Sample volume per cell line × cell types tested | 50 × 3 = 150 mL |
Combined in vivo test sample volumes | 50 mL |
Pretests and qualification sample volumes | ∼300 mL |
Assumed virus titer in the seed lot/test sample | 108 TCID50/mL |
Total virus titer to be neutralized (108 × 500) | 1010.7 TCID50 |
Assumed neutralizing serum titer (dilution of a potent serum neutralizing ∼102 TCID50 of virus by 50% in a mixture of 100 μL virus with 100 μL serum dilution) | 1:20000–1:40000 |
50% neutralizing capacity of 1 mL undiluted serum (102 TCID50 × 10 × 104.3 or 104.6) | 107.3–107.6 TCID50 |
Assumed minimum overage to achieve 100% neutralization | × 2 |
Amount of serum neutralizing 1010.7 TCID50 by 100% | 2518–5024 mL |