Reference Standard Characterization Panel
-
Identity
- Western blot
- Chromatography
-
Purity
- RP-HPLC
- IEX
- HIC
- SDS-PAGE
- CE-SDS
-
Charge distribution
- IEF
- cIEF
- Zone electrophoresis
- Imaging capillary elelctrophoresis (ICE)
-
Aggregation
- SEC
- AUC
- DLS
-
Potency
- Cell-based assay
- ELISA
-
Strength
- AAA
- Absorbance at 280nm
- Extinction coefficient by AAA
- Colorimetric – Bradford/Lowry
-
Physiochemical
- Appearance
- pH
- Osmolality
-
Biosafety
- Endotoxin
- Bioburden
- Sterility
-
Other impurities
- Residual DNA
- Residual HCP
- Residual process impurities