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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
Column: | 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 |
Gradient: | 20-50 % in 5 min |
Flow Rate: | 0.3 mL/min |
Temperature: | Ambient |
Detection | UV @ 280 nm |
Sample:
Column: | bioZen 2.6 µm WidePore C4 |
Dimension | 100 x 2.1 mm |
Part No.: | 00D-4786-AN |
Mobile Phase: | A: 0.1 % Formic acic in Water, B: 0.1 % Formic acic in Acetonitrile |
Gradient: | 10-90 % B in 4 minutes |
Flow Rate: | 0.3 mL/min |
Temperature: | 80 °C |
Detection | UV @ 280 nm |
Sample:
mAbs, Various (1 mg/mL)
Improved peak shape for intact mass applications by high resolution MS.
Sample | Retention Time | Width @ 50% |
|---|---|---|
| Rituximab | 3.580 | 0.0233 |
| Infliximab Biosimilar | 3.606 | 0.0272 |
| Cetuximab | 3.696 | 0.0270 |
| Infliximab | 3.615 | 0.0222 |
Column: | bioZen 2.6 µm WidePore C4 |
Dimension | 100 x 2.1 mm |
Part No.: | 00D-4786-AN |
Mobile Phase: | A: 0.1 % Formic acic in Water, B: 0.1 % Formic acic in Acetonitrile |
Gradient: | 10-90 % B in 4 minutes |
Flow Rate: | 0.3 mL/min |
Temperature: | 80 °C |
Detection | UV @ 280 nm |
Sample:
Infliximab (1 mg/mL)
DTT-reduced NIST mAb (1 mg/mL)
Column: | bioZen 2.6 µm WidePore C4 |
Dimension | 100 x 2.1 mm |
Part No.: | 00D-4786-AN |
Mobile Phase: | A: 0.1 % Formic acic in Water, B: 0.1 % Formic acic in Acetonitrile |
Gradient: | 10-90 % B in 4 minutes |
Flow Rate: | 0.3 mL/min |
Temperature: | 80 °C |
Detection | UV @ 280 nm |
Sample:
Infliximab (1 mg/mL)
DTT-reduced NIST mAb (1 mg/mL)
Column: | bioZen 2.6 µm WidePore C4 |
Dimension | 100 x 2.1 mm |
Part No.: | 00D-4786-AN |
Mobile Phase: | A: 0.1 % Formic acic in Water, B: 0.1 % Formic acic in Acetonitrile |
Gradient: | 10-90 % B in 4 minutes |
Flow Rate: | 0.3 mL/min |
Temperature: | 80 °C |
Detection | UV @ 280 nm |
