Establishment of the Ph. Eur. BRP for Varicella Vaccine Batch 1227

Last updated on 22-8-2019 by Anonymous (not verified)

Peer reviewed scientific article

SCIENSANO

Abstract:

The European Pharmacopoeia (Ph. Eur.) monograph for varicella vaccine (live) (0648) requires a vial of an appropriate reference material to be titred in triplicate to validate each assay and the virus concentration of the reference preparation is monitored using a control chart to determine the assay consistency. An international collaborative study involving 9 participants from 7 countries and including both OMCLs and manufacturers was carried out to establish a common reference material for this purpose and establish a Ph. Eur. Biological Reference Preparation. Two candidate reference pre…

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