肝炎疫苗释放效价试验。

Developments in biological standardization Pub Date : 1999-01-01

J Descamps, A Mary, E Rommel, M L Anhoury, R De Neys, M Duchêne

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摘要

SmithKline Beecham biicals生产两种肝炎疫苗:1986年推出的乙型肝炎(Engerix-B)和1991年推出的甲型肝炎(Havrix)。通过这两个例子，我们展示了向效力体外释放试验过渡的漫长而渐进的过程，以及疫苗释放所需动物数量的显著减少。

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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.

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Developments in biological standardization

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