Study On Production Process Of Herpes Zoster Vaccine

Herpes zoster(HZ)is an acute,inflammatory,viral skin disease caused by the varicella-zoster virus which mainly happens in spring and autumn.Herpes zoster distributes along sensory ganglia and is often accompanied by neuralgia.Herpes zoster has its own limitation.Herpes zoster virus can cause sequelae neuralgia,which seriously impacts on patients,and ultimately lead to a significant decline in the quality of life of patients.According to relevant reports,about 50% of people with herpes zoster are over 60 years old,while more than half of people over 85 years old may have herpes zoster.Relevant data have confirmed that injecting live attenuated vaccine of herpes zoster can reduce the incidence of herpes zoster,and reduce the incidence of PHN after the attack.It can also alleviate the symptoms of herpes zoster,reduce the severity of symptoms,alleviate the suffering of the elderly and improve the quality of life.And herpes zoster cure process is long or expensive.Prevention of herpes zoster can reduce the economic burden.China have entered the elderly society.Herpes zoster will bring great inconvenience and economic burden to the elderly.It is of great social significance for the state to promote herpes zoster vaccine.At present,there are two foreign pharmaceutical companies producing herpes zoster vaccine to prevent herpes zoster and post-herpes zoster neuralgia.Since herpes zoster vaccine is injected into adults,it is required that the single dose of the vaccine should be at a high level to stimulate the production of antibodies,so the production process of herpes zoster must have high-yield characteristics.At present,the production and research of herpes zoster vaccine in domestic and foreign enterprises are limited by low production and can not be produced on a large scale.The annual output of foreign listed enterprises is relatively low,so it is necessary to study the production research of herpes zoster vaccine.The process of herpes zoster vaccine is long,which includes cell resuscitation,cellsubculture,virus culture,washing and liquid exchange,single harvest preparation,raw liquid preparation,semi-finished product preparation and finished product preparation.There are many technological parameters in each process.Influencing factors of cell culture link(cell passage ratio),virus culture link(culture temperature,culture medium type,serum concentration,sodium bicarbonate concentration,glutamine concentration,multiple MOI of infection,virus inoculation method,etc.)and virus harvest link(washing strip)were discussed from the aspects of cell factory technology.Comparisons were made on parts,centrifugal speed,centrifugal time and storage time.By observing cell morphology,counting cells,detecting virus titer,detecting kanamycin residue and bovine serum albumin residue,the preparation process of herpes zoster vaccine was determined.The results showed that the cell density and morphology were affected by different proportions of cell passage.When the cell passage ratio was 1:2,the cell density was higher and the cell morphology was better.When the concentration of serum,sodium bicarbonate and glutamine was 2%,2% and 5% respectively,the culture temperature was35 ?,the culture medium was MEM in Nissui water,the MOI is in the range of0.01-0.1%,and prepared by mixed inoculation,the titer of virus was higher,lower in the single harvest of kanamycin residue and bovine serum albumin residue prepared by 400ml/layer detergent,higher in the single harvest by centrifugation at 1500 rpm speed for 15 minutes,and higher in the single harvest.The obtained product was kept in a freezer below-60 ? for 12 months,and the titer was stable.The production of herpes zoster vaccine was increased several times by optimizing the process parameters,and the content of antibiotics and bovine serum albumin was reduced,and the quality was safer.