|
项目 |
检项 |
放行 |
物理特性 |
Appearance, Colour, Clarity,Visible particulates,Subvisible particles, pH, Extractable Volume, Osmolality
|
鉴别 |
Peptide Mapping, pI |
含量和活性 |
Protein Concentration, Potency |
纯度 |
SEC,CE-SDS, Charge Variants, PAGE, WB |
杂质和安全 |
Bacterial endotoxin, Sterility, Microbial limit, Residual of HCP, HCD, Protein A or Protein L |
表征 |
原辅料鉴别 |
ldentification by IR, HPLC-CAD, etc |
一级结构 |
LC-MS (MW,N/C-Terminal, Coverage, PTM,-S-S-,Variant), Glycans,AAA, free-thiol |
高级结构 |
DSF, IR, CD, Fluorescence |
分子结合 |
SPR, Octet, ELISA, FCM, Epitope binning or mapping |
细胞功能 |
Cell based assays, ADCC, CDC, Proliferation, Apoptosis, Phagocytosis etc. |