TABLE III

Effectiveness of Resin Regeneration Procedure in Inactivating/Removing Retroviruses

SampleTotal Log10 TCID50 or PFU of Indicated Sample
Case ICase IICase III
First RunaSecond RunFirst RunaSecond RunFirst RunaSecond Run
Exp. AExp. BExp. AExp. BExp. AExp. BExp. AExp. BExp. AExp. BExp. AExp. B
Spiked Load7.677.50N/AN/A7.177.42N/AN/A7.367.06N/AN/A
Flow-through7.557.20≤3.53≤3.537.187.30≤2.51≤2.516.587.33≤3.91≤3.91
Combined Wash6.305.87≤2.09≤2.095.755.87≤1.58≤1.585.535.25≤3.10≤3.08
Front Side≤3.433.19≤1.79≤1.79≤2.65≤2.65≤0.84≤0.84≤4.05≤3.05≤1.72≤1.70
Mainstream≤2.00≤2.00≤2.02≤2.02≤3.38≤3.35≤1.48≤1.66≤3.26≤3.26≤1.53≤1.53
Back Side≤3.36≤3.36≤3.55≤3.55≤3.48≤3.51≤1.72≤1.57≤3.42≤3.42≤2.09≤2.08
Hold ControlExp. A = 7.67 and Exp. B = 7.58Exp. A = 6.54 and Exp. B = 7.04Exp. A = 6.90 and Exp. B = 7.13
  • a XMuLV was only spiked into the Protein A load of the first runs.