Full
Outline
Therapeutic monoclonal antibody (mAb) drugs are highly homogeneous bio-macromolecules, with high degree of homogeneity in antigen epitopes, physical and chemical properties and biological activities, which can specifically bind to the target molecules. In the course of treatment, the incidence of adverse reactions is low while the tolerance of patients is high. Monoclonal antibodies are the focus in the field of bio-pharmaceutics, which have become the most important and fastest growing area in modern biopharmaceutical industry. According to the different production process and technology, the development of monoclonal antibodies has experienced four generations. Sintilimab injection, treprizumab injection, carrizumab for injection and tirizumab injection recently approved in China are all the third generation of humanized monoclonal antibody drugs. The molecular structure of monoclonal antibody drugs is complex, which is easy to change the heterogeneity of dimer, polymer and terminal amino acid mutation. These changes may cause serious effects on the safety and effectiveness of clinical medication. It is an important measure to control the quality of the original and finished products of monoclonal anti-tumor drugs to ensure the safety and effectiveness of such products. At present, the main methods of quality control and analysis of monoclonal antibody products include HPLC, ELISA, CZE, cIEF, iCIEF and CE-SDS. In this paper, the analysis methods for quality control and application status of monoclonal antibodies were reviewed, which can provide reference for related research and product quality control.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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