Published on July 13, 2016
1. Represent By: Somia Sahar BS (Microbiology)
2. Vaccine is a biological preparation that provides active acquired immunity to a particular disease. Vaccine is a suspension of organism that is used to induced immunity.
3. Vaccine are produced in large scale as they need to be administered to large population of children and adults to be effective as public health tool. To synthesize a live attenuated vaccine the disease causing organisms is grown under laboratory conditions that cause to lose its disease causing properties.
4. The attenuated can be obtained by heat or by passage of the virus in foreign host such as embryonated eggs & tissue culture cells. Cell culture required for viral vaccine since virus can replicate inside the living cells. e.g. to produce Sabin polio vaccine attenuated was only achieved with high inocula and rapid passage in primary monkey kidney cells.
5. 1- Generation of the antigen 2-Release and isolation of the antigen 3-Purification 4-Addition of other components 5-Packaging
6. For this purpose the pathogen’s protein and DNA need to be grown & harvested using the following mechanism: Viruses are grown on primary cells such as cell from chicken embryos or using fertilised eggs or cell line. Bacteria are grown in bioreactors. Recombinant proteins derived from the pathogens can be generated in yeast, bacteria or cell culture.
7. The aim of this is to release as much viruses or bacteria as possible. To achieve this the antigen will be separated from the cell & isolate from the protein & other parts of the growth medium that are still present.
8. The antigen will need to be purified in order to produce high quality product. For weakened or attenuated viruses no further purification may required. Recombinant protein may need many operations involving ultra filtration & column chromatography for purification before they are ready for administration.
9. Once the antigen is developed the vaccine is formulated by adding adjutants stabilizer & preservatives. Adjutants enhance the immune response of the antigen. Stabilizer increase the storage life. Preservatives allow the use of multi dose vials.
10. The product need to be protected from air, water and human contamination. The environment need to be protected from spillage of the antigens.
11. Once the vaccine is put in the recipient vessels it is sealed with sterile stoppers. GMPs will involve several quality controls and an adequate infrastructure and separation of activities to avoid cross contamination. Finally the vaccine is labeled and distributed worldwide.
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