Table 2.
Aggregates Quantification Results by SEC
| Soluble Species (%)b |
||||
|---|---|---|---|---|
| Sample | Insoluble Aggregates (%)a | Monomer | Dimer | Higher-Order Aggregates |
| Abatacept | ||||
| PBS | ||||
| Control | <1 | 98.5 ± 0.1 | 1.5 ± 0.1 | − |
| Polymer-SOF | 2 | 98.4 ± 0.0 | 1.6 ± 0.0 | − |
| Glass-SOF | 2 | 98.4 ± 0.1 | 1.6 ± 0.1 | − |
| Polymer-so+ | 5 | 97.5 ± 0.3 | 1.6 ± 0.1 | 0.9 ± 0.1 |
| Glass-so+ | 7 | 91.4 ± 0.0 | 3.8 ± 0.0 | 4.8 ± 0.0 |
| Acetate Buffer | ||||
| Control | 4 | 93.2 ± 0.0 | 6.8 ± 0.0 | − |
| Polymer-SOF | 4 | 88.5 ± 0.0 | 11.5 ± 0.0 | − |
| Glass-SOF | 4 | 90.9 ± 0.0 | 9.1 ± 0.0 | − |
| Polymer-so+ | 14 | 89.3 ± 0.1 | 10.7 ± 0.1 | − |
| Glass-so+ | 19 | 92.6 ± 0.0 | 7.4 ± 0.1 | − |
| Adalimumab | ||||
| PBS | ||||
| Control | <1 | 100.0 ± 0.0 | − | − |
| Polymer-SOF | <1 | 100.0 ± 0.0 | − | − |
| Glass-SOF | <1 | 99.9 ± 0.1 | 0.1 ± 0.1 | − |
| Polymer-so+ | <1 | 99.9 ± 0.1 | 0.1 ± 0.1 | − |
| Glass-so+ | 15 | 99.1 ± 0.1 | 0.5 ± 0.1 | 0.4 ± 0.1 |
| Acetate Buffer | ||||
| Control | <1 | 100.0 ± 0.0 | − | − |
| Polymer-SOF | <1 | 100.0 ± 0.0 | − | − |
| Glass-SOF | <1 | 100.0 ± 0.0 | − | − |
| Polymer-so+ | <1 | 100.0 ± 0.0 | − | − |
| Glass-so+ | <1 | 99.3 ± 0.1 | 0.4 ± 0.0 | 0.3 ± 0.1 |
a
Stressed samples were centrifuged for 30 min at 15,600g, and percent insoluble aggregation was determined from the difference of A280 before and after centrifugation, taken as a percentage of the A280 present before centrifugation.
b
Data are shown as the average of three measurements ± standard deviation.