Development and validation of a serological potency test for the release of Leptospira vaccines--requirements in the European Union.
Biologicals
; 41(5): 325-9, 2013 Sep.
Article
in En
| MEDLINE
| ID: mdl-23911253
ABSTRACT
Both European Pharmacopoeia Monograph 01/20080447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/20081939 "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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bacterial Vaccines
/
Cattle Diseases
/
Dog Diseases
/
Vaccine Potency
/
Leptospira
/
Leptospirosis
Limits:
Animals
Language:
En
Journal:
Biologicals
Journal subject:
ALERGIA E IMUNOLOGIA
Year:
2013
Document type:
Article
Publication country:
ENGLAND
/
ESCOCIA
/
GB
/
GREAT BRITAIN
/
INGLATERRA
/
REINO UNIDO
/
SCOTLAND
/
UK
/
UNITED KINGDOM