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Chromatography column with reduced model and preparation method thereof

A technology for reducing model and chromatography column, applied in the field of antibody purification, can solve problems such as high cost and serious column wall effect, and achieve the effect of good column efficiency, alleviation of column wall effect, and simple operation.

Active Publication Date: 2021-01-22
HJB HANGZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] The first purpose of the present invention is to provide a reduced-model chromatographic column to solve the technical problems of serious column wall effect and high cost in the prior art

Method used

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  • Chromatography column with reduced model and preparation method thereof
  • Chromatography column with reduced model and preparation method thereof
  • Chromatography column with reduced model and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] This embodiment provides a method for preparing a chromatographic column of a reduced model, comprising the following steps:

[0040] (1) Take an Omnifit EZ Column, a chromatography column with a diameter of 6.6mm and a height of 250mm, and prepare a corresponding empty column tube and column packing device at the same time, clean it; remove the telescopic column head of the Omnifit chromatography column , and then connect the Omnifit chromatography column to the empty column tube through the column packer;

[0041] (2) Fix the chromatography column vertically, resuspend the filler homogenate (MabSelect SuRe LX) after the calculated volume and pour it into the chromatography column, using an aqueous solution of ethanol with a mass fraction of 20% as the column packing liquid, Quickly fill up the chromatography column with packing liquid, install the column head, wash the chromatography column with packing liquid at a flow rate of 1000cm / h, after the height of the column...

Embodiment 2

[0043] This embodiment provides a method for preparing a chromatographic column of a reduced model, comprising the following steps:

[0044](1) Take an Omnifit EZ Column, a chromatography column with a diameter of 6.6mm and a height of 250mm, and prepare a corresponding empty column tube and column packing device at the same time, clean it; remove the telescopic column head of the Omnifit chromatography column , and then connect the Omnifit chromatography column to the empty column tube through the column packer;

[0045] (2) Fix the chromatography column vertically, resuspend the filler homogenate (POROS 50HQ) after the calculated volume and pour it into the chromatography column, use an aqueous solution of ethanol with a mass fraction of 25% as the column liquid, and quickly Fill up the chromatography column with packing liquid, install the column head, wash the chromatography column with packing liquid at a flow rate of 1200cm / h, after the height of the column bed is stable...

Embodiment 3

[0047] This embodiment provides a method for preparing a chromatographic column of a reduced model, comprising the following steps:

[0048] (1) Take an Omnifit EZ Column, a chromatography column with a diameter of 6.6mm and a height of 250mm, and prepare a corresponding empty column tube and column packing device at the same time, clean it; remove the telescopic column head of the Omnifit chromatography column , and then connect the Omnifit chromatography column to the empty column tube through the column packer;

[0049] (2) Fix the chromatography column vertically, resuspend the filler homogenate (POROS 50HQ) after the calculated volume and pour it into the chromatography column, use an aqueous solution of ethanol with a mass fraction of 30% as the column liquid, and quickly Fill up the chromatography column with packing liquid, install the column head, wash the chromatography column with packing liquid at a flow rate of 800cm / h, record the height of the column bed after th...

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Abstract

The invention relates to the technical field of antibody purification, in particular to a chromatographic column of a miniature model and a preparation method thereof. The chromatographic column of the miniature model comprises a chromatographic column body and chromatographic filler filling the chromatographic column body. A packing liquid is an aqueous solution of ethanol. By taking the aqueoussolution of ethanol as the packing liquid, the chromatographic filler is packed in the chromatographic column body. By taking the aqueous solution of ethanol as the packing liquid, the column wall effect of the chromatographic column can be alleviated effectively. Through a column efficiency test, the qualified chromatographic column of the miniature model is obtained. The preparation method of the chromatographic column is simple to operate, easy to pack and free of tedious steps such as replacing a buffer solution.

Description

technical field [0001] The invention relates to the technical field of antibody purification, in particular to a reduced-model chromatographic column and a preparation method thereof. Background technique [0002] The goal of antibody manufacturing process validation is to demonstrate that it is capable of producing antibody products of appropriate quality and consistent stability when operated within defined limits. Due to the complexity of the antibody and its production process, only passing the finished product inspection cannot fully guarantee the continuous stability of production. Therefore, the antibody production process must be designed and validated to prove that a process is effective and reproducible, and that the finished product it produces meets the requirements of established release standards. [0003] In process validation, it is very valuable to develop a scale-down model that uses a laboratory-scale model to simulate a commercial production scale. Firs...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B01D15/22C07K16/00C07K1/22C07K1/20C07K1/18
CPCB01D15/22C07K16/00
Inventor 汤炜金雄华徐志豪
Owner HJB HANGZHOU CO LTD
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