Reference Standard Characterization Panel
-
Identity
- Intact mass – MS, LC-MS
- Peptide mapping – LC-MS/MS
- Western blot
- Chromatography
- N-terminal sequencing
-
Primary structure
- LC-MS/MS
-
Post-translational modifications
- Disulfide mapping – LC-MS/MS
- Glycan analysis (N- and O-linked)
- Oxidation – LC-MS/MS
- Deamidation – LC-MS/MS/Isoquant™
- N-terminus integrity – LC-MS/MS, N-terminal sequencing
- C-terminus integrity – LC-MS/MS, Carboxypeptidase sequencing
- Other PTMs – LC-MS/MS
-
Purity
- RP-HPLC
- IEX
- HIC
- SDS-PAGE
- CE-SDS
-
Charge distribution
- IEF
- cIEF
- Zone electrophoresis
- Imaging capillary elelctrophoresis (ICE)
-
Secondary structure
- CD
- FTIR
- ITF
-
Tertiary structure
- ITF/Extrinsic fluorescence
- DSC
-
Aggregation
- SEC
- SEC-MALLS
- AUC
- DLS
-
Potency
- Cell-based assay
- ELISA
- Binding – SPR (Biacore™)
-
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