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Semi-absolute quantitative detection method for host cell protein in antibody drug

A technology for absolute quantification of host cell proteins, applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of high false positives, unclear detection components, etc., and achieve the effect of clear components, clear impurity content, and fast speed.

Pending Publication Date: 2020-06-30
上海中科新生命生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the detection of HCPs is mainly through the Elisa method, but the detection components of this method are not clear, and the false positives are high.

Method used

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  • Semi-absolute quantitative detection method for host cell protein in antibody drug
  • Semi-absolute quantitative detection method for host cell protein in antibody drug
  • Semi-absolute quantitative detection method for host cell protein in antibody drug

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Experimental program
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Embodiment Construction

[0024] The technical solution of the present invention will be described below with reference to the drawings and embodiments.

[0025] The iRT peptide sequence in this example is:

[0026] LGGNEQVTRYILAGVENSKGTFIIDPGGVIRGTFIIDPAAVIRGAGSSEPVTGLDAKTPVISGGPYEYRVEATFGVDESNAKTPVITGAPYEYRDGLDAASYYAPVRADVTPADFSEWSKLFLQFGAQGSPFLK.

[0027] The present invention provides a semi-absolute quantitative detection method for host cell proteins in antibody drugs. The host cell protein is used to establish a protein database, and then an antibody drug sample is combined with the host cell protein database for analysis. The antibody drug sample analysis includes taking the antibody drug sample and The internal standard protein is added as a reference to perform mass spectrometry analysis of data-independent collection to quantitatively detect the host cell protein in the antibody drug; the host cell protein database can be used for subsequent antibody drug detection of the same host cell.

[0028] Ta...

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Abstract

The invention discloses a semi-absolute quantitative detection method for host cell protein in an antibody drug. The method comprises the following steps: establishing a protein database by host cellprotein; taking an antibody drug sample to be combined with the host cell protein database for analysis, wherein antibody drug sample analysis comprises the steps that the antibody drug sample is taken, internal standard protein is added into the antibody drug sample to serve as a reference, mass spectrometric analysis of data non-dependence collection is conducted, and host cell protein in the antibody drug is quantitatively detected; the host cell protein database can be used for subsequent antibody drug detection of the same host cell, and the method has the advantages of clear components,clear impurity content, high flux, high speed and the like, and opens up a new way for detection of impurity proteins in antibody drugs.

Description

Technical field [0001] The invention relates to the technical field of biological detection, in particular to a method for semi-absolute quantitative detection of host cell protein in antibody drugs. Background technique [0002] Monoclonal antibody drugs have unique curative effects in tumors, rheumatoid arthritis, autoimmune diseases, etc., and they are used more and more clinically. Host Cell Proteins (HCPs) are one of the main impurities in antibody drugs, mainly from the secreted proteins of host cells and structural proteins of dead host cells. Trace amounts of impurity protein residues may cause severe immune reactions in the human body. Therefore, the impurity protein components contained in biopharmaceutical products and quality control are very important. At present, the detection of HCPs is mainly through the Elisa method, but this method has disadvantages such as unclear components and high false positives. Therefore, it is particularly urgent to develop a method fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72G01N30/86
CPCG01N30/02G01N30/06G01N30/72G01N30/8675G01N2030/045G01N2030/067
Inventor 张益
Owner 上海中科新生命生物科技有限公司
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