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Characteristics of the simulated IVIG
| Source plasma | Number of trials | Purity (%) | Monomer plus dimer (%) | ACA (%) | PKA (IU/mL) | TnBP (µg/mL) | Triton X‐100 (µg/mL) | Yield (g/L) | Titer recovery (%) |
|---|---|---|---|---|---|---|---|---|---|
| Normal | 4 | 98.9 ± 0.3 | 100 | 25 ± 10 | <9.3 | NT* | NT | 3.8 ± 0.5 | NA† |
| Hepatitis B hyperimmune | 4 | 99.0 ± 0.2 | 100 | 23 ± 11 | <9.3 | <2 | <5 | 4.0 ± 0.3 | 48.5 ± 8.0 |
NT = not tested.
NA = not applicable.
