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

- PICO PROTEIN ASSAY
- PROTEIN LOW MOLECULAR WEIGHT ASSAY
- EXTENDED RANGE N-GLYCAN ASSAY
- GLYCAN PROFILING ASSAY
- PROTEIN CHARGE VARIANT ASSAY
- PROTEIN EXPRESS ASSAY
- PROTEIN CLEAR™ ASSAY
- PROTEINEXACT™ ASSAY
Nucleic Acid Assays

- DNA 1K ASSAY
- DNA 5K ASSAY
- DNA 12K ASSAY
- DNA HIGH SENSITIVITY ASSAY
- GENOMIC DNA ASSAY
- NGS 3K ASSAY
- STANDARD RNA ASSAY
- PICO RNA ASSAY
- SMALL RNA ASSAY
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).

Figure 1. The LabChip® GXII Touch™ protein characterization system interface offers real-time run data output and complete sample analysis.

Figure 2.Software complies with FDA 21CFR Part 11 regulations.

Figure 3. RNA Pico assay

Figure 4. Glycan Screening assay

Figure 5. Protein Charge Variant assay

Figure 6. Protein Clear HR™ assay for impurity analysis

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.

Independent Analysis of LabChip® GXII Touch™ protein characterization system and assays for DoE development to assess critical parameters that assess mAb purity
Smith, M. T., Zhang, S., Adams, T., Dipaolo, B., & Dally, J. (2017). Establishment and validation of a microfluidic capillary gel electrophoresis platform method for purity analysis of therapeutic monoclonal antibodies. Electrophoresis,38(9-10), 1353-1365. doi:10.1002/elps.201600519
21CFR Part 11 Compatible Software is available with the LabChip® GXII Touch™ protein characterization system
To assist in your compliance planning, LabChip® GxP Security Software is available which allows the LabChip® GXII Touch™ protein characterization system to run in an environment consistent with CFR21 Part 11 compliance and validation. This includes access security, data security and verification, and a complete set of audit logging functionality. Please contact your local representative for more information.
Dimensions:
Height | Width | Depth | Weight | Plate Formats | Power Requirements | Power Consumption | Excitation/Emmission | Temperature Range | Humidity Range |
---|---|---|---|---|---|---|---|---|---|
25.75 | 19.25 | 18.25 | 54 lbs (24.5 kg) | 96- or 384-well | 100-240 Vac | N/A | 635 and 700 nm | 18-26°C | 20% - 80% RH |
Windows 10-compatible software
Accurate Sizing, Quantification and Quality Control of Proteins
Cao, J., Perez-Pinera, P., Lowenhaupt, K., Wu, M., Purcell, O., Fuente-Nunez, C. D., & Lu, T. K. (2018). Versatile and on-demand biologics co-production in yeast. Nature Communications, 9(1). doi:10.1038/s41467-017-02587-w.
Reardon, H. T., Herbst, R. A., Henry, C. L., Herbst, D. M., Ngo, N., Cisar, J. S., . . . O’Neill, G. P. (2019). Quantification of In Vivo Target Engagement Using Microfluidic Activity-Based Protein Profiling. SLAS TECHNOLOGY: Translating Life Sciences Innovation,247263031985230. doi:10.1177/2472630319852303
Regula, J. T., Imhof-Jung, S., Mølhøj, M., Benz, J., Ehler, A., Bujotzek, A., . . . Klein, C. (2018). Variable heavy–variable light domain and Fab-arm CrossMabs with charged residue exchanges to enforce correct light chain assembly. Protein Engineering, Design and Selection,31(7-8), 289-299. doi:10.1093/protein/gzy021.
Smith, M. T., Zhang, S., Adams, T., Dipaolo, B., & Dally, J. (2017). Establishment and validation of a microfluidic capillary gel electrophoresis platform method for purity analysis of therapeutic monoclonal antibodies. Electrophoresis,38(9-10), 1353-1365. doi:10.1002/elps.201600519
Smith, M. T., Zhang, S., Adams, T., Dipaolo, B., & Dally, J. (2017). Establishment and validation of a microfluidic capillary gel electrophoresis platform method for purity analysis of therapeutic monoclonal antibodies. Electrophoresis,38(9-10), 1353-1365. doi:10.1002/elps.201600519.
Weng, Y., Ishino, T., Sievers, A., Talukdar, S., Chabot, J. R., Tam, A., . . . Lin, L. (2018). Glyco-engineered Long Acting FGF21 Variant with Optimal Pharmaceutical and Pharmacokinetic Properties to Enable Weekly to Twice Monthly Subcutaneous Dosing. Scientific Reports, 8(1). doi:10.1038/s41598-018-22456-w.
SOFTWARE
APPLICATION NOTES
- Considerations in AAV Genome Integrity Analysis: Guidelines from the Use of ssDNA Ladder on LabChip® GX Touch™ Instrument
- High Sensitivity & High Throughput Stability Assessment of mRNA in Solution & Lyophilized Solids using the LabChip® GXII Touch™ System
- Extended Range Characterization of N-Glycans
- Rapid small-scale protein purification and characterization using the JANUS® G3 BioTx™, LabChip® GXII Touch™ platform, and the AlphaLISA® assay
- LabChip® GXII Touch™ Protein Characterization System Product Note
- LabChip® GXII Touch™ Protein Assay Portfolio
- Characterization of NISTmAb with Microfluidic CE-SDS using the Protein Clear™ HR Assay
- ProteinEXact™ Assay Application Note
- ProteinEXact™ Assay Brochure
- Detection of AAV structure: capsid proteins and nucleic acid composition on LabChip® GXII Touch™ Platform Scientific Poster
- Independent Comparison of Protein Quality Control Analysis; an Evaluation of System Performance: LabChip® GXII Touch™ Protein Clear HR Assay v SCIEX® PA800 Plus System
- Rapid Characterization of AAV Capsid Proteins by Microfluidic CE-SDS
- Characterization of Bispecific Antibodies on LabChip® GX II Touch™ System
WEBINARS
LabChip® Protein Assays
- ProteinEXact™ Assay for Protein Quantitation and Sizing
- Protein Clear™ HR Assay for Purity Assessment
- Protein Express Assay Reagent Kit
- Protein Pico Assay Reagent Kit
- Low Molecular Weight Assay Reagent Kit
- Extended Range N-Glycan Assay
- Glycan Screening Assay Reagent Kit
- Charge Variant Analysis Assays
LabChip® Nucleic Acid Assays