TABLE VI

Amgen Study Evaluating Clearance of xMuLV by caprylate Precipitation from a Purified mAb Solution

RunSampleCopies per SampleTCID50 LRVqPCR LRV
Hold Control (no caprylate), pH 5.1Pre-filter2.48E+12
Post-filter3.93E+110.80.8
60 mM Caprylate, pH 4.9Pre-filter4.33E+12
Post-filter5.85E+07≥3.44.9
60 mM Caprylate, pH 5.1Pre-filter4.07E+12
Post-filter1.90E+07≥4.25.3
60 mM Caprylate, pH 5.3Pre-filter4.19E+12
Post-filter1.63E+06≥3.46.4