Production of the Bacteria and the Cellular Components of Bacterial Vaccines

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Chapter: Pharmaceutical Microbiology : The Manufacture And Quality Control Of Immunological Products

The bacteria and cellular components needed for the manufacture of most bacterial vaccines are prepared in laboratory media by well-established fermentation methods.


PRODUCTION OF THE BACTERIA AND THE CELLULAR COMPONENTS OF BACTERIAL VACCINES

 

The bacteria and cellular components needed for the manufacture of most bacterial vaccines are prepared in laboratory media by well-established fermentation methods. The end-product of the fermentation, the harvest, is processed to provide a concentrated and purified bulk lot of vaccine component that may be conveniently stored for long periods or even sold to other manufacturers prior to further processing. It is important that the materials, equipment, facilities and working practices are of a standard acceptable for the manufacture of pharmaceutical products. The requirements for this are defined as Good Manufacturing Practice (GMP). Guidelines on the basic requirements have been published by WHO (1999a, 1999b).

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