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Method for detecting tissue cross-reactivity of monoclonal antibody drugs using fresh frozen tissues

A monoclonal antibody and cross-reaction technology, which is used in testing pharmaceutical preparations, preparation of samples for testing, measurement devices, etc. Value, effect of reducing difficulty

Active Publication Date: 2018-05-25
WUXI APPTEC SUZHOU +2
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

[0004] Tissue specimens with immune tissue cross-reactivity mainly include paraffin sections and frozen sections. However, in the test, those who require frozen sections may not be able to make paraffin sections, because high-temperature drying is required for paraffin sections, which may destroy the antigenicity of the tissue. Moreover, paraffin sectioning includes a series of steps including material collection, fixation, dehydration, transparency, embedding, sectioning, staining, and sealing. The immune activity of the tissue antigen is weak, the slice quality is not high, and the slices are seriously peeled off, etc.

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  • Method for detecting tissue cross-reactivity of monoclonal antibody drugs using fresh frozen tissues

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Embodiment Construction

[0036] The method for using fresh frozen normal cynomolgus monkey tissue to detect tissue cross-reactivity of a monoclonal antibody drug manufactured by a pharmaceutical company—biotinylated mouse anti-human CD34 monoclonal [QBEND / 10] antibody (ab30375) comprises steps :

[0037] 1) Fresh frozen cynomolgus monkey tissue collection

[0038] The tissues of normal and healthy cynomolgus monkeys were extracted one by one using dissection techniques, and excess fat and fibers in the tissues were removed to ensure the integrity and cleanliness of the tissues. Before dissection, the cynomolgus monkeys were bled to avoid ice crystals during tissue sectioning and facilitate the preparation of slices. Among them, jugular vein bloodletting may be used as the bloodletting method.

[0039] 2) Preparation of fresh frozen tissue specimens

[0040] Fill the liquid nitrogen tank with liquid nitrogen, fill the stainless steel beaker with isopentane at a height of about 5 cm, use the iron sta...

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Abstract

The invention discloses a method used for detecting monoclonal antibody drug tissue cross-reactivity with fresh frozen tissues. The method comprises following steps: 1) fresh frozen tissues are collected; 2) fresh frozen tissue samples are prepared; 3) the fresh frozen tissue samples are made into fresh frozen tissue slices; and 4) the fresh frozen tissue slices are used for detecting monoclonal antibody drug tissue cross-reactivity. The method is capable of improving frozen tissue slice-making technology and slice-making quality, reducing difficulty of immune response evaluation, is convenient for operation, and is high in application value.

Description

technical field [0001] The invention relates to a method for detecting tissue cross-reaction of monoclonal antibody drugs, in particular to a method for detecting tissue cross-reaction of monoclonal antibody drugs using fresh frozen tissue. Background technique [0002] Monoclonal antibodies have the ability to specifically recognize targets, and have the advantages of precise and controllable drug effects and few side effects. As a new type of biotechnology drugs, monoclonal antibody drugs have specific immunity. In addition, the same or similar antigenic determinants exist in normal tissue cells, and monoclonal antibody drugs may bind to other tissues or cells other than non-target organs, resulting in serious side effects. Therefore, the tissue cross-reactivity of monoclonal antibody drugs is very important in the preclinical safety evaluation of drugs, and is now widely used in the fields of biology and medical research. [0003] However, in the tissue cross-reaction te...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N1/42G01N1/28G01N33/577G01N33/15
Inventor 张亮徐银妹孟丽李凤琨孙小林杨倩王茂伟王远琪
Owner WUXI APPTEC SUZHOU
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