Application of Tangential Flow Filtration in the Production Process of Hepatitis B Vaccine
Application of Tangential Flow Filtration in the Production Process of Hepatitis B Vaccine
Introduction
The invention of hepatitis B vaccine is a major achievement of vaccine research. Hepatitis B virus (HBV) infection is a worldwide epidemic. According to the World Health Organization (WHO), there are about 296 million chronic HBV infected people in the world; about 820,000 people die of HBV infection-related diseases worldwide every year. HBV infection is an important etiology and disease progression factor of HCC. 84% of liver cancer in China is caused by HBV infection. In the face of such a fierce hepatitis B virus, humans invent the hepatitis B vaccine to effectively prevent its spread. According to statistics, since the implementation of hepatitis B vaccination, the carrier rate of hepatitis B virus has been greatly reduced in both developed and developing countries.
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Hepatitis B vaccine
Hepatitis B vaccine is a special drug used to prevent hepatitis B. After vaccination, the immune system can be stimulated to produce protective antibodies, which exist in human body fluids. Once the hepatitis B virus appears, the antibodies will act immediately to remove it and prevent infection without harming the liver, thus making the human body immune to prevent hepatitis B, so as to achieve the purpose of preventing hepatitis B infection. Vaccination against hepatitis B is the most effective way to prevent hepatitis B virus infection.
Hepatitis B vaccines are divided into blood-derived hepatitis B vaccines and genetically engineered hepatitis B vaccines. Among them, genetically engineered hepatitis B vaccines are further divided into yeast hepatitis B vaccines and CHO hepatitis B vaccines. At present, genetically engineered hepatitis B vaccines are mostly used in our country, and the proportion of yeast hepatitis B vaccines in 2019 is about 97%.
3. Hepatitis B vaccine production process
The tangential flow filtration technology has the advantages of mild and low shear force, flexible operation, long service life of products, low cost, and easy scale-up, etc. It is used in biopharmaceutical such as vaccines and life science research fields. It can be seen from the production process of hepatitis B vaccine that both the production of blood-related hepatitis B vaccine and the production of genetically engineered hepatitis B vaccine are inseparable from the tangential flow filtration technology, which runs through the entire production of hepatitis B vaccine.
Blood-derived hepatitis B vaccine: blood-derived hepatitis B vaccine is made from the plasma of asymptomatic hepatitis B carriers, concentrated and purified, the effective antigen HBsAg is extracted, and the adjuvant aluminum hydroxide is added after inactivation. The successfully developed hepatitis B vaccine can prevent and control hepatitis B after being inoculated into the human body. On the basis of previous research, a comprehensive purification technology of high-titer plasma raw materials through multiple zonal ultracentrifugation, ultrafiltration combined with enzyme treatment and a three-step inactivation process of gastric enzymes, urea, and formaldehyde have been established.
Genetic engineering hepatitis B vaccine: genetic engineering hepatitis B vaccine is hepatitis B surface antigen (HBsAg) subunit vaccine, which uses modern biotechnology to construct a plasmid for the gene expressing surface antigen of hepatitis B virus, and clones it into brewer’s yeast or CHO cells, express the HBsAg subunit by culturing the recombinant yeast or CHO cells. After fermentation, cell disruption, a series of microfiltration, ultrafiltration, silica gel adsorption, elution and then hydrophobic chromatography, it can make the purity of the product antigen protein reach more than 99%.
