| Type | CQA |
|---|---|
| Regular test | Appearance |
| Regular test | PH |
| Regular test | Osmolality |
| Regular test | Volume |
| Characterization | Morphology |
| Characterization | Particle size |
| Characterization | Physical concentration |
| Characterization | Total protein |
| Characterization | Purity |
| Characterization | Positive marker proteins |
| Characterization | Negative marker protein (Calnexin) |
| Impurity |
HCD
|
| Impurity |
Size distribution of residual DNA
|
| Impurity | HCP |
| Impurity |
Residual benzonase
|
| Safety control test | Sterility |
| Safety control test | Endotoxin |
| Safety control test | Mycoplasma |
| Safety control test | Adventitious agents |
| Safety control test | EOPC identification |




