Table 3-2

LDAO Virus Inactivation Robustness Study Test Conditions

ParameterConditionLDAO Conc. (%)Material
MaterialHCCF pH 7.0 (15 mS/cm)
CCF pH 7.4 (13.5 mS/cm)
ACCF and HCCF
Native cond/set-point pH
Protein Conc.High (70 mg/mL)
Mid (20 mg/mL)
Low (9 mg/mL) (Standard conc)
AHCCF pH 7.0, 15 mS/cm
LDAO Conc.Native HCCFA
B
C
D
HCCF pH 7.0, 15 mS/cm
ConductivityHigh—25 mS/cm
Mid—15 mS/cm
Low—5 mS/cm
Buffer Control—5 mS/cm
AHCCF pH 7.0
pHpH 8.0
pH 7.0
pH 6.0
AHCCF, 15 mS/cm