產品資訊 - Vaccinate Inactivated Influenza Vaccine->aspalthic products

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Changchun Changsheng Life Sciences Ltd.

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Vaccinate Inactivated Influenza Vaccine

產品分類 :

化學->化學用品->aspalthic products

產品規格

Model No:	0.25ml/vial or 0.25ml/syringe

Country	CN
Minimum Order	5000
Payment Term	L/C,T/T

產品描述

Influenza Vaccine (Split Virion), Inactivated 
Influenza Vaccine (Split Virion) is a preparation made from the prevalent strains of influenza virus type A and type B recommended by WHO and approved by the NRA. The strains of influenza virus type A and type B are grown separately in embryonated chicken eggs. After cultivation, the virus suspensions in allantoic cavities are harvested, inactivated, purified,disrupted and repurified to make the vaccine. It is used to prevent the infections of the prevalent strains of influenza viruses. 
1 Basic requirements 
The facilities, source and subsidiary materials, water, apparatus and animals used for production and control tests of biologics shall comply with the requirements set forth in the General Notices. 
2 Manufacturing 
2.1 Embryonated eggs for vaccine production 
Specific pathogen free (SPF) chick embryos shall be used for the preparation and passage of virus seeds. The embryonated eggs derived from closed healthy flocks shall be used for the vaccine production. The embryos of 9-11 days old shall be in active status with vivid blood vessels and free of any aberrations. 
2.2  Virus seeds 
2.2.1  Name and origin of virus strains 
The virus seeds used for the vaccine production shall be the approved strains of influenza type A and type B viruses recommended and supplied by the WHO. 
2.2.2  Establishment of seed lot system 
It complies with the Requirements for Bacterial and Virus Strains/Seeds Used for Production and Quality Control of Biologics. Based on the passage number of the virus recommended and supplied by the WHO, the master seed lot and working seed lot shall be established by subculture of the virus. And the total number of passages of the virus to the final product shall not exceed five passages.  
2.2.3  Control tests on virus seed lots 
For master seed lot, control tests described below shall be conducted; for working seed lot, tests described in Sections 2.2.3.1-2.2.3.5 shall be carried out at least. 
2. 2. 3. 1   Identity test 
Haemagglutination inhibition test shall be performed with corresponding subtype specific immune serum for typing identification of the haemagglutinin. The result shall prove that the antigenicity of the test virus i.s in compliance with that of the recommended virus strain. 
2. 2. 3. 2   Virus titer 
The 50% embryo-infective does (EID50) is employed for the virus titration. The virus titer shall be not less than 6.5 lg EID50/ml. 
2. 2. 3. 3  Haemagglutinin (HA) titer 
The HA titer shall be not less than 1: 160 determined by haemagglutination method. 
2. 2. 3. 4   Sterility test 
It complies with the test for sterility (Appendix XII A). 
2. 2. 3. 5  Tests for mycoplasmas 
It complies with the test for mycoplasmas (Appendix XII B). 
2. 2. 3. 6   Tests for adventitious avian leucosis viruses 
Neutralize the seed virus with corresponding sybtype specific antiserum. Inoculate the neutralized material onto SPF embryonic fibroblast cell cultures. After incubation, the cultures are tested by ELISA.  The result shall be negative. 
2. 2. 3. 7   Tests for adventitious avian adenoviruses 
Neutralize the seed virus with corresponding subtype specific antiserum. Inoculate the neutralized material onto SPF embryonic hepatic cell cultures. After incubation, the cultures are tested for avian adenoviruses type I and type III by suitable serologic methods, respectively. All the results shall be negative. 
2. 2. 4   Storage of virus seed lots 
The freeze-dried virus seeds shall be stored at or below -20℃ , the liquid ones shall be stored at or below - 60℃ . 
2. 3   Monovalent vaccine bulk 
2. 3. 1   Virus inoculation and cultivation 
Inoculate a quantity of appropriately diluted virus from working seed lot into the allantoic cavities of embryonated eggs. Each strain of influenza virus shall be inoculated at the same virus titer. Incubate the inoculated eggs at 33-35℃ for 48-72 hours. The remaining thawed seed virus, if any, is not allowed to freeze for further use. 
2. 3. 2   Virus harvest 
After incubation, collect the living embryos and cool at 2-8℃ for a period of time. Harvest the allantoic fluids into containers. Take a sample from each of the containers for control tests. 
2. 3. 3   Control tests on allantoic fluid harvests 
2. 3. 3. 1   Mircobial limit test 
The "Bacterial, fungi or yeasts count"  (Appendix XII G) shall apply. 
The number of microorganisms shall be less than 105 CFU/ml and the test for Salmonella paratyphi B shall be negative. 
2. 3. 3. 2   Haemagglutinin (HA)  titer 
The HA titer shall be not less than 1: 160 determined by haemagglutination method. 
2. 3. 4   Allantoic fluid harvests pooling 
The qualified allantoic fluid harvests of monovalent influenza virus in each of containers can be pooled into a monovalent virus pool. 
2. 3. 5  Inactivation of virus 
Virus inactivation shall be performed within the prescribed range of the protein content. Add formaldehyde into the monovalent virus pool to the final concentration of not more than 200 μg/ml for virus inactivation at an appropriate temperature for a period of time. At the end of inactivation, take a sample from each of the virus inactivation containers immediately to perform the validation test for virus inactivation and the test for bacterial endotoxin (A quantity of formaldehyde solution may be added for virus inactivation after purification) . 
2. 3. 6   Concentration and purification 
2. 3. 6. 1   Concentration by ultrafiltration 
After clarification by centrifugation or other suitable methods, the inactivated monovalent virus pool shall be concentrated by ultrafiltration to the prescribed range of the protein content. The concentrated virus suspension shall be sampled for the determination of bacterial endotoxin content. 
2. 3. 6. 2   Purification 
Carry out the purification of the ultrafilter-concentrated virus suspension by column chromatography or by sucrose density gradient zonal centrifugation. If the latter method is adopted, the sucrose shall be removed by means of ultrafiltration. Take a sample from the purified virus suspension for the determination of the protein content. 
2. 3. 7  Disruption of virions 
The disruption of virions shall be performed within the prescribed range of the protein content. Add the chemicals used for the virus disruption at an appropriate concentration into the monovalent virus pools for the disruption of the virions under proper conditions. 
2. 3. 8  Purification after virion-disruption 
Carry out the repurification of the disrupted-virion suspension by column chromatography or by sucrose density gradient zonal centrifugation. If the latter method is adopted, the sucrose shall be removed by means of ultrafiltration. Take a sample from the purified disrupted-virion suspension for testing the bacterial endotoxin and microbial limit. The number of contaminating microorganisms shall be less than 10 CFU/ml. 
2. 3. 9  Sterilization by filtration 
Add thimerosal at an appropriate concentration as preservative into the purified, disrupted-virion suspension which has been sterilized by filtration to make the monovalent bulk. 
2. 3. 10  Control tests on monovalent bulk 
See Section 3. 1. 
2. 3. 11   Storage of monovalent bulk 
The monovalent bulk shall be stored at 2-8℃ . 
2. 4   Final bulk 
2. 4. l   Formulation 
According to the haemagglutinin contents of respective monovalent bulks, the final bulk shall be formulated on the basis of the same haemaglutinin content of respective monovalent influenza viruses (The content of haemagglutinin for the formulation should be adjusted to 30 to 36 μg/dose and the formulation shall be carried out every year according to the same hemaglutinnin content for respective influenza virus strains). Thimerosal at an appropriate concentration may be added as a preservative to make the final bulk. 
2. 4. 2   Control tests on final bulk 
See Section 3. 2. 
2. 5   Final product 
2. 5. 1  Defining batches 
It complies with the Requirements for Defining Batches of Biologics. 
2. 5. 2   Filling 
It complies with the Requiretnents for Filling and Lyophilization of Biologics. 
2. 5. 3  Specifications 
0.25 ml or 0.5 ml per container. 0.25 ml ml per single human dose ( for children aged from 6 months to 3 years) shall contain 7.5 μg of haemag glutinin of each virus strain; or 0.5 ml per single human-dose (for adults and children aged above 3 years) shall contain 15 μg of haemagglutinin of each virus strain. 
2. 5. 4   Packaging 
It complies with the Requirements for Packaging of Biologics. 



[Function and use]


The product can induce immunity against influenza virus in recipients following immunization. It is used to prevent the infections of the prevalent strains of influenza viruses.


[Description]


The influenza vaccine (split virion) is a preparation made from the WHO recommended prevalent strains of influenza virus type A and type B which are grown separately in embryonated chicken eggs. After incubation, the virus suspensions in allantoic cavities are harvested. The vaccine is prepared by inactivation, concentration, purification and disruption of the virus. It is a slightly milky-white liquid, containing thimerosal as a preservative.


Active constituent: Influenza haemagglutinin derived from each of prevalent influenza virus strains in that very year. (The name of each of virus strains and the content of haemagglutinin shall be included. )


Subsidiary materials: All the components of subsidiary materials approved shall be listed.


[Specifications]


0. 25 ml or 0.5 ml per container.  0.25 ml per single human dose (used for children aged between 6 months and 3 years) .shall contain 7.5 μg of influenza haemagglutinin of each influenza virus strain. 0.5 ml per single human dose (used for adult and children aged above 3 years) shall contain 15 μg of influenza haemagglutinin of each influenza virus strain.

<img src="http://i.bosscdn.com/product/3d/dc/59/1f256c01a88a1bd1d43adbcc69.png@watermark=2&color=I0ZGRkZGRg%3D%3D&type=ZHJvaWRzYW5zZmFsbGJhY2s%3D&size=22&p=9&t=80&text=Y3MtdmFjY2luZS5ib3NzZ29vLmNvbQ%3D%3D" title="Influenza" alt="Influenza" /> 


 


 



 
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