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A kind of preparation method of radionuclide 131i-monoclonal antibody marker

A monoclonal antibody and marker technology, used in radioactive carriers, drug combinations, anti-tumor drugs, etc.

Active Publication Date: 2016-06-22
SHANGHAI HAIKANG PHARMA TECH & DEVE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although researchers have done a lot of research on optimizing parameters such as the amount of iodide used in conventional labeling methods, or antibody concentration, reaction time, and the ratio of radionuclides and antibodies, no researcher has reported the preparation of high-immune binding activity. Labeled products require arginine buffer pretreatment of antibodies

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  • A kind of preparation method of radionuclide 131i-monoclonal antibody marker
  • A kind of preparation method of radionuclide 131i-monoclonal antibody marker
  • A kind of preparation method of radionuclide 131i-monoclonal antibody marker

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preparation example Construction

[0022] The present invention involves the preparation of radionuclides with high radioactivity specificity, high radiochemical purity and high immunological binding activity 131 I-The new method of monoclonal antibody labeling, according to the description of this manual, it is easy to prepare a variety of radionuclides 131 I- Monoclonal antibody labeling is achieved during the process.

[0023] The following will take NBS as an example to describe the implementation of the present invention in detail. On the basis of the conventional NBS method, a key pretreatment is performed on the monoclonal antibody to be labeled before adding the NBS reaction, so that for some basic monoclonal antibodies produced by eukaryotic mammalian cell expression The immunological binding activity of the labeled product is greatly improved compared with the conventional NBS labeling method, so as to meet the requirements of the further use of the labeled product in clinical diagnosis and treatment...

Embodiment 1

[0036] Example 1 Large-scale preparation of radionuclides of 3 monoclonal antibodies by conventional NBS method 131 I-Monoclonal antibody markers and assay of immunobinding activity of labeled products

[0037] Large-scale preparation of radionuclides by conventional NBS method 131 I- monoclonal antibody marker, optimized, the specific operation steps are:

[0038] 1. Under sterile conditions before labeling: Add 0.4ml of 0.1MpH7.4 phosphate buffer solution to 5mg (1ml) of monoclonal antibody, mix well; dissolve 2.0ml with 0.1MpH7.4 phosphate buffer solution 1.0ml mg of NBS; equilibrate the PD-10 desalting purification column (GE Company) with 25ml of 0.01M pH7.2 phosphate buffer solution; add 0.1ml of 20% human serum albumin pre-saturated PD to the PD-10 purification column after equilibrium -10 purification columns.

[0039] 2. Under aseptic conditions during labeling: take about 3.7GBq of Na131I solution (volume not exceeding 1.0ml, quality in line with medical sta...

Embodiment 2

[0041] Example 2 Using arginine buffer pretreatment method combined with conventional NBS method to prepare three kinds of radionuclides of monoclonal antibodies on a large scale 131 I-Monoclonal antibody markers and assay of immunobinding activity of labeled products

[0042] Large-scale preparation of radionuclides by conventional NBS method 131 I- monoclonal antibody marker, optimized, the specific operation steps are:

[0043] 1. Under sterile conditions before labeling: use 25ml of buffer solution containing 0.4M arginine 50mMNaClpH3.8 to pre-equilibrate PD-10 desalting purification column (GE company), and 2.5ml of antibody solution of about 38.6mg / ml Add PD-10 desalting purification column, after the antibody solution completely enters the column surface, use buffer solution containing 0.4M arginine 50mMNaClpH3.8 as the eluent, collect the first 3ml eluent; place at 4 degrees Celsius for 2-4 hours ; Use 25ml of buffer solution containing 0.4M arginine 50mMNaClpH...

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Abstract

The invention relates to a preparation method of a radioactive nuclide <131>I-monoclonal antibody marker, and a use of the radioactive nuclide <131>I-monoclonal antibody marker obtained through the method in the preparation of products used for diagnosing and / or treating tumors. The method is characterized in that a monoclonal antibody is preprocessed by an arginine buffer solution before the monoclonal antibody is marked, and then a routine marking method is combined. The radioactive nuclide <131>I-monoclonal antibody marker obtained through the method has the advantages of high specific radioactivity, high radioactive chemical purity and high immune binding activity.

Description

technical field [0001] The present invention relates to a radionuclide 131 I-Method for preparing monoclonal antibody marker, and radionuclide obtained by this method 131 I-Use of a monoclonal antibody marker in the preparation of a product for diagnosing and / or treating tumors. Background technique [0002] Because of its good specificity and strong binding ability, anti-tumor monoclonal antibodies can be used in radioimmunoguided therapy as a carrier to carry radionuclides that play a role in killing, and effectively carry radionuclides labeled with antibody molecules in patients. To the local tumor, kill the tumor, play an important role in the treatment of tumors. At present, there are a variety of specific anti-tumor monoclonal antibodies for us to choose from, including anti-CD20 antibody, anti-carcinoembryonic antigen (CEA) antibody, anti-epidermal growth factor receptor family member 2 (HER2) antibody, etc. The most commonly used radioactive isotopes are 3 H. 14...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K51/10A61P35/00A61K101/02
Inventor 杨治华冉宇靓周薇于山
Owner SHANGHAI HAIKANG PHARMA TECH & DEVE