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