Amgen Study Evaluating Clearance of xMuLV by caprylate Precipitation from a Purified mAb Solution
Run | Sample | Copies per Sample | TCID50 LRV | qPCR LRV |
---|---|---|---|---|
Hold Control (no caprylate), pH 5.1 | Pre-filter | 2.48E+12 | ||
Post-filter | 3.93E+11 | 0.8 | 0.8 | |
60 mM Caprylate, pH 4.9 | Pre-filter | 4.33E+12 | ||
Post-filter | 5.85E+07 | ≥3.4 | 4.9 | |
60 mM Caprylate, pH 5.1 | Pre-filter | 4.07E+12 | ||
Post-filter | 1.90E+07 | ≥4.2 | 5.3 | |
60 mM Caprylate, pH 5.3 | Pre-filter | 4.19E+12 | ||
Post-filter | 1.63E+06 | ≥3.4 | 6.4 |