Table 1. Properties and specifications (or range) of the IgG-enriched plasma fraction.
| Parameters | Results | Method |
|---|---|---|
| Formulation | Frozen | - |
| Appearance | Clear, bluish, no visible particles* | Visual observation |
| pH | 5.4–5.6* | pH meter |
| Na, mmol/L | 148.2 +/- 1.6* | Chemical analyzer |
| K, mmol/L | 2.4 +/- 0.1* | Chemical analyzer |
| Osmolality, mosm/kg | 295 +/- 15* | Osmometer |
| Total proteins, g/L | 60.5 ± 16.7** | Biuret |
| Gamma globulins, % | 90.2±2.8** | Zone electrophoresis |
| Immunoglobulin repartition | ||
| IgG, % | 83.2 ± 1.1** | Immunoturbidimetry |
| IgA, % | 12.4 ± 1.0** | Immunoturbidimetry |
| IgM, % | 4.4 ± 0.6** | Immunoturbidimetry |
| Albumin, g/L | < 3* | Bromocresol green |
| Aggregates, % | < 3* | HPLC |
| Monomers and dimers, % | > 90%* | HPLC |
| Anti-A/Anti-B, titer | < 1/32* | Micro-typing |
| Anti-HBs, mIU/mL (enrichment factor) | 330 +/- 421 (5.8 +/- 2.7)* | Architect, Abbott |
| Anti-rubella, mIU/ml (enrichment factor) | 322. 1 +/- 111.9 (4.1 +/- 1.3)* | Architect, Abbott |
| PKA, IU/mL (3% protein concentration) | 6.1 ± 1.1** | S-2302** |
| Thrombin generation, peak thrombin, nM | <350 (0–223)** | Technothrombin assay, RC high reagent |
| Plasmin, mU/mL | 26.3 ± 2.4** | S-2251 |
| Thrombin, mU/mL | 2.5 ± 2.4** | S-2238 |
| Thrombin-like activity, U/g | 0.011 ± 0.008** | S-2288 |
| Factor XIc IU/mL | < 0.01* | Coagulation assay |
| Factor XI/XIa Ag, ng/g protein | 2.4 ± 0.9** | Sandwich ELISA |
| Caprylic acid, μg/mL | < 750* | HPLC |
| DEHP, ppm | < 5* | HPLC |
| Endotoxin, EU/ml | < 0.5** | LAL test |
| Sterility | Pass* | Sterility test (growth medium) |
* N = 10;
** N = 5 (consecutive batches)