Production of the Bacteria and the Cellular Components of Bacterial Vaccines
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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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