期刊
BIOLOGICALS
卷 36, 期 2, 页码 142-143出版社
ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2007.02.001
关键词
plasma fractionation; variant CJD; TSE agents; prion agents; clearance; TSE preparations
Manufacturers of plasma derivatives are encouraged to perform product-specific investigational studies on the ability of their processes to remove prion agents. Such studies are invariably performed using spiking materials derived from infected brain tissue. However, there is little guidance available on which preparations are suitable and no consensus on the acceptability of resultant data. Further research is required to resolve this question. (c) 2007 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.
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