Full Description

This document describes a process validation protocol for establishing the amount of removal/inactivation of various viruses in ABx and Fast Flow Q (FF Q) process murine monocloncal antibody 12.8 from ascites when passed over a Flast Flow Sulfanate (FF S) column as described in Master Batch Records. Experiments using a scaled-down column diameter keeping equivalent column heights, linear flow velocities, buffer volumes and sample loads per unit chromatographic matric used in the manufacturing process. Sample load represents the maximum load per unit gel allowed in the process scale. The scale down by column diamter is approximately 1/40th for the FF S column. This procedure is suitable for determing the extent of virus removal for submission to regulatory agencies. The PV Report is available as 02-0013-PVR-1.0.

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Edition: 1 Published: 11/01/2004 Number of Pages: 10