Alliance iS Bio HPLC System brochure

Importance of Bioseparations in Biopharma Quality Control

Biopharmaceutical laboratories require robust, simple, and reproducible methods to ensure product quality while reducing analysis time and error rates. As therapeutic modalities evolve and sample complexity grows, non-specific adsorption, system conditioning delays, and data integrity concerns pose significant challenges. An intuitive HPLC platform with inert flow paths and advanced surface technology can address these needs, accelerating time to result and supporting regulatory compliance.

Objectives and Overview

This web article highlights the Alliance iS Bio HPLC System equipped with MaxPeak High Performance Surfaces (HPS) Technology. Key goals include demonstrating:

• Reduction of non-specific adsorption and sample passivation time
• Improvement in reproducibility, sensitivity, and data integrity
• Ease of use through intuitive hardware and software integration

Used Instrumentation

The Alliance iS Bio HPLC System features:

• MaxPeak HPS Technology on all wetted surfaces to minimize analyte loss
• Corrosion-resistant, bio-inert materials for high-salt and metal-sensitive analyses
• Color-coded tubing clips and bottle flags to prevent solvent mix-ups
• Touchscreen interface with guided setup, diagnostics, and error prevention checks
• System status lighting and Empower Software integration for comprehensive data management
• Intelligent Method Translator App (iMTA) for seamless migration of legacy methods
• eConnect NFC-enabled columns for digital column identification and method setup

Key Results and Discussion

Performance gains were demonstrated across multiple analyte classes:

• Oligonucleotides: 30 percent increase in peak height and 15 percent increase in peak area, yielding greater sensitivity and recovery
• Monoclonal antibodies (SEC): Resolution improved from Rs 1.66 to Rs 2.61, with lower dispersion and full compliance with compendial suitability criteria
• Peptides and phosphopeptides: Enhanced peak shape and retention consistency under gradient elution, reducing variability and improving quantitation
• Method transfer: Up to 40 percent boost in signal-to-noise ratio when translating methods via iMTA, eliminating manual re-optimization

Benefits and Practical Applications

The system delivers:

• Faster time from sample to result by removing column conditioning steps
• Reduced carryover and injection variability for high-throughput QC environments
• Improved data integrity and audit readiness via Empower Software and digital column tags
• Consistent performance across diverse workflows including oligonucleotide, mAb, peptide, AAV, and mRNA analyses

Future Trends and Potential Applications

Emerging directions in bioseparation include fully digital laboratories with smart consumables, automated method translation, and enhanced connectivity for predictive maintenance. Continued innovation in surface coatings and inert flow paths will support next-generation biologics such as lipid nanoparticles and gene therapies, enabling higher throughput and tighter control of critical quality attributes.

Conclusion

The Alliance iS Bio HPLC System with MaxPeak HPS Technology represents a significant advancement for biopharma QC labs. By combining inert hardware, intuitive software, and digital support tools, it addresses core challenges in reproducibility, sensitivity, and regulatory compliance. This platform can streamline workflows, elevate data quality, and prepare laboratories for future biologics applications.