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This document is a process validation report that describes the Conclusions and Recommendations of a successfully completed PV protocol for the removal/inactivation of various viruses in ABx purified 12.8 when passed over a Flast Flow Sulfanate (FF S) column. Includes Results & Analysis sections for each data collection form identified in the PV protocol, 02-0013-PVP-1.0. Data tables include endogenous ecotropic retrovirus removal, poliomyelitis virus removal, pseudorabies virus removal, buffer effects, and summary of virus recovery. Discrepancies section includes correspondence with FDA regarding the relative importance of performing spiking studies to evaluate removal of various virus classes.

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Edition: 1 Published: 11/01/2004 Number of Pages: 24