<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Akkermans,A.</style></author><author><style face="normal" font="default" size="100%">Geneviève Waeterloos</style></author><author><style face="normal" font="default" size="100%">Kemiha,K.</style></author><author><style face="normal" font="default" size="100%">Daas,A.</style></author><author><style face="normal" font="default" size="100%">Milne,C.</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Establishment of the Ph. Eur. BRP for Varicella Vaccine Batch 1227</style></title><secondary-title><style face="normal" font="default" size="100%">Pharmeur.Bio Sci.Notes</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">2009</style></keyword><keyword><style  face="normal" font="default" size="100%">a</style></keyword><keyword><style  face="normal" font="default" size="100%">an</style></keyword><keyword><style  face="normal" font="default" size="100%">AS</style></keyword><keyword><style  face="normal" font="default" size="100%">at</style></keyword><keyword><style  face="normal" font="default" size="100%">Common</style></keyword><keyword><style  face="normal" font="default" size="100%">Control</style></keyword><keyword><style  face="normal" font="default" size="100%">Countries</style></keyword><keyword><style  face="normal" font="default" size="100%">data</style></keyword><keyword><style  face="normal" font="default" size="100%">Establish</style></keyword><keyword><style  face="normal" font="default" size="100%">EU</style></keyword><keyword><style  face="normal" font="default" size="100%">European</style></keyword><keyword><style  face="normal" font="default" size="100%">International</style></keyword><keyword><style  face="normal" font="default" size="100%">IS</style></keyword><keyword><style  face="normal" font="default" size="100%">method</style></keyword><keyword><style  face="normal" font="default" size="100%">methods</style></keyword><keyword><style  face="normal" font="default" size="100%">ON</style></keyword><keyword><style  face="normal" font="default" size="100%">PARTICIPANTS</style></keyword><keyword><style  face="normal" font="default" size="100%">ph</style></keyword><keyword><style  face="normal" font="default" size="100%">stability</style></keyword><keyword><style  face="normal" font="default" size="100%">study</style></keyword><keyword><style  face="normal" font="default" size="100%">use</style></keyword><keyword><style  face="normal" font="default" size="100%">vaccine</style></keyword><keyword><style  face="normal" font="default" size="100%">Validate</style></keyword><keyword><style  face="normal" font="default" size="100%">VIRUS</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2009</style></year><pub-dates><date><style  face="normal" font="default" size="100%">0/10/2009</style></date></pub-dates></dates><number><style face="normal" font="default" size="100%">54</style></number><volume><style face="normal" font="default" size="100%">2009-1</style></volume><pages><style face="normal" font="default" size="100%">45 - 54</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">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 preparations (X and Y), obtained from 2 different EU manufacturers, were assayed by the participants using their in-house PFU assay methods. Both candidates were found to be suitable for this purpose. Based on logistical considerations, candidate X (4.37 log10 PFU/vial) has been established as BRP batch 1 of varicella vaccine (live) and was adopted at the June 2009 session of the European Pharmacopoeia Commission for immediate use. Candidate Y (3.82 log10 PFU/vial) will be established as BRP batch 2 upon depletion of BRP batch 1 provided that the stability data supports this.</style></abstract><custom1><style face="normal" font="default" size="100%">38483</style></custom1><section><style face="normal" font="default" size="100%">45</style></section></record></records></xml>