Alternate Virus-Spiking Strategies Viral Clearance Study Design (*Calculations Based on an Estimated Virus Starting Titer of 8.4 log10TCID50/mL)
| Run | Spike 1 | Spike 2 | Spike 3 | Total | ||||
|---|---|---|---|---|---|---|---|---|
| mAb Volume (mL) | % Spike Total | mAb Volume (mL) | % Spike total | mAb Volume (mL) | % Spike Total | Stock Virus Volume (mL) | Estimated Total Virus Load (log10 TCID50)* | |
| Control-high spike | 720 | 1% | (N/A) | 7.2 | 9.3 | |||
| Control-low spike | 720 | 0.01% | (N/A) | 0.1 | 7.3 | |||
| Bracketed | 30 | 0.5% | Protein-only (660 mL) | 30 | 0.5% | 0.3 | 7.9 | |
| Variable bracketed | 30 | 0.5% | 660 | 0.003% | 30 | 0.5% | 0.3 | 7.9 |