PMID: 20650161Dec 1, 1995Paper

Development, validation and acceptance of alternative methods in the quality control of vaccines: A case report

Toxicology in Vitro : an International Journal Published in Association with BIBRA
C F Hendriksen

Abstract

Information about levels of protection against tetanus is needed both for the assessment of immune status and for the estimation of the potency of batches of tetanus toxoid. Originally, levels of protective antibodies in human serum samples were titrated in an in vivo toxin neutralization (TN) test. Potency testing was based either on an indirect protection test or a direct challenge test. In the former test, rabbits or guinea pigs are immunized and bled, followed by titration of serum samples in a TN test. In the latter test, used in the quality control of tetanus toxoid for human use, protective immunity is induced by vaccination in guinea pigs or mice and subsequently challenging them directly with tetanus toxin. In the mid-1980s, an in vitro model was developed at the National Institute of Public Health and Environmental Protection (RIVM) for estimating levels of tetanus antitoxin in serum samples. This model, the toxin-binding inhibition (ToBI) test, was validated recently for both diagnostic testing and potency testing. Although accurate estimation of antitoxin levels is more important for diagnostic testing than for potency testing, the ToBI test has been adopted for determining the immune status but not for potency test...Continue Reading

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Citations

Dec 1, 1995·Toxicology in Vitro : an International Journal Published in Association with BIBRA·M Balls
Feb 19, 2002·Fertility and Sterility·Larry S AbramsFrankie A Wong
Jun 7, 2003·Toxicology and Applied Pharmacology·Esther F A BrandonJan H M Schellens
Mar 15, 2002·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·A J Hayes, B Markovic
Jan 31, 2014·Biologicals : Journal of the International Association of Biological Standardization·Fabiana Belasco GuilhenMartha Harumi Sonobe
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May 26, 1998·Environmental Health Perspectives·H Spielmann
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Nov 1, 2007·Current Protocols in Toxicology·Laura Gribaldo
Dec 18, 2013·Birth Defects Research. Part C, Embryo Today : Reviews·Chi Chiu WangKwok Pui Fung

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