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Kit for radionuclide labeled antibody and application thereof

A radionuclide and labeled antibody technology, applied in the direction of radioactive carriers, peptides, specific peptides, etc., can solve the problems of unstable yield, long time consumption, and high requirements for storage conditions, and achieve high in vitro stability and technological conditions. Stable, high-resolution images

Inactive Publication Date: 2019-04-02
NANJING PET TRACER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1. Different raw materials need to be purchased from different suppliers, and the raw materials are subpackaged and prepared on site, which takes a long time and the supply of raw materials is unstable;
[0006] 2. The half-life of some radionuclides is short, the synthesis and purification must be fast and effective, and the requirements for storage conditions during transportation are also high
[0007] 3. The accuracy of the ratio is difficult to grasp, the yield is unstable, and the product quality is unstable

Method used

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  • Kit for radionuclide labeled antibody and application thereof
  • Kit for radionuclide labeled antibody and application thereof
  • Kit for radionuclide labeled antibody and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1) Preparation of labeled precursor

[0036] Take the NaHCO whose concentration is 0.1mol / L pH=8.4 3 solution to dilute the aqueous solution of antibody KN035 so that the concentration of KN035 is 10mg / mL, and then use 0.1mol / L Na 2 CO 3 Adjust the pH of the solution to 9.0; then add a DMSO solution of the chelating agent Df-Bz-NCS at a concentration of 2 mol / mL, so that the molar ratio of Df-Bz-NCS to KN035 is 5:1, after mixing, at 37 ° C After reacting for 60 minutes, the crude product of the labeled precursor Df-Bz-NCS-KN035 was obtained.

[0037] The obtained crude product was purified by a PD10 column eluting with sodium acetate, and was used after purification.

[0038] 2) Kit composition

[0039] a. The first vial: containing Df-Bz-NCS-KN035 3mg

[0040] b. The second vial: 5ml of acetic acid-sodium acetate buffer solution with pH=6.5

[0041] c. The third vial: containing 1ml of sodium carbonate solution

[0042] d. Fourth vial: 50ml of acetic acid-sodium...

Embodiment 2

[0062] 1) Preparation of labeled precursor

[0063] In phosphate buffered saline (PBS), the molar ratio of the chelating agent DOTAGA to the antibody Denosumab was 10:1, and reacted at 37°C for 2 hours to obtain the crude product of the labeled precursor Denosumab-DOTAGA.

[0064] The obtained crude product was purified by using a PD10 column eluted with physiological saline, and was used after purification.

[0065] 2) Composition of the kit

[0066] a. The first vial: containing Denosumab-DOTAGA 1mg

[0067] b. The second vial: 3ml of sodium acetate buffer containing pH=5.0

[0068] c. The third vial: containing 1ml of sodium bicarbonate solution

[0069] d. The fourth vial: containing 50ml of physiological saline buffer

[0070] It also includes 1 Hitrap Desalting desalting column, 1 sterile filter membrane, 4 syringes, and instructions for use.

[0071] 3) Use of the kit

[0072] a. Add 5mCi 64 The Cu solution was injected into the acetic acid-sodium acetate buffer ...

Embodiment 3

[0079] 1) Preparation of labeled precursor

[0080] Take the NaHCO whose concentration is 0.1mol / L pH=8.4 3 The solution dissolves the antibody Ipilimumab, so that the concentration of Ipilimumab is 10mg / mL, and then 0.1mol / L Na 2 CO 3 Adjust the pH of the solution to 9.0; then add a DMSO solution of the chelating agent Df-Bz-NCS at a concentration of 2mol / mL to it, so that the molar ratio of Df-Bz-NCS to Ipilimumab is 5:1, after mixing, at 37°C After reacting for 60 minutes, the crude product of the labeled precursor Df-Bz-NCS-Ipilimumab was obtained.

[0081] The obtained crude product was purified by a PD10 column eluting with sodium acetate, and was used after purification.

[0082] 2) Composition of the kit

[0083] a. The first vial: containing Df-Bz-NCS-Ipilimumab 2mg

[0084] b. The second vial: 5ml of sodium citrate buffer containing pH=7.0

[0085] c. The third vial: containing 1ml of sodium carbonate solution

[0086] d. The fourth vial: containing sodium cit...

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Abstract

The invention relates to a kit for radionuclide labeled antibody and an application thereof, which belong to the technical fields of radiopharmaceuticals and nuclear medicine. The kit comprises a first vial containing the antibody-chelating functionalized molecules, a second vial containing a buffer solution, a third vial containing a pH adjusting agent, a fourth vial containing a solvent, a purification column, an aseptic filter membrane, a syringe, and an usage specification. A method of using the kit is further disclosed. The kit of the invention is convenient to operate, has a high labeling rate, and the prepared radionuclide-labeled antibody drug has good stability in vitro and in vivo; the distribution and metabolism of drugs in animals can be objectively and accurately observed through PET-CT imaging, the specificity is strong, accurate diagnosis can be achieved, and the kit is expected to be popularized and applied in clinic.

Description

technical field [0001] The invention belongs to the technical field of radiolabeling, and in particular relates to a radionuclide-labeled antibody drug, a kit and application thereof. Background technique [0002] Positron emission computed tomography (PET) uses positron radioactive nuclides to label some physiologically required compounds or metabolic substrates such as glucose, fatty acids, amino acids, receptor ligands, and water. In vivo chemical imaging technology obtained by scanning machine. It has received extensive clinical attention for its ability to display the metabolic activity of organs or tissues and the function and distribution of receptors, also known as "in vivo biochemical imaging". It can be said that the emergence of PET has brought medical imaging technology to a new level, enabling non-invasive, dynamic and quantitative evaluation of the physiological and biochemical changes of cell metabolism in living tissues or organs under physiological conditio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K51/10A61K103/00
CPCA61K51/10C07K16/00
Inventor 王正李世红罗志刚蔡飞戴娟徐建锋
Owner NANJING PET TRACER
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