<?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%">A M Akkermans</style></author><author><style face="normal" font="default" size="100%">Geneviève Waeterloos</style></author><author><style face="normal" font="default" size="100%">K Kemiha</style></author><author><style face="normal" font="default" size="100%">A Daas</style></author><author><style face="normal" font="default" size="100%">C Milne</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.</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%">Antibodies, Viral</style></keyword><keyword><style  face="normal" font="default" size="100%">Chickenpox Vaccine</style></keyword><keyword><style  face="normal" font="default" size="100%">Europe</style></keyword><keyword><style  face="normal" font="default" size="100%">Freeze Drying</style></keyword><keyword><style  face="normal" font="default" size="100%">Herpesvirus 3, Human</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Pharmacopoeias as Topic</style></keyword><keyword><style  face="normal" font="default" size="100%">Reference Standards</style></keyword><keyword><style  face="normal" font="default" size="100%">Reproducibility of Results</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%">2009 Oct</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">2009</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;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 log(10)0 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 log(10) PFU/vial) will be established as BRP batch 2 upon depletion of BRP batch 1 provided that the stability data supports this.&lt;/p&gt;
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