Protein Clear HR Reagent Kit

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.

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.

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).

Figure 3. Audit Trails

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.

Protein clear HR assay specifications