Full
Outline
To develop quality control methods for recombinant anti-interleukin-23 monoclonal antibodies (anti-IL23 mAb).
Peptide map analysis by RP-HPLC was used for identification of an anti-IL-23 mAb. The purity was measured by reduced/non-reduced capillary electrophoresis-sodium dodecyl sulfonate (CE-SDS) and size exclusion-high performance liquid chromatography (SEC-HPLC). Charge heterogeneity was measured by imaging capillary isoelectric focusing electrophoresis (icIEF). LC isoAsp95 was measured by RP-HPLC. The biological activity was determined on U2OS IL23R/IL12RB1 dimerization cell. Other quality control items complied with corresponding requirements of “Chinese Pharmacopeia” 2015 edition and related guidelines.
Peptide mapping showed the specific spectrum of the anti-IL23 mAb, which could be adopted for the identification test. The area percentage of heavy chain, NGHC and light chain was (97.84±0.12)% as detected by reduced CE-SDS; the area percentage of main peak detected by non-reduced CE-SDS was (97.23±0.11)%. The area percentage of monomer peak and total aggregate peak detected by SEC-HPLC were (99.26±0.005)% and (0.71±0.005)%, respectively. The area percentage of main peak, acid peak and alkaline peak detected by icIEF were (73.83±0.29)%, (24.03±0.34)% and (2.10±0.09)%, respectively. The percentage of LC isoAsp95 was (3.37±0.52)%. The relative biological activity was (102.25±8.47)%.
A series of quality control methods for anti-IL23 mAbs has been established, which can be adaptable in ensuring the safety, effectiveness and quality controllability for similar biologics. The study is of great significance as a representative quality control reference for anti-IL23 mAbs.
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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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