FAST AND RELIABLE AUTOMATED QC SOLUTION FOR BIOTHERAPEUTICS

LabChip^® GXII Touch^™ Protein Characterization System

The LabChip^® GXII Touch^™ protein characterization system offers an automated alternative to traditional methods by streamlining slab gel electrophoresis, while also providing the increased throughput and data quality required by biotherapeutics and genomics workflows. This flexible instrument supports multiple assays for characterizing both proteins and nucleic acids.

With the LabChip^® GXII Touch^™ protein characterization system, analysis can be performed in as few as 42 seconds per sample, delivering data comparable to data obtained using traditional capillary electrophoresis with as much as a 70X increase in throughput. Choose between two platforms for the greatest efficiency: a high-throughput (up to 384 samples) or lower throughput platform depending upon workflow requirements. With an easy-to-use touch screen interface, even novice users can run samples quickly.

Protein Assays

Nucleic Acid Assays

LabChip^® GXII Touch^™ Instrument Screen Simplifies Sample Analysis

User friendly operation

• Load sample plate and chip
• Select samples (up to 384 in a run)
• Select assay type
• Touch ‘Run’ to start
• Automatically export data directly to your network or LIMS system

Observe runs in real time

• Sample analysis in as few as 42 seconds
• View electropherogram in real time during data collection
• Overlay collected data to compare sample profiles
• Select from various run time analytical feature annotations

See data in real time or export for later analysis

• Choose “display” in E-gram, virtual gel, or data table format (Figure 1)
• Pull multiple archived plates into data review or analytical comparisons
• Apply data mining filter functions on key attributes
• Highlight expected peaks
• Track relevant user access and data history parameters with FDA 21 CFR Part 11 compatible software

The LabChip^® GXII Touch^™ protein characterization system operator controls are designed to allow users to easily set up and execute a run in as few as three easy steps (Figure 3). Run templates can also be imported with the operator control features. Run templates can include well selections, sample names, peak tables, which facilitate operator ease of use, and data can be automatically exported to network or LIMS directories for subsequent analysis.
Every instrument comes with a full software package for data review, allowing analysis from current or archived data sets. LabChip^® GXII Touch^™ and Reviewer Software contain built-in technical controls and features specifically designed to support FDA 21 CFR Part 11 regulations. 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.

The LabChip^® GXII Touch^™ protein characterization system offers rapid quantification and quality control throughout biotherapeutics and genomic workflows. For example, automating the characterization process allows multiple, critical quality attributes to be obtained significantly faster. Researchers can now screen for optimal protein characteristics earlier in the process and integrate Quality by Design initiatives into their biotherapeutics development workflow (Figure 7).

LabChip^® Electrophoresis: How Does it Work?

LabChip^® electrophoresis is performed on a small, microfluidic chip. Prior to analysis, reagents are loaded into the individual wells of the chip. These wells are connected to tiny microchannels about the size of a human hair etched within the quartz microfluidic chip. When the chip is loaded into the LabChip^® GXII Touch^™ protein characterization system, the chip’s wells interface with platinum electrodes that provide voltage and current control. The instrument moves the microtiter plate directly under the chip’s capillary ‘sipper’, and approximately 150 nL of sample is aspirated onto the chip. Sample staining and destaining are performed automatically on the instrument platform. Individual sample analytes are separated electrophoretically and the bands detected via laser induced fluorescence in the capillaries of the chip. Sizing and concentration for each band are determined using ladder and internal markers. Rinsing the sipper between samples minimizes cross contamination.