Release potency tests of hepatitis vaccines.
SmithKline Beecham Biologicals produces two vaccines against hepatitis: hepatitis B (Engerix-B) introduced in 1986 and hepatitis A (Havrix) introduced in 1991. Using these two examples, we demonstrate the long and gradual transition process towards an in vitro release test for potency and a significant decrease in the number of animals needed for vaccine release.
Descamps
J
J
SmithKline Beecham Biologicals, Rixensart, Belgium.
Mary
A
A
Rommel
E
E
Anhoury
M L
ML
De Neys
R
R
Duchêne
M
M
D000826:Animal Testing Alternatives; D000818:Animals; D001681:Biological Assay; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies / Q000097:blood; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000276:immunology / Q000592:standards*; D006507:Hepatovirus / Q000276:immunology; D051379:Mice; D015164:Vaccines, Inactivated / Q000276:immunology / Q000592:standards*; D014614:Vaccines, Synthetic / Q000276:immunology / Q000592:standards*; D014761:Viral Hepatitis Vaccines / Q000276:immunology / Q000592:standards*
C075654:Engerix-B; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D015164:Vaccines, Inactivated; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines