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.
Columns:
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Dimension:
150 x 4.6 mm
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Mobile Phase:
50 mM Dipotassium Phosphate + 100 mM
Sodium Sulfate, pH 5.0
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Flow Rate:
0.3 mL/min
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Temperature:
Ambient
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Detection:
UV @ 280 nm
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Sample:
1. γ-Globulin, 5 mg/mL
2. Ovalbumin, 1 mg/mL |
Column:
bioZen 3.6 µm Intact XB-C8
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Dimension:
00F-4766-AN
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Part No.:
150 x 2.1 mm
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Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
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Gradient:
Time (min)
0
1 13 |
% B
20
20 45 |
Flow Rate:
0.5 mL/min
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Temperature:
70 °C
80 °C 90 °C |
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Detection:
UV @ 280 nm
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Sample:
1. Trastuzumab
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Column:
bioZen 3.6 µm Intact XB-C8
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Dimension:
150 x 2.1 mm
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Part No.:
00F-4766-AN
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Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
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Gradient:
Time (min)
0
1 13 |
% B
20
20 60 |
Flow Rate:
0.5 mL/min
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Temperature:
80 °C
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Detection:
UV @ 280 nm
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Sample:
1. Infliximab F(ab)2
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Column:
bioZen 3.6 µm Intact XB-C8
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Dimension:
150 x 2.1  mm
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Part No.:
00F-4766-AN
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Mobile Phase:
A: 0.1 % TFA in Water B: 0.1 % TFA in Acetonitrile |
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Gradient:
Time (min)
0
1 13 | % B
20 20 45 |
Flow Rate:
0.5 mL/min |
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Temperature:
80 °C |
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Detection:
UV @ 280 nm |
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Sample:
1. Cetuximab |
With a direct effect on efficacy and safety, conjugation for each ADC must be well understood. The bioZen Intact XB-C8 provides an excellent vehicle for determining drug load distribution and DAR for ADCs. Its large pore size allows intact ADCs to interact with a moderately retentive stationary phase while the core-shell particle supplies increased efficiency to deliver the required resolution between ADC species with differing drug loads.
Columns:
bioZen 3.6 μm Intact XB-C8
Agilent 3.5 μm AdvanceBio RP-mAb SB-C8 |
Dimension:
150 x 2.1  mm
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Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
20-45 %  B in 12 minutes
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Flow Rate:
0.5 mL/min
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Temperature:
80 °C
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Detection:
UV @ 280 nm
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Injection Volume:
1 µL
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Sample:
Cetuximab
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Columns:
bioZen 3.6 μm Intact XB-C8
Agilent 3.5 μm AdvanceBio RP-mAb SB-C8 |
Dimension:
150 x 2.1  mm
|
Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
20-45 %  B in 12 minutes
|
Flow Rate:
0.5 mL/min
|
Temperature:
80 °C
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Detection:
UV @ 280 nm
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Injection Volume:
1 µL
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Sample:
Cetuximab
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Columns:
bioZen 3.6 μm Intact XB-C8
Agilent 3.5 μm AdvanceBio RP-mAb SB-C8 |
Dimension:
150 x 2.1  mm
|
Mobile Phase:
A: 0.1 % TFA in Water
B: 0.1 % TFA in Acetonitrile |
Gradient:
20-45 %  B in 12 minutes
|
Flow Rate:
0.5 mL/min
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Temperature:
80 °C
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Detection:
UV @ 280 nm
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Injection Volume:
1 µL
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Sample:
1. Rituximab
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