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Standardization of the methods and reference materials used to assess virus content in varicella vaccines

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Issue Date
2015-07-05
Publisher
BioMed Central
Citation
Virology Journal, 12(1):101
Keywords
VaricellaVaccineVirus contentNational Center for Lot ReleaseKorean reference material
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 manufacturers 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.
Language
English
URI
https://hdl.handle.net/10371/109838
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College of Veterinary Medicine (수의과대학)Dept. of Veterinary Medicine (수의학과)Journal Papers (저널논문_수의학과)
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