Full
Outline
To validate the applicability of a residual CHO host cell protein (HCP) test method for the in-process candidate therapeutic monoclonal antibody and its release control.
The coverage ratio of goat anti-CHO HCP polyclonal antibody to the HCPs from supernatant of fermented mock CHO cells was determined by fluorescent-labeled two-dimensional differential gel electrophoresis (2D-DIGE). The limit of detection (LOD) and limit of quantitation (LOQ) were determined statistically from results of 40 tests. The specificity, precision/intermediate precision, accuracy, linearity and robustness were validated according to ICH Q2. To verify the suitability of the method for in-process quality control, key HCP removal steps, and sample dilution ranges for each step were determined according to USP 〈1132〉.
The coverage ratio of goat anti-CHO HCP polyclonal antibody was 56%. The LOD and LOQ was 2.47 and 7.41 ng·mL-1, respectively. The validation results showed that the specificity, repeatability/intermediate precision, accuracy, linearity and robustness of the selected CHO HCP test method all met the application requirements. With the detection results of serially diluted purification intermediates, the dilution factor range of intermediates and HCP clearance ratio of each purification step was confirmed, and protein A affinity chromatography was identified as the main clearance step for HCP. Deduced with the above results, the selected CHO HCP test method can be used as the in-process control method for protein A chromatography and release test for drug substance.
The selected CHO HCP test method can be used in the process control and drug substance release of candidate therapeutic 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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