Process for preparing rabies human immune globulin

An immunoglobulin and preparation technology, which is applied in the field of biopharmaceuticals, can solve the problems of rabies immunoglobulin shortage, low yield of immunoglobulin, and many separation steps, etc., and achieve clear pharmacological effects, mature technology, and safety sex high effect

Active Publication Date: 2014-12-10
华润博雅生物制药集团股份有限公司
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Problems solved by technology

Therefore, it is very necessary for the preparation of rabies patient immunoglobulin, the special drug for treating rabies, and as far as the production technology of anti-rabies patient immunoglobulin is concerned, the p

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  • Process for preparing rabies human immune globulin
  • Process for preparing rabies human immune globulin
  • Process for preparing rabies human immune globulin

Examples

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Embodiment 1

[0041] Embodiment 1: Taking 5000 liters of plasma as an example, the specific preparation process is as follows:

[0042] (1) Centrifuge 5,000 liters of human plasma that has passed the quarantine period, and control the temperature of the centrifuged liquid at 0-4°C; separate the cryoprecipitate, use the cryoprecipitate for the production of factor VIII, and transport the supernatant to the protein separation reaction tank , control the temperature of the protein solution between 1 and 3°C, slowly add pH 4.0 acetate buffer to adjust the pH to 6.70 to 7.20; add 95% or 50% ethanol below -15°C to make the final concentration of ethanol to 8 % (V / V), the temperature is controlled at -1~-3°C, and the pH value after adding ethanol should be 6.80~7.20; the pH4.0 acetic acid buffer is an aqueous solution composed of sodium acetate and glacial acetic acid. Add 244.9mL mass concentration of 99% glacial acetic acid and 65.6g sodium acetate.

[0043] (2) Stir the product obtained in ste...

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Abstract

The invention discloses a process for preparing rabies human immune globulin. According to the process, immune globulin is extracted and separated by using a low-temperature ethanol filter press technique, a chromatography method, an ultrafiltration method, a nano filtering method, a secondary ultrafiltration method and a washing, baking and filling linked sub-packaging process technique. The process is characterized in that a one-step ion exchange chromatography method is adopted as the chromatography method, the component III supernate is firstly refined before chromatography, then the premasters of the refined component III supernate are adjusted so that the protein concentration of the refined component III supernate is 3-6%, the pH value of the refined component III supernate is 6.4-6.6, and the conductivity is 0.18-0.22s/m when the temperature is 19 DEG C, after the adjustment, column chromatography purification is performed by using an ion exchange column, DEAESepharoseFF packing is adopted in chromatography, and the pH value is adjusted to be 3.8-4.0 after chromatography is completed. Compared with a conventional process, the process has the advantages that the yield is increased by 19.2-25%, small dosage is needed, and the use of human immune globulin is reduced, so that the scarce plasma resource is saved.

Description

technical field [0001] The invention relates to a preparation process of rabies patient immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] Rabies is an elastic virus whose pathogen is ribonucleic acid. According to the statistics of the World Health Organization, more than two-thirds of the countries and regions in the country have rabies epidemics. my country and Southeast Asia are in the world's high incidence of rabies, and its cases account for more than 70% of the world. However, once the onset of rabies, there is currently no cure, and the mortality rate is almost 100%. If a sufficient amount of rabies patient's immunoglobulin can be provided in time, so that the antibody in the patient's serum can reach above 0.5IU / ml, the patient can be effectively protected. Therefore, it is very necessary for the preparation of rabies patient immunoglobulin, the special drug for treating rabies, and as far as the production technology of...

Claims

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Application Information

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IPC IPC(8): C07K16/06C07K1/36C07K1/34C07K1/18
Inventor 梁小明饶振何淑琴阮景文匡青芬
Owner 华润博雅生物制药集团股份有限公司
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