Table 3.
Viral Reduction Treatments of Licensed Plasma Products
| Treatment | Products | Target viruses in-process treatment | Comments |
|---|---|---|---|
| In-process treatment | |||
| Solvent-detergent | Coagulation factors (eg, FVIII, prothrombin complex, FIX, VWF, fibrinogen) | E | No, or limited, protein denaturation |
| AT | The SD agents are removed by subsequent protein purification steps | ||
| IgG | |||
| Fibrin sealants | |||
| Pasteurization | Coagulation factors (eg, FVIII, fibrinogen) | E | Protein stabilizers may limit viral inactivation |
| IgG | Most NE | B19 is heat resistant | |
| AAT | 10% to 30% loss of functional activity of coagulation factors | ||
| AT | |||
| Vapor heat | Coagulation factors (eg, FVIII) | E | |
| C1-inh | Most NE | As pasteurization | |
| Fibrin sealants | |||
| Low pH (pH 4) treatment | IgG | E | Most other plasma proteins loose functional activity at low pH |
| Caprylic acid treatment (<pH 5.5) | IgG and IgM | pH 4 sensitive NE | Most other plasma proteins loose functional activity at low pH |
| E | |||
| Nanofiltration | E | ||
| Coagulation factors (eg, FIX, FXI, FVIII, VWF) | NE | Viral removal by size-exclusion mechanism depends upon virus size and shape, and nanofilter porosity | |
| IgG | |||
| AAT | |||
| AT | |||
| Fibrin sealant | |||
| Terminal treatment | |||
| Pasteurization | Albumin | E | Only for a product withstanding liquid heat-treatment in the presence of small amount of stabilizers |
| NE | |||
| Dry heat | Coagulation factors (eg, FVIII, FIX, prothrombin complex, FXI) | Some E | Inactivation of heat-resistant viruses depends on temperature and duration |
| Some NE | Hardly inactivates B19 | ||
| 10% to 20% loss of functional activity of coagulation factors | |||
E indicates enveloped; NE, nonenveloped.