Vaccine production somia

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Information about Vaccine production somia

Published on July 13, 2016

Author: nomank992

Source: slideshare.net

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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