Shimadzu Nexera lite inert

Importance of the Topic

Proteins such as monoclonal antibodies play a critical role in modern biopharmaceuticals. Their structural integrity and purity must be closely monitored to ensure safety, efficacy and consistent manufacturing outcomes. High-salt mobile phases and interactions with metal surfaces can compromise chromatographic performance and data reliability, making specialized instrumentation essential for robust protein analysis.

Objectives and Overview

This application note presents the Nexera lite inert high-performance liquid chromatography (HPLC) system, designed to address corrosion and adsorption challenges in protein separations. The study evaluates the system’s performance under high-salt conditions, solvent delivery precision, real-time pH monitoring and adsorption-resistant consumables to demonstrate improved reproducibility and data quality in bioseparation workflows.

Methodology and Instrumentation

Size-exclusion chromatography (SEC) and ion-exchange chromatography (IEX) were conducted using phosphate buffers with high salt concentrations to assess antibody aggregate and fragment analysis. Retention time repeatability was measured over multiple injections, and real-time pH data were recorded alongside UV detection profiles. Sample adsorption studies compared TORAST-H Bio vials with conventional vials.

Used Instrumentation:

• Nexera lite inert HPLC system with metal-free flow path
• TSKgel G3000SWXL SEC column
• Shim-pack Bio Diol IEX/SEC column and Shim-pack Bio Diol size-exclusion column
• SIL-20A autosampler equipped with inert kit
• SPD-40 UV-Vis detector and PDA detector (SPD-M40)
• pH monitor pHM-40 for continuous mobile phase pH tracking
• TORAST-H Bio adsorption-resistant sample vials

Main Results and Discussion

The inert flow path eliminated corrosion effects even with high-salt mobile phases, yielding stable aggregate assays with high repeatability. Solvent delivery accuracy supported retention time RSD of 0.08% across five injections. The pHM-40 module provided synchronized pH and chromatogram data, enabling direct correlation of separation shifts with pH variations. TORAST-H Bio vials achieved near-complete recovery (100%) for basic compounds, compared to only 38–86% recovery with other vial types, highlighting their benefit in trace analyte detection.

Benefits and Practical Applications

The Nexera lite inert system ensures long-term stability and reproducibility in protein analyses without frequent maintenance or corrosion concerns. Its precise solvent delivery enhances retention time consistency, while real-time pH monitoring improves method validation and troubleshooting. Adsorption-resistant vials maximize sample recovery, making the platform ideal for QC labs, bioprocess development and research in biologics manufacturing.

Future Trends and Opportunities

Advances in inert LC systems will likely integrate automated sample handling, multi-parameter sensors and AI-driven diagnostics to further streamline high-throughput biologics analysis. Expansion of inert kits for UHPLC platforms and enhanced consumable chemistries may broaden applications across proteomics, peptide mapping and gene therapy vector characterization.

Conclusion

The Nexera lite inert HPLC system addresses key challenges in protein separations by combining a metal-free flow path, high-precision solvent delivery, real-time pH monitoring and adsorption-inhibiting consumables. This comprehensive solution offers reliable, reproducible performance for biopharmaceutical quality control and research, enabling robust analysis of aggregates, fragments and other critical quality attributes.