Inactivated rabies vaccine control and release: use of an ELISA method.
Quality control of human rabies vaccines performed by National Control Laboratories (NCLs) prior to marketing vaccines batches requires in vivo and in vitro potency assays as requested by the relevant European Pharmacopoeia monographs, OMCLs guidelines and WHO technical recommendations. The aim of the present study was to check the suitability of an enzyme-linked immunosorbent assay (ELISA) using a virus neutralizing monoclonal antibody, directed to the rabies virus glycoprotein, to monitor the consistency of the lot to lot rabies vaccines production. Furthermore, this work was implemented to establish in house specifications for the glycoprotein content.
Fournier-Caruana
Jacqueline
J
Agence Française de Sécurité Sanitaire des Produits de Santé, Direction des Laboratoires et des Contrôles, 321 avenue Jean Jaurès, 69007 Lyon, France.
Poirier
Bertrand
B
Haond
Geneviève
G
Jallet
Corinne
C
Fuchs
Florence
F
Tordo
Noël
N
Perrin
Pierre
P
D004306:Dose-Response Relationship, Immunologic; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006801:Humans; D011786:Quality Control; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000592:standards*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000592:standards*
D011819:Rabies Vaccines; D015164:Vaccines, Inactivated