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To establish a method for determining the biological activity of adalimumab based on tumor necrosis factor-α (TNF-α) neutralization activity to provide technical means for parallel comparison of biological activities of similar biotherapeutic products of adalimumab.
The mouse fibroblast cell line L929 was used as target cell and the key reagents such as TNF-α and actinomycin D (Act-D) were standardized, then the experiment parameters including cell inoculation density, concentrations of key reagents, dilution gradient of adalimumab and incubation time were optimized. Then, the optimized method was validated by the methodology verification in the laboratory and the joint validation between laboratories to evaluate the performance of the method and its applicability to adalimumab reference products and similar biotherapeutic products.
There was a dose-response relationship between adalimumab concentrations and signal values in this method. The optimized concentrations of TNF-α and Act-D were 1 ng·mL-1 and 400 ng·mL-1 respectively, the optimized seeded cell number was 2×104 cells per well, the optimized initial antibody concentration was 1 000 ng·mL-1, the dilution ratio was 1∶2.5, and the optimized seeding time and incubation time were 18 h and 24 h. Methodological validation showed that this method was specific, reproducible and accurate. The results of joint validation were satisfactory.
This method is applicable to the five listed adalimumab products and can be used as a platform quality control method for the biological activity of adalimumab, which is convenient for the national sampling work and the parallel comparison between the products. It also provides an optional evaluation method for the establishment of national adalimumab standards and technical support for the inclusion of adalimumab monograph in Chinese Pharmacopoeia in the future.
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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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