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 |