Preparation process of human hepatitis B immunoglobulin

Abstract

The invention discloses a preparation process of human hepatitis B immunoglobulin. The preparation process comprises the following steps: adopting plasma higher than the standard, and separating by a low-temperature ethanol method and a filter press technique to obtain sediment of components II and III; dissolving and carrying out dissolution and filter pressing to obtain refined sediment of components II and III; dissolving, adjusting reaction parameters, carrying out filter pressing, depth filtration, ultrafiltration and dialysis, and adjusting protein fluid parameters; carrying out column chromatography purification by using DEAE Sepharose Fast Flow weak anion exchange gel; carrying out ultrafiltration, and adjusting the pH to 4.05-4.15; adding maltose as a protecting agent; carrying out inactivation of low-pH inoculated viruses and virus removal by a DV20 filter element, carrying out secondary ultrafiltration, and controlling the maltose residue to be not higher than 2g / L; and then adding glycine as a protecting agent and the like, so as to prepare the specific human hepatitis B immunoglobulin of which the purity is over 99.0% and the valence is not lower than 100 IU / ml, wherein the total content of IgG monomer and dimer in the specific human hepatitis B immunoglobulin is over 98.0%. Compared with a traditional low-temperature ethanol method, the preparation process can improve the yield of human hepatitis B immunoglobulin by 7.5%-10%.

Description

technical field [0001] The invention relates to a preparation process of hepatitis B human immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] Hepatitis B immunoglobulin (HBIG) is a specific immunoglobulin prepared by separation, purification and virus inactivation from plasma with high hepatitis B surface antibody titer collected by hepatitis B vaccine immune health donors , has specific passive immunity, can neutralize the surface antigen in the body and clear the virus. [0003] Clinically, human hepatitis B immunoglobulin can play important functions in the following aspects: 1. Block vertical mother-to-child transmission of hepatitis B. Hepatitis B virus can be transmitted vertically from mother to baby to infect newborns. Most babies are infected by inhaling maternal blood, amniotic fluid or vaginal secretions during delivery. Once a baby is infected with hepatitis B virus, 80-90% will become a chronic carrier. Therefore, ...

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Problems solved by technology

After 2 days, although the comprehension is normal, the speech becomes slow and slurred

In recent years, although many monoclonal antibodies and genetically engineered antibodies, including humanized antibodies and small molecule antibodies, have been developed, because genetically engineered antibodies are a newly developed technology, they are now only used for clinical diagnosis and tumor treatment. Treatment, how effective this antibody is, needs to be confirmed in practice

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