Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines
Morgeaux, M. Variot, P. Daas, A. Costanzo, A.
Morgeaux, M.
Variot, P.
Daas, A.
Costanzo, A.
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Abstract
The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of hepatitis A virus antigen content in hepatitis A vaccines(HAV) marketed in Europe. This became necessary due to issues with the method used previously, requiring the use of commercial test kits. The selected candidate method, not based
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Date
2013-12-15
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European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe
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Publication type
Sci. report, recommendation, guidance doc., directive, monograph
Research Projects
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Keywords
2012, a, an, antibodies, Antibody, AS, batch release, Comparison, Control, Correlation, detection, Europe, European, Group, Hepatitis, Hepatitis A, Hepatitis A Vaccines, in vivo, International, Laboratories, Medicine, medicines, method, methods, mice, ON, Order, ph, present, Project, routine, SELECTED, STANDARD, study, Test, TESTING, use, vaccine, vaccines, Validate, VALIDATION, VIRUS