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To explore the correlations between opalescence and molecular size, purity or aggregation tendency in the antibody formulation.
Studied on the opalescence phenomena of various antibodies, including the influence of different concentrations, pH/buffer, excipients, as well as the influence of environmental factors such as temperature, light, freeze-thaw and agitation, and the correlations had been analyzed between opalescence and molecular size, purity (aggregation), KD or Tagg.
The degree of antibody opalescence was positively correlated with the molecular size, the deepening of the opalescence indicated that the molecular size was increased and the more tendency of molecular aggregation. For example, the opalescence of C molecule obviously enhanced under high temperature, and the result of turbidity changed from 3.3 NTU to 13.6 NTU, the molecular size changed from 13.1 nm to 40.6 nm, and the KD changed from positive to negative. The Tagg changed from 59.6 ℃ to below 50 ℃.
The opalescence can be affected by buffer system, pH, excipients and ambient temperature, the degree of opalescence increased, indicating the stability become worse and the molecules prone to aggregate. This study provides important reference for the analysis and evaluation of opalescence in the antibody formulation development.
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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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