Development and validation of a serological potency test for the release of Leptospira vaccines - Requirements in the European Union

被引：0

作者：

Balks, Elisabeth ^{[1
]}

Gyra, Heike ^{[1
]}

Kobe, Babett ^{[1
]}

Cussler, Klaus ^{[1
]}

Werner, Esther ^{[1
]}

机构：

[1] Paul Ehrlich Inst, Fed Inst Vaccines & Biomed, Vet Dept, Sect Bacterial Vaccines & Immune Sera, D-63225 Langen, Germany

来源：

BIOLOGICALS | 2013年 / 41卷 / 05期

关键词：

Leptospira; Vaccine; Batch potency; Alternative method; 3R; Serology; GUINEA-PIGS; CANDIDATES;

D O I：

10.1016/j.biologicals.2013.06.011

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Both European Pharmacopoeia Monograph 01/2008:0447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/2008:1939 "Bovine Leptospirosis vaccine (inactivated)" explicitly allow for a sero-response test to assess batch potency. Test setup and requirements for in vivo and in vitro validation are described. Furthermore, the two main strategies to assess batch potency and their specific demands are addressed. (C) 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

引用

页码：325 / 329

页数：5

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