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Method for purifying anti-PD-1 antibody

A PD-1 and antibody technology, applied in the field of purification process of anti-PD-1 antibody, can solve the problems of long research and development cycle, high technical difficulty, etc., and achieve the effect of simple operation, mild elution conditions and fast speed

Pending Publication Date: 2021-05-28
SUZHOU SUNCADIA BIOPHARM CO LTD
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

As a biological macromolecule, antibody drugs are technically difficult to develop and have a long development cycle

Method used

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  • Method for purifying anti-PD-1 antibody

Examples

Experimental program
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specific Embodiment approach

[0066] Further description below in conjunction with the examples, but the scope of the examples is not limited.

[0067] For the experimental methods that do not specify specific conditions in the examples or test examples, usually follow the conventional conditions, or follow the conditions suggested by the raw material or commodity manufacturers. See Sambrook et al., Molecular Cloning, A Laboratory Manual, Cold Spring Harbor Laboratory; Methods in Current Molecular Biology, Ausubel et al., Greene Publishing Associates, Wiley Interscience, NY. Reagents without specific sources indicated are conventional reagents purchased in the market.

Embodiment 1

[0069] Load the cell clarified solution containing anti-PD-1 monoclonal antibody to the MabSelect PrismA affinity chromatography column according to the amount of 40g / L filler, and wash the affinity chromatography column with pH 7.0 20mM phosphoric acid + 1M sodium chloride buffer solution 5 times the column volume, eluted with 50mM citrate buffer at pH 3.0, collected the affinity collection solution, and incubated for 90min to complete low-pH virus inactivation. Adjust the pH of the low-pH virus inactivation solution to 5.0, filter to obtain a low-pH virus inactivation neutralization solution, and then load it on the Capto Q chromatography column according to the amount of 150 mg / mL filler, and collect the anion chromatography flow-through. Load the anion chromatography flow-through liquid to the Fractogel EMD SO3-(M) chromatography column according to 90mg / mL filler, wash the cationic chromatography column with 20mM citric acid buffer solution at pH 5.0 for 5 column volumes, ...

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Abstract

The invention relates to a method for purifying an anti-PD-1 antibody. Specifically, the purification method comprises the following steps: removing pollutants by using methods such as affinity chromatography, virus inactivation, anionic membrane chromatography, cation exchange chromatography and the like. The process can reduce the production cost and improve the antibody yield.

Description

technical field [0001] The present disclosure belongs to the field of bioengineering, and specifically relates to a purification process of anti-PD-1 antibody, including using methods such as affinity chromatography, virus inactivation, anion membrane chromatography, and cation exchange chromatography to remove pollutants. [0002] technical background [0003] Antibody drugs are currently the most promising biotechnological drugs. They have the advantages of good targeting, strong specificity, and low toxic and side effects. They are mainly used for the treatment of malignant tumors and autoimmune diseases. The global monoclonal antibody market continues to increase and has become the focus of competition for biopharmaceuticals in various countries. [0004] In recent years, domestic pharmaceutical companies have also accelerated the deployment of antibody drugs. As biological macromolecules, antibody drugs are technically difficult to develop and have a long development cy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28C07K1/22C07K1/18
CPCC07K16/2818C07K2317/56C07K2317/565
Inventor 童红飞王宏伟尹生于月娇
Owner SUZHOU SUNCADIA BIOPHARM CO LTD
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