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Protein Clear HR Reagent Kit

The LabChip® GXII Touch 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.

For research use only. Not for use in diagnostic procedures.

Part number: CLS960014
List price: USD 831.86
Your price:
USD 831.86
USD 831.86 /each


Protein Impurity Analysis in seconds

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

Additional product information

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.

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. 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 HR LabChip Touch HT

Figure 1. 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 HR LabChip Touch HT

Figure 2. Overlay of five independent runs demonstrating the IntelliChip assay optimization technology inter-run result reproducibility.

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 3). 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 4).

Protein Clear HR LabChip Touch HT

Figure 3. Audit Trails

Protein Clear HR LabChip Touch HT

Figure 4. 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.

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.


Analytical Technique
Protein Analysis & Detection
Protein Analysis
LabChip GXII
Research Areas
Drug Development & Manufacturing
Drug Discovery & Manufacturing
Food & Agriculture
Sample Type
Shipping Conditions
Shipped in Dry Ice


Protein clear HR assay specifications
Parameter Specification
Sizing range 14-250 kDa
Maximum sample concentration 2000 ng/μL
Sizing resolution* Resolution > 1.0 for VeriMAb reference standard
Sizing precision RSD (CV) <2%
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)
Linear concentration range 10 – 1000 ng/ μL (mAb, non-reduced main peak)
Linearity (R^2) >0.995
Separation time per sample 65 seconds
Maximum number of samples per calibration 96
Chip lifetime  400 samples
Reagent kit primes 10
Minimum sample volume 2 μL



1-3 of 3 Resources
Application Note Icon
Application Note
An evaluation of control analysis system performance between the LabChip GXII and SCIEX PA800 Plus system

In this application note mAbs were evaluated using both the Protein Clear HR assay and an orthogonal method, the SCIEX® PA800...

Product Note Icon
Product Note
Automated characterization of proteins and nucleic acids

Read the LabChip® GXII Touch protein characterization system product note to learn about an automated alternative to traditional...

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Application Note
Characterization of NISTmAb with microfluidic CE-SDS

Capillary electrophoresis (CE), more specifically CE-SDS, is becoming an increasingly popular and routinely used method for...

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