Table 1.
Characterization of anti-SARS-CoV-2 IVIg formulations*.
| Type of plasma | ||||
|---|---|---|---|---|
| Vaccinated | Convalescent | Comercial Controla** | ||
| Plasma | Batch ID | 6700621DECHLF | 6650521DECHLF | CSL4340200191 |
| IgG (g/L) | 8.9 ± 0.3 | 10.8 ± 0.4 | – | |
| IgM (g/L) | 1.2 ± 0.0 | 1.4 ± 0.0 | – | |
| IgA (g/L) | 1.8 ± 0.1 | 2.0 ± 0.1 | – | |
| ID-NAT-HIV | Negative | Negative | – | |
| ID-NAT-HCV | Negative | Negative | – | |
| ID-NAT-HBV | Negative | Negative | – | |
| Final formulation | IgG (g/L) | 42.9 ± 3. | 52.8 ± 3.3 | 61.3 ± 1.9 |
| IgM (g/L) | 1.1 ± 0.1 | 3.8 ± 1.1 | 0.1 ± 0.0 | |
| IgA (g/L) | 6.6 ± 0.4 | 7.0 ± 0.1 | 0.3 ± 0.0 | |
| Anti-D antibodies | Negative | Negative | Negative | |
| Anti-A antibodies | 1/16 | 1/32 | 1/1 | |
| Anti-B antibodies | 1/16 | 1/8 | Negative | |
| Irregular antibodies | Negative | Negative | Negative | |
| pH | 7.0 | 7.0 | 6.5 | |
| Total protein (g/L) | 55.8 ± 0.3 | 69.2 ± 0.2 | 58.6 ± 0.1 | |
| Purity (%) | 84 | 86 | 100 | |
| Monomers (%) | 90.0% | 88.3% | 93.0 % | |
| Turbidity (NTU) | 23.3 ± 0.6 | 28.6 ± 0.8 | 66.3 ± 5.5 | |
| Osmolality (mOsm/kg) | 233.0 ± 1.0 | 228.0 ± 1.0 | 456.8 ± 2.9 | |
| PKA (IU/mL) | 2.4 ± 0.0 | <1.56 | <1.56 | |
| TGA thrombin (nM) | 144.5 ± 0.6 | 150.5 ± 26.4 | 139.6 ± 19.9 | |
| Sterility | No growth | No growth | No growth | |
| Endotoxin (EU/mL) | <4.2 EU/mL | <4.2 EU/mL | <4.2 EU/mL | |
| ID-NAT-HIV | Negative | Negative | Negative | |
| ID-NAT-HCV | Negative | Negative | Negative | |
| ID-NAT-HBV | Negative | Negative | Negative | |
| Process | Amount of plasma units | 101 | 158 | – |
| Plasma volume (L) | 20 | 32 | – | |
| Number of 40-mL vials | 39 | 48 | – | |
| Recovery (%) | 35 | 27 | – | |
| Yield (vials/L of plasma) | 2.0 | 1.5 | – | |
*
Results are presented as the average ± SD of a triplicate of determinations.
**
The commercial control is used as reference.