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. 2011 Jul 3;79(3):569–581. doi: 10.3797/scipharm.1104-18

Tab. 5.

Factors and levels evaluated in the robustness assays.

Factor ID Factor classific. Limit Low Level (−) High Level (+) Nominal Level
Cell Culture Media manufacturer G qual. GIBCO PAA GIBCO
Fetal Bovine Sera manufacturer E qual. GIBCO PAA GIBCO
Time of Trypsinization I quant. ±1 min 11 min (A431)
2 min (H125)
13 min (A431)
4 min (H125)
12 min (A431)
3 min (H125)
Trypsin-EDTA manufacturer B qual. GIBCO PAA GIBCO
Incubation time for EGFR recovery A quant. ±10 min 50 min 70 min 60 min
Incubation time of mAb C quant. ±5 min 25 min 35 min 30 min
Incubation time of FITC-conjugated H quant. ±5 min 25 min 35 min 30 min
Volume of mAb D quant. ±5 μL 15 μL 25 μL 20 μL
Volume of FITC-conjugated K quant. ±5 μL 15 μL 25 μL 20 μL
Formaldehyde cell fixation J qual. No Yes No