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Development of Identity Testing for Monoclonal Antibodies usingCapillary Isoelectric Focusing Method |
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| รหัสดีโอไอ | |
| Creator | 1. Titaporn Pootipinyowat 2. Wichuda Jariyapan 3. Saiwarul Jadoonkittinan 4. Teeranart Jivapaisarnpong |
| Title | Development of Identity Testing for Monoclonal Antibodies usingCapillary Isoelectric Focusing Method |
| Publisher | Faculty of Pharmaceutical Sciences KKU, MSU, UBU |
| Publication Year | 2558 |
| Journal Title | Isan Journal ofPharmaceutical Sciences |
| Journal Vol. | 11 |
| Journal No. | 2 |
| Page no. | 45-54 |
| Keyword | capillary isoelectric focusing,monoclonal antibodies,isoelectric point,isoforms |
| ISSN | 19050852 |
| Abstract | Introduction: Currently, many monoclonal antibodies produced by biotechnology are imported to Thailand. As protein drugs, their manufacturing process are complex; if quality control is inadequately performed, the drugs' quality would be inconsistent. When isoforms occur, they may affect drug effi cacy and safety. Therefore, capillary isoelectric focusing (cIEF) was developed as identity testing based on isoelectric point (pI) differences of protein molecules. Methods: Validation of cIEF using PA 800 Beckman Coulter was performed and protein drugs; monoclonal antibody including granulocyte colony stimulating factor were used. Results: The validated conditions offered good separation of monoclonal antibodies from peptide markers, their specifi c pIs were shown. The results of both repeatability and reproducibility were precise; percent relative standard deviation (%RSD) for pIs of the main peaks was less than 0.3. |
