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Cryoprotectant and lyophilization method for latex coupled antibody

A technology of latex-conjugated antibody and freeze-drying protective agent, which is applied in the field of medicine, can solve the problems of poor aggregation state and less modified latex antibody, and achieve good freeze-drying protection effect

Active Publication Date: 2016-06-29
SHENZHEN GOLDSITE DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, due to problems such as poor aggregation state after reconstitution, freeze-drying technology is rarely applied to latex-modified antibodies

Method used

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  • Cryoprotectant and lyophilization method for latex coupled antibody
  • Cryoprotectant and lyophilization method for latex coupled antibody
  • Cryoprotectant and lyophilization method for latex coupled antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0047]For the C-reactive protein latex antibody coupling solution, this time, a rabbit anti-human C-reactive protein latex antibody solution with a mass fraction of 0.2% was used. Add the lyoprotectant according to the scheme in Table 1 and implement the lyophilization scheme:

[0048] Table 1 Examples 1-6

[0049]

[0050] Wherein, freeze-drying procedure 1 is:

[0051]

[0052] Freeze-drying procedure 2 is:

[0053]

[0054] Freeze-drying procedure 3 is:

[0055]

[0056] Freeze-drying procedure 4 is:

[0057]

[0058] Each example was repeated 5 times, and the reconstituted appearance and antibody titer of the freeze-dried samples were tested, and the blank value was identified by immunoturbidimetry; meanwhile, the repeatability among the repetitions of each example was calculated.

[0059] Immunoturbidimetric blank value detection method: after the lyophilized product is reconstituted with distilled water, according to the National Competition-specific p...

Embodiment 7～12

[0070] A 0.4% mouse anti-human D-dimer latex antibody solution was used. Add the lyoprotectant according to the scheme in Table 2 and implement the lyophilization scheme, and the drying control procedures 1 to 4 are the same as those in Examples 1 to 6:

[0071] Table 3 Examples 7-12

[0072]

[0073] Each example was repeated 5 times, and the reconstituted appearance and antibody titer of the freeze-dried samples were tested, and the blank value was identified by immunoturbidimetry; meanwhile, the repeatability among the repetitions of each example was calculated.

[0074] The detection method of immunoturbidimetric blank value, antibody titer detection method and freeze-dried product repeatability detection method are also the same as those described in Examples 1-6.

[0075] The results are shown in Table 4:

[0076] Table 4 Test results

[0077]

[0078] As in Table 4: In terms of blank values:

[0079] Paired analysis of the detection blank value of the control ...

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Abstract

The invention relates to the technical field of medicine, in particular to a cryoprotectant and a lyophilization method for a latex coupled antibody. The cryoprotectant comprises BSA (bovine serum albumin), PEG (polyethylene glycol) and PVP (polyvinylpyrrolidone). The cryoprotectant is designed for the latex coupled antibody and can protect the activity of the latex coupled antibody from being damaged in a lyophilization process in combination with the provided lyophilization method, non-specific aggregation in a redissolution process after lyophilization cannot happen, and the antibody titer keeps stable after redissolution. Repeated experiments prove that the deviation is not obvious, the relative deviation is plus or minus 10% or smaller, and the cryoprotectant has good lyophilization protection effect.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a freeze-drying method of a freeze-drying protective agent and a latex-coupled antibody. Background technique [0002] Antibody (Ab) is an important effector molecule that mediates humoral immunity. It is a glycoprotein produced by B cells that proliferate and differentiate into plasma cells after receiving antigen stimulation. In addition to being widely used in in vitro diagnosis, antibodies are increasingly used in in vivo diagnosis and treatment of various diseases. At present, the use of antibodies to diagnose diseases is mainly done through the detection of markers. The detection methods of markers mainly include immunofluorescence, immunoturbidimetry, enzyme-linked immunosorbent assay, and immunodiafiltration. After coupling the antibody to latex microspheres or latex particles, a small amount of antigen can cause obvious aggregation of the antibody-coated microspheres....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K47/32A61K47/34A61K9/19A61K39/44
CPCA61K9/19A61K39/44A61K47/10A61K47/32A61K47/42
Inventor 余嘉陵陈明峰郑筱雯
Owner SHENZHEN GOLDSITE DIAGNOSTICS
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