Method for preparing tetanus human immune globulin by double virus inactivation

A technology of human immunoglobulin and immunoglobulin, applied in the direction of anti-bacterial immunoglobulin, immunoglobulin from serum, peptide preparation method, etc., can solve the problems affecting the ability to remove viruses, and achieve the effect of reducing diseases

Inactive Publication Date: 2012-07-25
新疆德源生物工程有限公司
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  • Abstract
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  • Application Information

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Problems solved by technology

According to the requirements of the "Technical Methods and Verification Guidelines for Blood Products Removal/Ina

Method used

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  • Method for preparing tetanus human immune globulin by double virus inactivation
  • Method for preparing tetanus human immune globulin by double virus inactivation
  • Method for preparing tetanus human immune globulin by double virus inactivation

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Embodiment 1

[0025] This strain is separated from healthy human plasma containing high titer tetanus antibody, separated and purified by low-temperature ethanol protein separation method, and used pH4.0, 23~25℃21 days incubation inactivated virus and DV50 nanomembrane in addition to virus membrane. Virus inactivation production process system. It is mainly used to prevent and treat tetanus, especially for those who have allergic reactions to tetanus antitoxin (TAT).

[0026] 1. Plasma pooling

[0027] Take out qualified raw plasma for more than 100 people, and melt it after cleaning and disinfection. The melted plasma is combined in the reaction tank, and the plasma in the reaction tank is measured. The plasma in the reaction tank is evenly stirred and then sampled for testing of total protein content, albumin purity and tetanus antibody.

[0028] 2. Component I+II+III(F I+II+III )

[0029] 2.1. Component I (F I )

[0030] The plasma was diluted with 0.14mol / L NaCl solution, diluted and mixed. A...

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Abstract

The invention discloses a method for preparing tetanus human immune globulin by double virus inactivation. The method comprises separating and purifying blood plasma from healthy people containing high-potency tetanus antibody by a low-temperature ethanol protein-separating method, and inactivating virus at the pH value of 4.0 after incubation at 23-25 DEG C for 21 days and treating with DV50 nanometer anti-virus membrane for double virus inactivation. The method of the invention has the beneficial effects that the tetanus human immune globulin prepared by double virus inactivation can greatly reduce disease transmitted by blood products, and the quality of products fully complies with the requirement of Pharmacopoeia of People's Republic of China. Through a test using the pseudorabies virus, Sindbis virus and human immunodeficiency virus (HIV), the virus titer (TCID50) can be decreased by at least 4.00log. The safety and reliability of the products are ensured. The tetanus human immune globulin is particularly suitable for people allergic to tetanus antitoxin (TAT).

Description

Technical field [0001] The invention relates to a method for preparing biological products, in particular to a method for preparing tetanus human immunoglobulin by inactivating double viruses. Background technique [0002] Tetanus human immunoglobulin is a blood product. As blood products are widely used clinically, how to ensure the safety of blood products, prevent and control blood-borne diseases has become a common concern in the world medical and health circles and the entire society. focus. At present, although there have been units that use double virus inactivation to prepare tetanus human immunoglobulin, they do not have specific parameters in the inactivation process, such as the concentration, filtration rate, pressure and filtration volume of the protein solution in the virus removal process of the DV50 nanomembrane. , The integrity of the filter membrane before and after filtration and the pH value, protein concentration, sugar content, incubation time and temperatu...

Claims

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Application Information

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IPC IPC(8): C07K16/12C07K16/06C07K1/16A61K39/40A61P31/04
Inventor 吕献忠孔冬冬
Owner 新疆德源生物工程有限公司
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