Chromeleon 7 Chromatography Data System - From sample to report: Chromeleon CDS end-to-end workflow for bioanalysis

Significance of the Topic

Bioanalytical measurements are essential in drug development to quantify drugs and their metabolites in biological matrices. Advanced workflows streamline data acquisition, improve regulatory compliance, and enhance laboratory productivity in high-throughput environments.

Goals and Overview of the Article

This article presents the Thermo Scientific Chromeleon 7 Chromatography Data System (CDS) as a unified software solution for end-to-end bioanalysis workflows. It highlights features that address sample management, instrument control, data processing, compliance, and reporting.

Used Instrumentation

• High-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS)
• High-resolution accurate mass spectrometry (HRAM MS)
• Thermo Scientific Chromeleon CDS software platform
• Thermo Scientific Watson LIMS gateway

Methodology

The CDS platform integrates LC and MS control, eWorkflow procedures for automated sequence creation, SmartLink for component-centric data review, and built-in report templates tailored for quantitative bioanalysis. Centralized administration ensures GLP, GMP, and 21 CFR Part 11 compliance via audit trails, privilege controls, and versioning.

Main Results and Discussion

The integration of chromatography and mass spectrometry within a single software environment reduces training time and user errors. Compliance features enable side-by-side audit trail comparisons and secure instrument tuning. eWorkflow procedures and SmartLink significantly accelerate sequence setup and data review, while network scalability allows centralized data storage, remote instrument access, and robust failure protection.

Benefits and Practical Applications

• Streamlined sample-to-report workflow with minimal manual intervention
• Enhanced regulatory compliance and full traceability
• Improved reproducibility and reduced operator variability
• Scalable deployment from single workstations to global networks
• Seamless integration with LIMS for end-to-end study management

Future Trends and Possibilities

Continued adoption of HRAM MS will support analysis of complex therapeutics. Cloud-ready architecture and AI-driven data analytics are expected to further optimize bioanalytical throughput. Expansion of remote access and networked laboratories will enhance collaboration and resource sharing.

Conclusion

The Chromeleon CDS platform delivers a comprehensive, compliant, and user-friendly solution for modern bioanalysis. Its unified approach to chromatography and mass spectrometry drives productivity gains and positions laboratories for future technological advancements.