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Method for purifying immunoglobulin

A technology of immunoglobulin and cation exchange, which is applied in the direction of immunoglobulin and peptide preparation methods, chemical instruments and methods, etc., which can solve the problems of immunoglobulin pain, reduce the activity of immunoglobulin antibody, complex production, etc.

Active Publication Date: 2017-02-15
KOREA GREEN CROSS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, immunoglobulins for intramuscular injection have the following problems: 1) the dose of such immunoglobulins is limited, making it impossible to administer immunoglobulins in large quantities; 2) immunoglobulins cause pain; 3) low levels of native immunoglobulin G (IgG) with antibody activity in the immunoglobulin; 4) proteases at the site of injection reduce the antibody activity of the immunoglobulin; and 5) the time to peak plasma concentration is 24 hours or more
However, the problem with this method is that it is more complicated and the yield is lower

Method used

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  • Method for purifying immunoglobulin
  • Method for purifying immunoglobulin
  • Method for purifying immunoglobulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1: Preparation of intravenous immunoglobulin

[0077] 1-1: Preparation of plasma

[0078] For plasma, use FDA-approved plasma with bioassays that include nucleic acid amplification for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and parvovirus B19 testing and serological testing.

[0079] In the present invention, plasma derived from the United States (Lot No. 600B0491) was used. Plasma was stored at -20°C or below until use. The vials containing the plasma were opened with a bottle cutter and the plasma was thawed by incubation at 1-6°C for 12-72 hours in a jacketed vessel.

[0080] When plasma is thawed under the above conditions, cryopreserves containing fibrinogen and coagulation factors are produced. The resulting condensed protein was removed by centrifugation and the remaining cryolabile plasma was recovered.

[0081] 1-2: Precipitation Ⅰ

[0082] Add 96% ethanol to the cold-labile plasma recovered in ...

Embodiment 2

[0113] Example 2: Measurement of thrombin / IgG (thromboembolic risk) produced in immunoglobulin solutions at each preparation step risk)

[0114] The purity (thrombin / IgG) of the immunoglobulin preparation sampled in each preparation step of Example 1 was measured.

[0115] 2-1: Experimental method

[0116] In the present invention, according to the Thrombin Generation scheme (CBER Thrombin Generation protocol 01Experiment (100916)a) provided by CBER (Center for Biological Products Evaluation and Research), one of FDA's six affiliated analytical institutions, implement the immunization in each step of Example 1 Measurement of thromboembolic risk of globulin solutions.

[0117] 2-2: Experimental results

[0118] The immunoglobulin purification process according to the present invention includes Cohn's plasma fractionation method and ion exchange chromatography purification technology. as below figure 2 As shown in Table 1, it can be seen that the octanoate precipita...

Embodiment 3

[0122] Example 3: Measuring the concentration of FXI (human coagulation factor XI) in the filtrate or precipitate at each preparation step

[0123] In order to detect the degree of coagulant removal, the filtrate and precipitate sampled in each preparation step of Example 1 were measured by ELISA (AssayMax Human Factor XI(FXI) ELISAKit; ssaypro, Cat. No. EF1011-1) and SDS-PAGE. Concentration of FXI (human coagulation factor XI).

[0124] Table 2: FXI Content of Purification Process Products

[0125]

[0126] The FXI content of the product of the purification process according to the invention can be measured by ELISA and SDS-PAGE. Therefore, as in Table 2 above and image 3 As shown, FXI was almost removed in zincate precipitation, cation exchange chromatography and anion exchange chromatography.

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Abstract

The present invention relates to a method for purifying immunoglobulin, more specifically to a method for purifying immunoglobulin characterized by dissolving plasma protein fractions I+II+III or fractions II+III containing immunoglobulin, adding caprylate to induce precipitation, and then concentrating via dialysis, efficiently discarding the solvent and cleansing agent, which are added when viruses are inactivated, by means of anion exchange resin and ceramic cation exchange resin purification methods, and maintaining a low polymer content by maintaining a set saline concentration during elution. The method for purifying immunoglobulin for intravenous injection according to the present invention allows the precipitation step for producing fraction II to be omitted as fractions I+II+III or fractions II+III are starting materials, solves the issues of burdensome nature of the process and low yield associated with a production using a polyethylene glycol treatment by employing a sodium caprylate primary precipitation method, anion exchange chromatography and cation exchange chromatography. Furthermore, when the method for purifying immunoglobulin according to the present invention is used, impurities and products of thrombosis are removed with greater efficiency, and the polymer content can be maintained, thereby allowing immunoglobulin having a stable and enhanced quality to be produced.

Description

technical field [0001] The present invention relates to a method for purifying immunoglobulin, and more particularly, relates to a method for purifying immunoglobulin comprising: dissolving immunoglobulin-containing plasma protein fraction (fraction) I+II+III or fraction II +III, followed by precipitation by addition of caprylate, dialysis and concentration, followed by anion exchange resin and ceramic cation exchange resin purification processes to effectively remove added solvents and detergents for virus inactivation, and Keep the salt concentration at a constant level to keep the polymer content of the immunoglobulin at a low level. Background technique [0002] Immunoglobulins are plasma proteins that contain antibodies against various viruses and bacteria and are used prophylactically or therapeutically by administering them to subjects who naturally lack antibodies or to patients who require artificial supplementation of antibodies due to viral or bacterial diseases ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K1/36C07K1/18C07K1/30C07K1/34C07K16/00
CPCC07K1/36C07K16/065C07K1/18C07K1/30C07K1/34
Inventor 朴东焕孙基桓徐康润崔圣民李建术金基镕
Owner KOREA GREEN CROSS CORP
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