The quantitative ELISA for inactivated Newcastle disease virus antigen: development of the test system and the way to a Ph. Eur in vitro potency test.
The development of an alternative in vitro potency test required experimental studies, which were performed in-house and in collaboration with other laboratories (Official Medicines Control Laboratories, Manufacturers), coordinated by EDQM (European Directorate for the Quality of Medicines & HealthCare). This paper provides background information concerning the development of the quantitative ELISA for inactivated Newcastle disease virus (NDV) antigen, which was added in the European Pharmacopoeia monograph as an in vitro batch potency test.
Medicines Evaluation Board (CBG-MEB), The Hague, Netherlands. hl.oei@cbg-meb.nl
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D000818:Animals; D000956:Antigens, Viral / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D015707:HN Protein / Q000276:immunology; D009521:Newcastle Disease / Q000276:immunology / Q000517:prevention & control; D009522:Newcastle disease virus / Q000276:immunology*; D015203:Reproducibility of Results; D014611:Vaccination / Q000662:veterinary; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage / Q000276:immunology*
D000956:Antigens, Viral; D015707:HN Protein; D015164:Vaccines, Inactivated; D014765:Viral Vaccines