| |
項目 |
檢項 |
| 放行 |
物理特性 |
Appearance, Colour, Clarity,Visible particulates,Subvisible particles, pH, Extractable Volume, Osmolality
|
| 鑒別 |
Peptide Mapping, pI |
| 含量和活性 |
Protein Concentration, Potency |
| 純度 |
SEC,CE-SDS, Charge Variants, PAGE, WB |
| 雜質和安全 |
Bacterial endotoxin, Sterility, Microbial limit, Residual of HCP, HCD, Protein A or Protein L |
| 表征 |
原輔料鑒別 |
ldentification by IR, HPLC-CAD, etc |
| 一級結構 |
LC-MS (MW,N/C-Terminal, Coverage, PTM,-S-S-,Variant), Glycans,AAA, free-thiol |
| 高級結構 |
DSF, IR, CD, Fluorescence |
| 分子結合 |
SPR, Octet, ELISA, FCM, Epitope binning or mapping |
| 細胞功能 |
Cell based assays, ADCC, CDC, Proliferation, Apoptosis, Phagocytosis etc. |