How Sanofi increased productivity and reduced costs and solvent usage

Significance of the Topic

Modernizing liquid chromatography workflows is critical for pharmaceutical quality control and research laboratories seeking higher throughput, lower operational costs and reduced environmental impact. The transition from traditional HPLC to ultra-high-performance LC platforms supports regulatory expectations for analytical lifecycle management and aligns with sustainability initiatives.

Objectives and Study Overview

Sanofi’s Compiègne site partnered with Thermo Fisher Scientific to replace aging HPLC systems with Vanquish Flex UHPLC instruments. The goals were to enhance productivity, streamline assay and impurity testing, reduce solvent consumption and labor, and meet new ICH Q14 and USP <621> guidelines that encourage method modernization and flexible gradient adjustments.

Methodology and Instrumentation

The development team redesigned high-volume assay and impurity methods for the Vanquish Flex platform. They consolidated separate analyses into a single run by using dual-wavelength detection and unified sample preparations, eliminating multiple mobile phases and reducing agitation steps.

Used Instrumentation

• Thermo Scientific Vanquish Flex UHPLC system
• Thermo Scientific Viper Fingertight fittings for leak-free column connections
• Empower chromatography data software with full audit trail

Key Results and Discussion

• Run time per combined assay/impurity analysis dropped from 60 minutes to 5.5 minutes (91% reduction).
• A comparative study on three lots (with content uniformity) saw instrument time fall from 13h35 to 2h57, saving 10.6 hours and cutting solvent use from 1,222 mL to 133 mL (82% reduction).
• Annualized benefits include 106 fewer instrument days, 109 L less solvent, and labor/disposal savings of approximately $7,070.
• Sample preparation time decreased by 33 days per year, with solvent savings of 200 L and cost reduction of about $6,000; combined sample prep and operational efficiencies yield over $12,000 additional annual savings.
• System performance improved reproducibility (<1% RSD) and eliminated system suitability failures; autosampler capacity doubled throughput for dissolution studies.

Benefits and Practical Applications

Implementing UHPLC methods enables:

• Significant throughput increase and reduced instrument occupancy
• Lower solvent consumption and waste disposal costs
• Streamlined sample preparation workflows and fewer user errors
• Enhanced sustainability and analyst safety by minimizing solvent exposure

Future Trends and Potential Applications

Continued adoption of high-efficiency chromatography will likely integrate further automation, smaller particle columns and environmentally friendly solvents. Advances in method lifecycle management, guided by ICH and USP, will drive broader acceptance of flexible gradient protocols and real-time monitoring in both R&D and QC contexts.

Conclusion

Upgrading to Vanquish Flex UHPLC systems and modernizing analytical methods delivers substantial productivity, cost and sustainability gains. The partnership between Sanofi and Thermo Fisher Scientific illustrates how regulatory alignment, technological innovation and optimized workflows can transform pharmaceutical laboratories.

References

1. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Analytical Procedure Development Q14, Draft version, November 2023.
2. Thermo Fisher Scientific. Allowable adjustments of chromatographic conditions: United States Pharmacopeia USP <621>, 2023.