%0 Report %D 2013 %T Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines %A Morgeaux,M. %A Variot,P. %A Daas,A. %A Costanzo,A. %K 2012 %K a %K an %K antibodies %K Antibody %K AS %K batch release %K Comparison %K Control %K Correlation %K detection %K Europe %K European %K Group %K Hepatitis %K Hepatitis A %K Hepatitis A Vaccines %K in vivo %K International %K Laboratories %K Medicine %K medicines %K method %K methods %K mice %K ON %K Order %K ph %K present %K Project %K routine %K SELECTED %K STANDARD %K study %K Test %K TESTING %K use %K vaccine %K vaccines %K Validate %K VALIDATION %K VIRUS %X 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 %I European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe %C Strasbourg, France %V December 2013 %P 29 %8 0/12/2013 %G eng %1 4823 %& 64