Protein Assays

• AAV EMPTY FULL ANALYSIS
• 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 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 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.

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.

• Sun, Y. et al. (2023) ‘Application of microfluidic chip electrophoresis for high-throughput nucleic acid fluorescence fragment analysis assays’, NAR Genomics and Bioinformatics, 5(1). doi:10.1093/nargab/lqad011.
• 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.