Reference standards for vaccine-producing laboratories.
The inherent variability of the biological systems used for production of vaccines is much greater than that encountered in the production of pharmaceuticals. Therefore, producers of vaccines must take particular care to ensure that the different batches of a vaccine are of reasonable consistency and that the immunising activity of each batch is equivalent to that of the vaccine originally shown to be effective in the target species. This struggle for consistency has been the main motive for developing the range of reference standards which serve as fixed reference points during the production and quality control of a vaccine.
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Council of Europe, European Pharmacopoeia Secretariat, Strasbourg, France.
D000818:Animals; D004355:Drug Stability; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D012015:Reference Standards; D014612:Vaccines / Q000592:standards*
D014612:Vaccines