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A continuous preparation method of antibody (or antigen) coated microspheres

A technology of microspheres and antibodies, applied in the preparation of microspheres, microcapsule preparations, instruments, etc., can solve the problem of no antibody reported in the literature, and achieve the effects of controllable product quality, mild reaction conditions and good contact.

Active Publication Date: 2021-10-26
苏州英诺凯生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] So far, no literature has reported the process of using microchannel continuous flow to achieve antibody or antigen-coated microspheres

Method used

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  • A continuous preparation method of antibody (or antigen) coated microspheres
  • A continuous preparation method of antibody (or antigen) coated microspheres

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] refer to figure 1 The industrial process of the present invention follows the following steps: (1) First, the Buffer A solution of the microspheres in S1 and the Buffer A solution of the condensing agent pass through the P1 and P2 metering pumps, and are mixed into the mixing module M1 according to a certain ratio ; (2) After the reaction in R1, it passes through the filter module F1 to remove impurities, (3) Then the buffer B1 is pumped into the module M2 through the metering pump, and mixed with the activated microspheres, (4) The B1 solution of the antibody is passed through The metering pump enters the mixing module M3 to mix with the activated microspheres, and then reacts in the reaction module R2, (5) then passes through the filtration module F2 to remove excess antibodies and impurities, (6) the effluent is mixed with the buffer in the mixing module M4 B2 is mixed, and the mixed solution is finally collected in the collection module C. This example describes a...

Embodiment 2

[0042] refer to figure 2 The industrial process of the present invention follows the following steps: (1) First, the Buffer A solution of the microspheres in S1 and the Buffer A solution of the antibody (or antigen) pass through the P1 and P2 metering pumps, and are injected into the mixing module according to a certain ratio M1 is mixed; (2) After the reaction in R1, it passes through the filter module F1 to remove impurities, (3) The effluent is mixed with buffer B2 in the mixing module M4, and the mixed solution is finally collected in the collection module C. This example describes the general physisorption method for coating microspheres.

Embodiment 3

[0044] (1) The device used: refer tofigure 1 Determine the connection mode of the microchannel reactor, the number of mixed reaction modules is determined according to the flow rate and reaction residence time, and the heat exchange medium is ethanol.

[0045] (2) In a microchannel reactor with a diameter of 200 µm, a buffer solution (15 mg / mL, flow rate 1 mL / min) of polystyrene microspheres (200 nm) with carboxyl groups on the surface and a buffer solvent of condensing agent EDC (5 mg / mL mL, flow rate 1mL / min) mixed in the mixing unit M1 (temperature 25 degrees), stay in R1 for 300 seconds (temperature 25 degrees), and then pass into the filter unit F1 (temperature 25 degrees), the residence time is 120 seconds, and then in the module M2 was mixed with buffer B1 (1 mL / min). Afterwards, the B1 solution of NGAL antibody (5mg / mL, 1mL / min) was pumped into the mixing module M3 through the metering pump to mix with the activated microspheres, and then stayed in the reaction module...

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Abstract

The invention provides a production process for preparing antibody-coated microspheres in a high-throughput microchannel continuous flow reactor. The invention uses a microchannel reactor to prepare antibody-coated microspheres, which is suitable for the process of coating various macromolecules on the surface of various particles, including physical adsorption coating and chemical coupling coating reactions. Both methods can be carried out according to corresponding steps, and modules can be reduced or new functional modules can be added according to specific process requirements. Compared with the existing technology, the preparation method provided by the invention has the characteristics of precise control of reaction conditions, high utilization rate of raw materials, controllable product quality, simple operation, etc., and can produce antibody-coated microspheres safely, environmentally friendly and efficiently.

Description

technical field [0001] The invention belongs to the field of research and development and production technology of biomedicine, and specifically relates to the coating process of latex or magnetic microspheres (magnetic beads) with antibodies (or antigens) or other proteins in the production technology of in vitro diagnostic reagents, and more specifically relates to the coating process of antibodies (or antigens) or other proteins at high The process of coating various latex microspheres, magnetic beads, or metal nanoparticles with different antibodies, antigens, or other macromolecules in a continuous-flow microchannel reactor. Background technique [0002] Immunodiagnostics are a common form of in vitro diagnostics. Its essence is to quantitatively or qualitatively analyze the content of antigen or antibody in the test sample by using the specific combination of antibody and antigen in the immune reaction, so as to make a clinical diagnosis. Many common immunodiagnostic ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B01J13/02G01N33/543G01N33/531
Inventor 刘向晖黄迎庆陈胜胜王文龙
Owner 苏州英诺凯生物医药科技有限公司