NR AMAJ
AU Vey,M.; Baron,H.; Weimer,T.; Gröner,A.
TI Purity of spiking agent affects partitioning of prions in plasma protein purification
QU Biologicals 2002 Sep; 30(3): 187-96
PT journal article
AB Prions are not detectable in the blood or plasma of persons afflicted with classical or variant Creutzfeldt-Jakob disease, and they have never been shown to be transmitted by blood or plasma products. Despite the uncertainty as to the presence and biophysical properties of prions in plasma, prion removal studies have been conducted using brain homogenate or microsomes prepared from prion-infected rodent brains as model prions. In this study, we compare the partitioning of different prion spiking agents, having different biophysical properties, in the processes used for plasma protein purification. We have found that membrane-bound prion spiking agents partition similarly, whereas purified, unbound pathogenic prion proteins can have significantly different partitioning properties depending on the conditions in the production process. We conclude that prion spiking studies for the evaluation of prion reduction in plasma protein purification should employ spiking agents with different biophysical properties to mimic partitioning of the theoretical prion contaminant. This will give greater assurance as to the prion safety margins of the life-saving plasma protein therapeutics and excipients.
AD M.Vey, T.Weimer, A.Gröner, Aventis Behring GmbH, P.O. Box 1230, 35002, Marburg, Germany; H.Baron, Aventis Behring S.A. 46 Quai de la Rapee, 75601, Paris, Cedex 12, France
SP englisch
PO England