TABLE II

Estimated Amount of Antibody Needed To Neutralize a Viral Test Sample for Cell Culture and Animal Tests

Sample volume per cell line × cell types tested50 × 3 = 150 mL
Combined in vivo test sample volumes50 mL
Pretests and qualification sample volumes∼300 mL
Assumed virus titer in the seed lot/test sample108 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