Streamlining productivity and reducing costs: Opella's transition to Vanquish Flex UHPLC

Significance of the topic

Modernizing liquid chromatography workflows in pharmaceutical quality control directly affects throughput, data quality, regulatory compliance, and laboratory sustainability. Upgrading legacy HPLC systems to modern UHPLC platforms enables shorter analysis times, reduced solvent consumption, lower labor burden, and improved method robustness. These gains support both operational efficiency and environmental, health and safety (EHS) objectives while aligning with recent regulatory guidance that encourages analytical lifecycle management and method modernization.

Objectives and study overview

This case study describes how Opella Healthcare's Ocoyoacac (Mexico) site replaced legacy HPLC systems with Thermo Scientific Vanquish Flex UHPLC instruments to modernize analytical methods for an over-the-counter syrup product. Key aims were to: reduce total analysis time, consolidate separate assay/impurity and preservative methods into a single analytical sequence, streamline sample and solvent preparation, ensure seamless integration with existing data systems, and realize cost and environmental savings across routine QC testing (approximately 45 batches/year). The work was conducted in the context of ICH Q14 and revised USP <621> guidances that permit and encourage method modernization and flexibility in chromatographic parameters.

Methodology and method modernization

Opella combined two previously separate chromatographic methods (an assay/related-substances method and a preservatives method) into a single UHPLC method implemented on the Vanquish Flex system. Method modernization steps included selection of modern column chemistries compatible with UHPLC, adaptation of flow and column dimensions to take advantage of higher-pressure operation, simplification of sample preparation, and validation/transfer of the new method from the support lab to QC. Data processing workflows remained under Waters Empower CDS; the Vanquish systems were integrated into the existing Empower network to preserve historical data processing procedures and user workflows.

Used instrumentation

• Thermo Scientific Vanquish Flex UHPLC system, capable of both HPLC and UHPLC modes and accommodating columns up to 30 cm.
• Thermo Scientific Viper fittings to enable leak-free, rapid connections suitable for HPLC and UHPLC applications.
• Existing Waters Empower CDS network for chromatographic data acquisition and processing.

Main results and discussion

Consolidating and modernizing methods delivered substantial performance and operational improvements:

• Run time reduction: The combined UHPLC method reduced total run time from approximately 140 minutes (40 min for assay/impurity + 100 min for preservatives) to 24 minutes, an ~80% reduction in analytical runtime.
• Instrument consolidation: One Vanquish Flex instrument replaced two legacy HPLC systems for this workflow.
• Labor savings: Sample preparation and data processing times were each reduced by roughly 50%, translating into several days of labor saved per year (reported savings included about 3.5 days from data processing reduction and additional savings from sample prep).
• Solvent and consumables: Mobile phase and solvent consumption decreased due to shorter runs and fewer system cycles, contributing to lower waste generation and disposal costs.
• Annual cost estimate: Combined savings (labor and solvents) were estimated at approximately $2,750 per year for the assessed workload (45 lots/year).
• Robustness and usability: Users reported reliable instrument performance and simple connection management with Viper fittings; the Vanquish instrument provided reproducible temperature control (still air and forced air modes) and excellent injection repeatability, supporting consistent results and fewer re-runs.

The transition was described as straightforward from a software-integration perspective: Vanquish systems ran successfully within the existing Empower CDS environment, maintaining continuity of data processing and record keeping.

Benefits and practical applications

Practical advantages demonstrated by this modernization include:

• Increased analytical throughput enabling faster release decisions for routine batches.
• Lower operational costs through reduced solvent purchase and disposal, and decreased labor time.
• Improved EHS profile by reducing analysts' exposure to solvents, decreasing waste, and lowering instrument energy usage due to shorter runs.
• Simplified method management by consolidating multiple tests into a single sequence, easing sample handling and QC scheduling.
• Easier method transfer and cross-application use because the Vanquish Flex supports both legacy HPLC and modern UHPLC conditions.

Future trends and applications

Modernization efforts illustrated here align with broader trends likely to shape chromatographic analytics in pharma and consumer-health QC labs:

• Wider adoption of UHPLC and high-pressure-capable systems to shrink run times while maintaining or improving resolution.
• Green chromatography initiatives emphasizing solvent reduction, alternative solvents, and lower-energy instrumentation.
• Greater use of method consolidation and multi-analyte assays to reduce sample handling and instrument load.
• Enhanced software and data ecosystem integration, including harmonized CDS networks and electronic lab records to streamline method transfer and lifecycle management.
• Application of automated and AI-assisted method development tools to accelerate modernization and optimize chromatographic conditions.
• Increased focus on robustness and reproducibility through advanced fittings, thermostatted compartments, and better injection systems.

Conclusion

Opella's deployment of Vanquish Flex UHPLC systems at the Ocoyoacac site demonstrates that method modernization can produce substantial operational, environmental, and safety benefits with manageable implementation overhead. By consolidating two legacy HPLC methods into one UHPLC method, the site achieved dramatic reductions in run time (~80%), solvent use, and labor while preserving data workflows through integration with existing CDS software. The case reinforces regulatory guidance favoring analytical lifecycle management and shows a clear pathway for QC labs to increase productivity and reduce costs without compromising data quality.

References

1. Thermo Fisher Scientific. Case Study 003059: How Sanofi increased productivity and reduced costs and solvent usage. 2024.
2. International Council for Harmonisation. ICH Harmonised Guideline: Analytical Procedure Development Q14. 2023.
3. United States Pharmacopeia. USP General Chapter <621> Chromatography. United States Pharmacopeia Convention, Rockville, MD.