TABLE IV

Alternate Virus-Spiking Strategies Viral Clearance Study Results (*Based on Average of Bracketed Spikes (within 1 log)

RunSpike 1Spike 2Spike 3Totals
mAb Volume (mL)Log Reduction Value (LRV)mAb Volume (mL)LRVmAb Volume (mL)LRVEstimated Total Viral Load (log10 TCID)*LRV
Control-high spike734≥5.94(N/A)8.48≥5.94
Control-low spike726≥3.64(N/A)6.17≥3.64
Bracketed30≥6.05Protein Only (670 mL)30≥5.107.20≥5.80*
Variable bracketed30≥5.04665≥4.0630≥4.986.79≥5.94*