Table 1.
Properties of polyclonal immune serum globulin products currently marketed in the United States
| Product | Manufacturer | IgG concentration | IgA concentration | Excipients | Viral safety |
|---|---|---|---|---|---|
| Products intended for intravenous use | |||||
| Carimmune NF | CSL-Behring | powdera | 0.72 mg/mL | sucrose | low pH, pepsin, 35 nm NF |
| Flebogamma DIF | Grifols | 5% | < 0.05 mg/mL | 50 mg/mL sorbitol; < 3 mg/mL PEG | pasteurization, S/D, 20 nm NF |
| Gammagard S/D | Baxter | powderb | < 2.2 μg/mL |
|
S/D |
| Gammagard Liq. | Baxter | 10% | 37 μg/mL | 250 mM glycine | pH 4, S/D, NF |
| Gamunex | Talecris | 10% | 46 μg/mL | 200 mM glycine | pH4, caprylate |
| Octagam | Octapharma | 5% | < 0.2 mg/mL | 10% maltose | S/D, pH 4 |
| Privigen | CSL-Behring | 10% | < 25 μg/mL | 250 mM L-proline | pH4, NF |
| Products intended for subcutaneous use | |||||
| Vivaglobin | CSL-Behring | 16% | < 1.7 mg/mL | 0.3 g/L NaCl | pasteurization |
| 250 mM glycine | fatty alcohol/low pH | ||||
| Products Intended for intramuscular use | |||||
| Gamastan | Talecris | 16% | NL | 300 mM glycine | S/D |
Abbreviations: NF, nanofiltered; NL, not listed; PEG, polyethylene glycol; S/D, solvent/detergent.
May be reconstituted to 3%, 6%, 9%, or 12% solution.
May be reconstituted to 5% or 10% solution. Data given for 5% solution.