Study On The Preparation Of Inactivated Hepatitis A Vaccine By Cultivation Of Vero Cells

Hepatitis A is a infectious viral disease of all the disease.One highly contagious, very dangerous virus is a threat to everybody, especially children. Hepatitis A is an inflammation of the liver and can leave people bedridden for weeks. Hepatitis A is a milder form of the hepatitis diseases, but it spreads very quickly, especially with pre-school-aged children. Today the only effective way to prevent the spread of the disease is the inoculation of Hepatitis A vaccine.Vero cell line is recommended by WHO for the production of human-used vaccine, so, we cultured Vero cells and were inoculated with HAV strains. The harvested virus was purified and inactivated by formaldehyde.Process development and scale-up have resulted in a well-characterized vaccine manufacturing process with appropriate in-process controls to assure consistent performance:BL-08 Hepatitis A work seed virus→triton cell lysis for virus harvest→monolayer Vero cells→production cells (inculation and maintenance at 35)→harvested Virus Culture Fluids→purification→extract by chloroform→purification by DEAE Sepharose FF anion exchange chromato bar→filtration sterilization→deactivation(3 days 1:4000 formalin)→purification by DEAE Sepharose 4FF anion exchange chromato bar→filtration sterilization→prepare half-finished product→examine the product. Results are presented from a series of manufacturing demonstration lots to show consistency, as well as product make by this way accord with the manufacture and vertification regulation.The manufacturing process from cell culture to preparation of preparation of formulated bulk is well defined and use a state-of-the-art biotechnology approach. Optimization and validation experiments carried out during development define the operating of the manufacturing process, this process ensure that the hepatitis A virus vaccine product is highly purified ,well-defined, and vell-controlled.