INCREASE SPEED, EFFICIENCY, & RELIABILITY OF CHARGE VARIANT ANALYSIS

LabChip® Charge Variant Analysis Assays

All biotherapeutic protein molecules come with charge heterogeneity sites, known as charge variants. Charge variants affect biological functions, such as binding and stability. Charge variant profiles also change dynamically throughout processes, such as sequence expression, chemical degradation, and post-translational modification. It is important to monitor and screen charge variant profiles of biotherapeutic proteins throughout development and manufacturing process. PerkinElmer’s LabChip® charge variant analysis assays are comparable to traditional CZE assays (Han, 2011) and can resolve and screen the charge variant profile of samples quickly, reliably, and automatically. With the throughput capability on the LabChip® GXII Touch™ protein characterization system, users can optimize their valuable research time to accelerate discovery and development of new biotherapeutic solutions.

Obtain Speed, Efficiency and of Charge Variant Analysis Throughout Biotherapeutic Development and Manufacturing Processes

  • Simple and automated operational workflow
  • Fast analysis speed: ~60 seconds per sample
  • High throughput: 96 samples per experiment
  • Minimal sample consumption: 25 μL
  • Full pI range coverage: pI 3 – 9, both acidic and basic proteins
  • Protein migration time can be adjusted based on running buffer pH
  • Good linearity: peak intensity proportional to variant concentration
  •  Reliable repeatability with C.V. < 2.5 %
Specifications
Sample Type Proteins
pl Range Low pl charge variant: 3.0-7.0
High pl charge variant: 7.0-9.5
Sample Volume 25 μl
Concentration 0.5-1.0 μg/μl (12.5-250 μg of total mAb)
Reproducibility C.V.<2.5% at constant concentration
Run Time 68, 90, 110 seconds per single sample
<3 hours for 96-well plate
Chip Lifetime 500 samples
Samples per Chip Prep 96 samples per chip prep
Samples per Reagent Kit 120 samples
Labchip CZE
Figure 1. Charge variant profile of a negative charged monoclonal antibody (mAb) on the LabChip® low pI charge variant assay. Due to a stronger electrophoretic force, acidic variants move toward the anode faster and arrive earlier at the detection window than main variants and basic variants. Acidic, main and basic variants are separated, resolved and labeled in the LabChip® charge variant assay. The relative concentration of each variant was also quantified.
Labchip CZE
Figure 2. Charge variant profile of a positive charged mAb on the LabChip® high pI charge variant assay. Due to a stronger electrophoretic force, basic variants move toward the cathode faster and arrive earlier at the detection window than main variants and acidic variants. Basic, main and acidic variants are separated, resolved and labeled in the LabChip® charge variant assay. The relative concentration of each variant was also quantified.
Labchip CZE
Figure 3. On LabChip® Low pI Charge Variant Assay, charge variant profiles of bovine serum albumin shift when pH of running buffer change from pH 5.6 to 7.2.
Labchip CZE
Figure 4. LabChip® Charge Variant Assays measure charge variant profile of protein reliably. Under pH =7.2 running buffer, charge variant profiles of bovine serum albumin exhibit same migration pattern. Migration time of main variant C.V. = 1.29% for tow repeatable runs.
Labchip CZE

Ordering Information

Assay Reagent Kit Labchip® HT
Labchip® Low pl Charge Variant Analysis CLS154134 CLS153418
Labchip® High pl Charge Variant Analysis CLS760670 CLS153419

Learn about other protein LabChip® assays designed to address your QC requirements:

Protein Assays

Reference:

Han, H., Livingston, E., and Chen, X. (2011) High Throughput Profiling of Charge Heterogeneity in Antibodies by Microchip Electrophoresis Anal. Chem. 83, 21, 8184–8191. doi.org/10.1021/ac201741w.
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For research use only. Not for use in diagnostic procedures.