Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines

Last updated on 23-8-2019 by Anonymous (not verified)

Sci. report, recommendat°, guidance doc., directive, monograph



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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