1、 Adopt the international advanced technology of antigen concentration and purification by ultrafiltration

The ultrafiltration and concentration equipment of Pall company in the United States is adopted for concentration, and the circulation pump of Alfa process company is equipped. According to the different production of each batch, single core and five core filter elements are equipped. Through the low temperature high-speed centrifugation of the original solution for secondary purification, and the use of different pore size closure membrane, so that the liquid and small molecules through, and the target virus is purified ultrafiltration centrifugation concentration technology.

2、 Domestic unique cobalt 60 Technology

The raw and auxiliary materials of vaccine are irradiated by cobalt-60 technology to ensure the purity of raw and auxiliary materials, which is the first technology adopted in China.

3、 Suspension culture technology

Suspension culture technology increases the number of effective working cells, adopts fully closed and pipeline system to reduce the chance of polluting cells, improves the degree of automation, uses bio-reactor for precise adjustment, reduces human operation factors, expands the volume of bio-reactor, improves the homogeneity of terminal products, increases the safety of products, and reduces the risk caused by vaccination At the same time, the immune effect of vaccine is better than that of traditional technology products.

4、 Heat resistant protective agent

The freeze-drying method of heat-resistant protective agent for freeze-dried vaccine can not only overcome the influence of temperature on titer during transportation, but also can be stored at 2-8 ℃.

5、 Filter aid and filtration system

The advanced cl-b ultra micro filtration system is adopted. The filter aid is added with the equal proportion of the filtrate to maintain sufficient permeability and ensure continuous and stable large flow rate. The patented dynamic sealing technology is used to completely eliminate capillary phenomenon, no leakage, waste of filtrate and pollution of working environment. The whole system has no leakage and no back cleaning, There is no filtrate residue, and the filter residue is dried and discharged, so there is no filtrate loss in the whole process. The impurities are effectively removed, and the purified antigen is obtained. The OD value is reduced by 50%, and the antigen titer is not lost.

6、 Ruibeishi Series in line with international standards

The whole set of inactivated vaccine production process of Mycoplasma hyopneumoniae from Pfizer company of the United States was introduced, and the new type of oil in water adjuvant process of aifeijin was adopted. The quality of the vaccine was in perfect accordance with that of imported products and reached the international level.

7、 Avian influenza vaccine takes the lead in China

1) The quality and safety of raw materials are strictly controlled. New methods are used to disinfect the eggs. The contamination ratio of semi-finished products is reduced. The yield per unit area of products is increased. The potency is increased and the production cost is reduced;

2) The advanced inoculation, harvesting and ultrafiltration equipment of TKA in Italy is adopted in the production of stock solution. The automatic equipment is used to reduce the pollution caused by manual operation, and the impurities in the original solution are effectively removed through ultrafiltration to ensure the purity of virus in the original solution and ensure the homogeneity and stability of the product;

3) Gold ratio of antigen: multiple antigens are prepared separately, the antigen content ratio is reasonable, and one injection can prevent multiple immune reactions;

4) Advantages of double emulsification technology

a. Temperature control of vaccine during emulsification: the emulsification process equipment in the tank is manufactured by IKA in Germany, and the tank body is cooled by low-temperature cooling water. During the process from the beginning to the end of emulsification, the temperature rise of the vaccine is not more than 1 ℃, which overcomes the disadvantage that the temperature of the vaccine will rise to 40 ℃ in the past. The effect of temperature rise in emulsification process on antigenic titer was avoided, and the efficacy of vaccine was not affected.

a. Temperature control of vaccine during emulsification: the emulsification process equipment in the tank is manufactured by IKA in Germany, and the tank body is cooled by low-temperature cooling water. During the process from the beginning to the end of emulsification, the temperature rise of the vaccine is not more than 1 ℃, which overcomes the disadvantage that the temperature of the vaccine will rise to 40 ℃ in the past. The effect of temperature rise in emulsification process on antigenic titer was avoided, and the efficacy of vaccine was not affected.

5) Select imported high quality white oil adjuvant

Compared with the similar products, the imported white oil adjuvant has low viscosity, convenient injection, easy dispersion in the injection site, and meets the requirements of USP, NF and FDA. The indexes and compatibility tests are carried out. If the viscosity of adjuvant is adjusted reasonably, the antibody level will rise rapidly, the titer will be high, and the maintenance period will be long. When the immune response of the body to the vaccine is improved, there will be no toxic and side effects on animals. Through technological innovation, the production technology of the products has gradually reached the international level, creating conditions for entering the high-end market and international market. At present, it has developed into one of the enterprises with the strongest production capacity of avian influenza vaccine in China.