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Intact and Fragment Analysis
Impurity profiling and characterization of intact biologic fragments is a challenging undertaking because of the need to identify very small differences between variants. Both bioZen Intact columns contain skillfully manufactured large pore core-shell particles that provide narrower, taller peaks in conjunction with higher resolution between the target HC/LC, Fc/Fab, or isoforms.
Intact Trastuzumab at 70, 80, and 90°C
| Columns: |
| bioZen 1.8 μm SEC-3 |
| Dimension: |
| 150 x 4.6 mm |
| Mobile Phase: |
| 50 mM Dipotassium Phosphate + 100 mM Sodium Sulfate, pH 5.0 |
| Flow Rate: |
| 0.3 mL/min |
| Temperature: |
| Ambient |
| Detection: |
| UV @ 280 nm |
| Sample: |
| 1. γ-Globulin, 5 mg/mL 2. Ovalbumin, 1 mg/mL |
| Column: |
| bioZen 3.6 µm Intact XB-C8 |
| Dimension: |
| 00F-4766-AN |
| Part No.: |
| 150 x 2.1 mm |
| Mobile Phase: |
| A: 0.1 % TFA in Water B: 0.1 % TFA in Acetonitrile |
| Gradient: |
| Time (min) |
| 0 1 13 |
| % B |
| 20 20 45 |
| Flow Rate: |
| 0.5 mL/min |
| Temperature: |
| 70 °C 80 °C 90 °C |
| Detection: |
| UV @ 280 nm |
| Sample: |
| 1. Trastuzumab |
Infliximab F(ab)2
| Column: |
| bioZen 3.6 µm Intact XB-C8 |
| Dimension: |
| 150 x 2.1 mm |
| Part No.: |
| 00F-4766-AN |
| Mobile Phase: |
| A: 0.1 % TFA in Water B: 0.1 % TFA in Acetonitrile |
| Gradient: |
| Time (min) |
| 0 1 1 |