Empowering success by adopting new LC instruments within an existing network

Význam tématu

Pharmaceutical contract development and manufacturing organizations (CDMOs) face growing demands for high-throughput, robust and transferable chromatographic methods. Integrating modern UHPLC instrumentation into existing informatics environments enhances method reproducibility, accelerates workflows and optimizes laboratory footprint.

Cíle a přehled studie / článku

This case study examines how Patheon, a Thermo Fisher Scientific CDMO, evaluated and deployed Vanquish UHPLC systems and Chromeleon 7 CDS within their existing Waters Empower 3 environment. The goals were to improve chromatographic performance, simplify method transfer and support Lean Labs productivity gains across global sites.

Použitá metodika a instrumentace

The evaluation compared Thermo Scientific Vanquish Flex and Duo UHPLC systems against Waters ACQUITY UPLC H-Class and Agilent 1260 HPLC. Key features assessed included retention time and peak area reproducibility, method transfer tools (multi-mode column heating, active solvent pre-heating, Viper zero-dead-volume fittings, adjustable gradient delay volume) and system suitability metrics. Informatics integration was tested via Waters Empower 3 and Thermo Scientific Chromeleon 7 CDS.

Hlavní výsledky a diskuse

• Vanquish Flex delivered superior retention time reproducibility (RSD <0.1%) and peak area precision, enabling consistent glycan profiling and peptide mapping under shallow gradients.
• System suitability studies showed Vanquish Flex met or exceeded USP criteria: high sensitivity (S/N >17), minimal tailing and tight RSD for retention time and peak area.
• Method transfer features enabled rapid emulation of competitor systems, reducing adjustment cycles and preserving gradient profiles.
• Chromeleon 7 CDS matched or surpassed Empower 3 for compliance, data integrity and usability, requiring 30–63% fewer mouse clicks and 31–46% fewer windows for common workflows.

Přínosy a praktické využití metody

The Vanquish UHPLC platform improved assay consistency for impurity profiling, glycoprofiling and peptide mapping. The Duo configuration doubled throughput without expanding bench space, supporting Lean Labs initiatives. Chromeleon 7 CDS streamlined data acquisition and processing across multi-vendor instrumentation.

Budoucí trendy a možnosti využití

• Expansion of dual-channel UHPLC systems for parallel method screening and high-throughput QC.
• Greater adoption of active solvent management and advanced column heating for robust method transfer.
• Integration of enterprise CDS and LIMS for end-to-end automation and real-time analytics.
• Leveraging cloud and AI-driven data processing to predict maintenance needs and optimize run sequences.

Závěr

Patheon successfully integrated Vanquish UHPLC systems and Chromeleon 7 CDS into their global network, achieving enhanced chromatographic performance, simplified method transfer and significant productivity gains. This approach supports scalable, compliant and cost-effective pharmaceutical analysis.

Reference

Case Study 72977, Thermo Fisher Scientific, 2019.