Method used

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  • A fully-closed pipeline protein purification system and its application in the preparation of sterile pyrogen-free protein drugs
  • A fully-closed pipeline protein purification system and its application in the preparation of sterile pyrogen-free protein drugs
  • A fully-closed pipeline protein purification system and its application in the preparation of sterile pyrogen-free protein drugs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1: The composition and assembly of a fully closed pipeline protein purification system

[0063] The fully-enclosed pipeline protein purification system of the present invention is aimed at the post-expression separation and purification process of soluble secreted and expressed genetically engineered proteins, and includes hardware modules for respectively performing process steps such as microfiltration clarification, chromatography purification, ultrafiltration concentration, and dosage forms. . The technical key point and innovation point of the present invention is to assemble the process steps and hardware that were separated and semi-closed in the past into a fully closed process and hardware system that can be operated continuously in sequence through appropriate connection tools. like figure 1 As shown, the composition and assembly of the purification system includes the following specific contents:

[0064] First, the hardware module for performing th...

Embodiment 2

[0070] Example 2: A fully closed pipeline system suitable for humanized anti-CD146 monoclonal antibody and a pilot-scale aseptic and pyrogen-free purification preparation process

[0071] Figure 5 It is a schematic diagram of the assembly of the fully closed pipeline protein purification system combined with the humanized anti-CD146 monoclonal antibody purification process described in the present invention. As shown in the figure, the system is in the order of process, followed by a microfiltration module based on a hollow fiber column with a pore size of 0.45 μm, and an affinity chromatography medium based on Protein A ligand (GE healthcare Bio-Sciences Corp. Product Code: 17-5474-02) Capture chromatography module, fine chromatography module based on Superdex200 (GEhealthcareBio-SciencesCorp.ProductCode: 17-1043-01) gel filtration chromatography medium and ultrafiltration module based on 50kD molecular weight cut-off hollow fiber column; The method described in Embodiment ...

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Abstract

The invention relates to a full sealed pipelined protein purification system and a method of a purification sterile apyrogeneity humanization anti-CD146 monoclonal antibody based on the full sealed pipelined protein purification system.

Description

technical field [0001] The present invention relates to the field of protein purification. Specifically, the present invention relates to a fully-closed pipeline protein purification system and a method for purifying sterile pyrogen-free humanized anti-CD146 monoclonal antibody based on the purification system. Background technique [0002] Compared with traditional chemical drugs, protein drugs have the advantages of strong specificity, low toxicity, clear biological functions, and favorable clinical application. In the process of protein drug development, how to separate and purify it from the complex expression system has become an important and unavoidable link. [0003] In the traditional protein purification method, in the stages of sample pretreatment, chromatographic purification and formulation process, many links have to be operated in an open environment, so that the sample is directly exposed to the air, which greatly increases the risk of bacterial contaminatio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K1/36C07K1/34C07K1/16C07K16/28
Inventor 阎锡蕴王飞冯静杨东玲卢迪宋丽娜
Owner INSITUTE OF BIOPHYSICS CHINESE ACADEMY OF SCIENCES
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