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
Separation Mode Reversed Phase |
Particle Size 2.6 |
Recommended Use Optimal particle and pore size morphology for high reproducibility and resolution for intact and subunit analysis |
Columns:
|
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 |
Columns:
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 (min) |
Width @ 50% |
---|---|---|
Rituximab | 3.580 | 0.0233 |
Infliximab Biosimilar | 3.606 | 0.0272 |
Cetuximab | 3.696 | 0.0270 |
Infliximab | 3.615 | 0.0222 |
Columns:
bioZen 2.6 µm WidePore C4
|
Dimension:
100 x 2.1 mm
|
Part No.:
00D-4786-AN
|
Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
20-55 % B in 6 minutes (Intact)
25-45 % B in 6 minutes (Subunit) |
Flow Rate:
0.5 mL/min
|
Temperature:
As Indicated
|
Detection:
UV @ 280 nm (Intact)
UV @ 214 nm (Subunit) |
Sample:
Infliximab (1 mg/mL)
DTT-reduced NIST mAb (1 mg/mL) |
Columns:
bioZen 2.6 µm WidePore C4
|
Dimension:
100 x 2.1 mm
|
Part No.:
00D-4786-AN
|
Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
25-45 % B in 6 minutes
|
Flow Rate:
As indicated
|
Temperature:
90 °C
|
Detection:
UV @ 280 nm (Intact)
UV @ 214 nm (Subunit) |
Injection Volume:
2 µL
|
Sample:
NIST mAb (1 mg/mL)
DTT-reduced NIST mAb (1 mg/mL) |
Columns:
bioZen 2.6 µm WidePore C4
|
Dimension:
100 x 2.1 mm
|
Part No.:
00D-4786-AN
|
Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
As indicated
|
Flow Rate:
0.5 mL/min
|
Temperature:
90 °C
|
Detection:
UV @ 280 nm (Intact)
UV @ 214 nm (Subunit) |
Injection Volume:
2 µL
|
Sample:
DTT-reduced NIST mAb (1 mg/mL)
|