Standardization of the methods and reference materials used to assess virus content in varicella vaccines.
Virol J
; 12: 101, 2015 Jul 05.
Article
en En
| MEDLINE
| ID: mdl-26141063
ABSTRACT
BACKGROUND:
In Korea, every vaccine lot is tested by the National Center for Lot Release (NCLR) in accordance with the national lot release procedures to ensure the safety and efficacy of vaccines. These quality tests examine the virus content in varicella vaccines via plaque assays (either the agar overlay method [AOM] or plaque staining method [PSM]), according to the procedures suggested by the Korean Reference Material for the Varicella Vaccine (KRMVV) or the manufacturer's standard in-house protocol.AIM:
To standardize the virus content tests, viral titers in the KRMVV were measured using the PSM at four participating laboratories in a collaborative study. With the aim of developing a standardized method using the KRMVV as a positive control, we compared the ability of the two test methods, AOM and PSM, to accurately and reproducibly determine the virus content of two commercial varicella vaccines.RESULTS:
The results showed that the standardized method (PSM) was more suitable for quality control analysis of the varicella vaccine.CONCLUSION:
Use of a standardized method (PSM) according to the Korean reference material will improve the reliability and objectivity of lot release testing.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Tecnología Farmacéutica
/
Vacuna contra la Varicela
/
Carga Viral
Tipo de estudio:
Clinical_trials
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Virol J
Asunto de la revista:
VIROLOGIA
Año:
2015
Tipo del documento:
Article