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Method for detecting adalimumab content in human plasma

A technology of adalimumab and detection method, which is applied in the field of detection of adalimumab content, can solve the problem of no safety signal of adverse reactions, etc., and achieve the effect of easy operation, good accuracy and precision, and high specificity

Pending Publication Date: 2021-01-12
上海熙华检测技术服务股份有限公司
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Problems solved by technology

[0003] In 2013, through the study of adverse events in clinical trials of adalimumab for various indications in the past 12 years, no new safety signals of adverse reactions beyond previous experience were found

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0034]Embodiment: instruments and materials: EDTA plasma or serum, hTNF antigen, anti-human IgG (H+L)-HRP, styrene 96-well plate, adalimumab fermentation broth, blank cell strain fermentation broth, auxiliary solution; reagents Configuration: Dilute adalimumab injection to 1ng / ml, and then serially dilute to the desired concentration; content detection: Dilute hTNF antigen with pH9.6 coating buffer and coat styrene 96-well plate, Overnight at 4°C, wash the plate 3 times, pat dry, add 200 μL / well of blocking solution, block at room temperature for 2 hours, wash the plate 3 times, pat dry, add 100 μL of different concentrations of standards or samples to be tested, incubate at 37°C for 1 hour, wash the plate 6 times, pat dry, add detection antibody 1:10000, 100 μL / well, incubate at room temperature for 1 h, wash the plate 6 times, pat dry, add TMB chromogenic solution 100 μL / well, incubate at room temperature for 15 min, add stop solution 100 μL / well, measure OD450 value; 0.5μg / ...

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Abstract

The invention relates to the technical field of adalimumab content detection, in particular to a method, instrument and material for detecting adalimumab content in human plasma, which comprise EDTA (ethylene diamine tetraacetic acid) plasma or serum, hTNF (human tumor necrosis factor) antigen, human IgG (H + L) HRP (immunoglobulin G + L), styrene 96-well plate, adalimumab fermentation liquor, blank cell strain fermentation liquor and auxiliary solution, according to the method, a corresponding antigen is used for coating, If the adalimumab is detected, the hTNF antigen is selected as a coating antigen, so that the specificity is very high, and meanwhile, the protein content measured by an immunological method and a physicochemical method is compared, so that the relevant information of the proportion of the protein with specific binding activity in the total protein can be obtained; however, in the process of determining the content of the monoclonal antibody in the monoclonal antibody product by the method, the content and activity of a standard substance need to be accurately calibrated, and the method is easy to operate, has good accuracy and precision, can be used for determining the content of the adalimumab, and provides methodological basis for rapid quantitative detection of the recombinant monoclonal antibody.

Description

technical field [0001] The invention relates to the technical field of adalimumab content detection, in particular to a detection method for adalimumab content in human plasma. Background technique [0002] Adalimumab (Humira) is a biotherapeutic drug that can be injected by itself. It has been approved by the State Food and Drug Administration (CFDA) for two indications, namely rheumatoid arthritis and ankylosing spine. inflammation. [0003] In 2013, through the study of adverse events in clinical trials of adalimumab for various indications in the past 12 years, no new safety signals of adverse reactions beyond previous experience were found. Among adalimumab-treated patients, overall malignancy rates were as expected in the general population. This drug is usually used alone or in combination with methotrexate. [0004] In order to better detect the content of adalimumab in human plasma, a method for detecting the content of adalimumab in human plasma is proposed. C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/58G01N33/545G01N33/543
CPCG01N33/54393G01N33/545G01N33/577G01N33/581G01N33/94G01N2333/525
Inventor 邢金松李浩
Owner 上海熙华检测技术服务股份有限公司
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