id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-331739-y1d0leic	Kempf, Christoph	Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins	2007-03-31		.txt	text/plain	5089	287	42	Since plasma pools from 250 to 2000 blood donations were being used to produce albumin, efforts were initiated to inactivate hepatitis virus in human serum albumin solutions [6] . The emergence of human immunodeficiency virus (HIV) and reports of non-A, non-B hepatitis transmission by some IVIG products [11, 12] but not others caused manufacturers and regulatory agencies to examine existing IVIG manufacturing processes for their capacity to eliminate viruses [13e22]. Studies of IVIG manufacturing procedures suggested that cold ethanol fractionation removes viruses by two mechanisms: 1) inactivation and 2) partitioning. Efficient elimination of TSE infectivity from IgG solutions by Table 3 Log 10 reduction factors of model viruses observed during laboratory experiments of IVIG production (Carimune NF Ò ) Process (step in Fig. 1 [53] . To date IVIG therapeutics have reached a high safety standard due to consequent blood and plasma testing and the introduction of virus elimination steps in the manufacturing process.	./cache/cord-331739-y1d0leic.txt	./txt/cord-331739-y1d0leic.txt