PROTEIN IMPURITY ANALYSIS IN SECONDS

LabChip® GXII Touch Protein Clear™ HR Assay

Fast, High-resolution, Visible Peak Performance

Achieve greater confidence in your quality control processes from development to commercialization with the LabChip® GXII Touch Protein Clear™ HR assay.

The Protein Clear HR assay is designed for the high-resolution protein purity assessment of monoclonal antibodies (mAb) within research and development, enabling the detection and visualization of impurities within a sample, down to 5 ng/μL. With the analytical power and speed of the LabChip® GXII Touch system and IntelliChip™ assay optimization technology, you can accelerate your protein development workflows with unmatched throughput and reproducibility.

  • Detect and visualize impurity peaks in 65 seconds
  • Innovative IntelliChip technology provides intra- and inter-run reproducibility
  • Baseline resolution of proteins as close as 0.2%, determined by mass spectrometry
  • Limit of Detection (LOD) sensitivity of 5 ng/μL
  • 21 CFR 11 compatible for manufacturing and QC workflows

The LabChip® GXII Touch automated capillary electrophoresis platform delivers comparable results to traditional capillary electrophoresis with 46X faster run times without compromising sensitivity, resolution or reproducibility.

Labchip Protein Clear
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For research use only. Not for use in diagnostic procedures.

IntelliChip™ Assay Optimization Technology

The IntelliChip™ assay optimization technology automatically adjusts separation voltages and destain currents in real time to set optimal electrophoresis conditions for the sample plate, mitigating day-to-day variability, providing inter- and intra- run reproducibility in percent purity, and molecular weight sizing (Figure 1). A VeriMAb™ IgG standard is used during the calibration step as a reference standard to minimize the percent relative standard deviation (%RSD) for sizing and percent purity measurements.

Protein Clear
Figure 1. Overview of IntelliChip™ technology separation voltage and destaining currents adjusted in real-time.
Protein Clear
Figure 2. Protein Clear HR assay provides increased sensitivity and resolution to detect and visualize impurity peaks down to an LOD of 5 ng/μL. Inset electropherogram depicts complete run (65 seconds/ sample) of the Protein Clear HR assay for the non-reduced IgG mAb on the LabChip® GXII Touch instrument.
Protein Clear
Figure 3. Overlay of five independent runs demonstrating the IntelliChip™ assay optimization technology inter-run result reproducibility.

PROTEIN CLEAR HR ASSAY INTRA- & INTER-RUN REPRODUCIBILITY

Migration RSD Molecular Weight Sizing RSD Relative Percent Purity
IgG; non-reduced (main peak) Intra-run RSD
Intra-run RSD
1.31%
1.89%
0.41%
0.55%
0.14%
0.16%
IgG; reduced heavy chain Intra-run RSD
Intra-run RSD
1.29%
1.86%
0.42%
0.55%
3.08%
4.95%
IgG; reduced non-glysosylated heavy chain Intra-run RSD
Intra-run RSD
1.11%
1.66%
0.54%
0.69%
0.35%
1.81%
IgG; reduced light chain Intra-run RSD
Intra-run RSD
0.98%
1.51%
0.56%
0.98%
0.80%
4.51%
Summary <2.0% <2.0% <5.0%
Table 1. IntelliChipassay optimization technology provides intra- and inter-run molecular weight sizing reproducibility, reflected by minimal RSD for the reported migration, sizing and relative percent purity for a molecule. Samples were independently prepared by 3 different users using 5 different chips on 5 different instruments.

21 CFR Part 11 Compatible

The LabChip® GX Touch and Reviewer Software contains built-in technical controls and features specifically designed to be compatible with 21 CFR Part 11 requirements. These features include a shared user account database, access controls, device check, enforced sequencing of run steps, audit trails, record copying, record retention, system documentation, and electronic signature controls.

LabChip® Touch instruments generate data records in electronic form which are archived in a Central Data Repository. The LabChip® GX (GxP) Reviewer application can be run from any computer connected to the instrument network and allows modification and maintenance of the records with the ability to perform electronic signatures on the records generated from instruments in the lab system.

The robust and comprehensive LabChip® GXP Software uses secured, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records (Figure 5). In addition, unique combinations of user ID and password for electronic signature are used. Once locked, a record cannot be further modified without a separate signed unlock action (Figure 6).

Protein Clear
Figure 5. Audit Trails
Protein Clear
Figure 6. Perform Signature

System Requirements

Running of the Protein Clear assay requires a LabChip® GXII Touch instrument with V1.6 software or newer and Data Reviewer V5.4 or newer.

Kit Contents:

  • Protein Clear HR LabChip: CLS148695 for HT, CLS148696 for 24 (storage temperature 2-8 oC)
  • Protein Clear HR Dye (storage temperature -20 oC)
  • Protein Clear HR Sample Buffer (storage temperature 2-8 oC)
  • Protein Clear HR Gel Matrix (storage temperature 2-8 oC)
  • Protein Clear HR Ladder (storage temperature 2-8 oC)
  • Protein Clear HR Lower Marker(storage temperature 2-8 oC)
  • Protein Clear HR Wash Buffer (storage temperature 2-8 oC)
  • VeriMAb Standard (storage temperature 2-8 oC)

Key Specifications:

  • Sizing Range: 14-250 kDa
  • Linear Concentration Range: 10-1000 ng/μL (mAb, Non-reduced Main Peak)
  • Linearity (R2) :   >0.995
  • Sizing Resolution*: > 1.0 for VeriMAb Reference Standard
  • Sizing Precision RSD (CV): <2%   Maximum
  • Relative Migration Time Precision RSD (CV): <2%
  • Percent Purity Reproducibility: <0.5% Main Non-Reduced IgG; <5% All Other Peaks
  • Sensitivity (LOD): 5 ng/μL (mAb, Non-reduced Main Peak)
  • Separation Time per Sample: 65 Seconds
  • Maximum Sample Concentration: 2000 ng/μL
  • Number of Samples per Calibration: 96
  • Chip Lifetime: 400 Samples
  • Reagent Kit Primes: 10
  • Minimum Sample Volume: 2 μL

* Resolution is defined as the difference in migration times divided by the sum of the full width half max for two closely migrating peaks.

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