|
Content |
Analysis |
Release |
Physical characteristics |
Appearance, Color, Clarity, Visible particulates, Subvisible particles, pH, Extractable Volume, Osmolality |
Identity |
Peptide Mapping, pI |
Content and Potency |
Protein Concentration, Potency |
Purity |
SEC, CE-SDS, Charge Variants, PAGE, WB |
Impurity and safety |
Bacterial endotoxin, Sterility, Microbial limit, Residual of HCP, HCD, Protein A/L |
Characterization |
Raw material and ingredients |
Identification by IR, HPLC-CAD, etc |
Primary structure |
LC-MS (MW, N/C-Terminal, Coverage, PTM, -S-S-, Variant), Glycans, AAA, free-thiol |
Higher-order structure |
DSF, IR, CD, Fluorescence |
Binding and Efficacy |
SPR, Octet, ELISA, FCM, Epitope binning or mapping |
Function |
Cell based assays, ADCC, CDC, Proliferation, apoptosis, phagocytosis etc. |