Table V

Impact of pH, Conductivity, and Temperature on Virus Clearance

DoE PatternLRV
pH (Buffer, Load)Conductivity (Buffer, Load)TemperatureXMuLVMMVSV40
+≥5.9≥5.2≥5.2
+++6.0≥5.2≥5.2
+≥5.8≥5.1≥5.1
+≥5.8≥5.0≥5.1
000≥5.9≥5.2≥5.2
+a+aa5.8≥4.95.4
  • a Most significant chromatogram shape change for this mAb.