Product Information
Phase Detail
bioZen Intact XB-C8
bioZen Intact XB-C8 core-shell UHPLC columns provide extremely for impurity profiling and characterization of intact biologic fragments

bioZen Intact XB-C8

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.

Particle Size
3.6
Recommended Use
Fast separation of intact and subunit separation with hydrophobic selectivity

Minimize your priming with our BioTi™ Biocompatible hardware

Application ID 24717

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

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

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
13
 
% B
20
20
60
Flow Rate:
0.5 mL/min
Temperature:
80 °C
Detection:
UV @ 280 nm
Sample:
1. Infliximab F(ab)2

Cetuximab

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
13
 
% B
20
20
45
Flow Rate:
0.5 mL/min
Temperature:
80 °C
Detection:
UV @ 280 nm
Sample:
1. Cetuximab

Drug Antibody Ratio (DAR)

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.

Herceptin—vcMMAE using bioZen 3.6 µm Intact XB-C8

 

Herceptin—mcMMAF using bioZen 3.6 µm Intact XB-C8

scFc and F(ab’)2

Our bioZen Intact XB-C8 column shows improved peak shape and scFc detection.

Comparative separations may not be representative of all applications.
Conditions for all columns:

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
Detection:
UV @ 280 nm
Injection Volume:
1 µL
Sample:
Cetuximab

Heavy Chain, Light Chain Analysis

Observe excellent separation of heavy chain variants using the bioZen™ Intact XB-C8 column in your mAb intact fragment analysis.

Conditions for all columns:

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
Detection:
UV @ 280 nm
Injection Volume:
1 µL
Sample:
Cetuximab

Distilled Alcohol Standard by Neat Injection on GC-FID

Comparative separations may not be representative of all applications.
Conditions for all columns:

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
Detection:
UV @ 280 nm
Injection Volume:
1 µL
Sample:
1. Rituximab