NR AESF
AU Gölker,C.F.; Whiteman,M.D.; Gugel,K.H.; Gilles,R.; Stadler,P.; Kovatch,R.M.; Lister,D.; Wisher,M.H.; Calcagni,C.; Hübner,G.E.
TI Reduction of the infectivity of scrapie agent as a model for BSE in the manufacturing process of Trasylol
QU Biologicals 1996 Jun; 24(2): 103-11
PT journal article
AB The Trasylol manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs used in the Trasylol manufacturing plant were taken and spiked in laboratory scale experiments with high infectious titres of the rodent adapted scrapie strain ME 7 which served as model for BSE. After performing the respective process steps the output samples collected were tested in C57BL mice carrying the Sinc gene. An overall reduction of the infectious agent in the order of 18 log10 was observed, indicating a very high capacity of the Trasylol process for the inactivation/removal of the BSE/scrapie agent. The discussed safety strategy for the product leads to the conclusion that Trasylol is BSE safe.
IN 4 Schritte des Herstellungsprozesses des von Bayer aus Rinderlungen gewonnenen Proteinase-Inhibitors Aprotinin mit antifbrinolytischer Wirkung wurde mit einem Zusatz von Scrapie-Erregern in hoher Konzentration simuliert, um die BSE-Sicherheit dieses Produktes zu überprüfen. Die Autoren behaupten, eine Reduktion der Infektivität um 18 log(10)-Einheiten gefunden zu haben. Derartige Abreicherungsfaktoren lassen sich experimentell nicht beobachten und gehen von der irrigen Annahme aus, dass die Restinfektiosität nach einer Behandlung durch eine nachgeschaltete Behandlung im gleichen Maße abnehme, wie im Rohmaterial.
ZR 41
MH Animal; Aprotinin/*chemical synthesis; Cattle; Encephalopathy, Bovine Spongiform/pathology/*virology; Mice; Mice, Inbred C57BL; PrPsc Proteins/*pathogenicity; Thalamus/pathology
AD Bayer AG, Wuppertal, Germany.
SP englisch
PO England
OR Prion-Krankheiten G