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Autor:
Thomas P. Zimmerman, Jennifer L. Culp, Todd Willis, Clark Zervos, Rebecca Silverstein, Pete Vandeberg, Vickie Barham, David A. Malinzak, Doug Burns, Melanie Williams, Amy Durham, Jyoti Srivastava, Greg Flexman
Publikováno v:
Biologicals. 59:12-19
A sudden, unprecedented failure of USP rabbit pyrogen tests for multiple 10% IGIV-C lots prompted a thorough investigation of the root cause for this phenomenon. All microbe-related testing, including Limulus amebocyte lysate test for endotoxin, prov