CDS Software—Built for Biopharma

The complex structures of biopharmaceutical therapeutic agents require greater selectivity and sensitivity, which drives the demand for powerful instrumentation and software to acquire and analyze them. Previously this required two software packages, one in Development and one in Quality Control (QC). Thermo Scientific Chromeleon 7.3.1 Chromatography Data System (CDS) comfortably operates in both areas and supports Mass Spectrometry (MS) instruments in a compliant enterprise environment, providing a seamless transition from Development to QC within a single software platform.

Support for biopharmaceutical workflows

Chromeleon CDS provides native control of MS and MS/MS instruments (for GC, HPLC, and IC front ends) with workflow support for targeted MS-based quantitation, including lot release testing of intact and digested proteins and LC-MS/MS-based pharmaceutical bioanalysis.

• Control for over 35 Thermo Scientific MS instruments including single and triple quadrupole and Orbitrap high resolution accurate mass (HRAM)
• Workflow support including bioanalysis, multi-attribute method (MAM), intact protein analysis, dioxin and PCB analysis, and SVOCs
• Built-in report templates and views specific to the needs of analysts conducting bioanalysis experiments
• Bi-directional connections for Thermo Scientific SampleManager and Watson LIMS Software for complete end-to-end support

Learn more about Chromeleon CDS features for mass spectrometry ›

Built for compliance: Leverage compliance tools for your MS

• Chromeleon CDS is the recommended software to control Thermo Scientific MS instruments for compliant analysis. Compliant tuning for Thermo Scientific ISQ, TSQ and Exploris series MS instruments
• Achieve compliance with a full suite of features to ensure adherence to regulations, data integrity guidelines, and electronic record requirements
• Maintain compliance with user controls and comprehensive audit trails to track and version all actions
• Demonstrate compliance with easy, regular audit trail reviews
  • Audit trail events and queries quickly and clearly present the info needed
  • Versioning shows how changes have affected results

Built for QC: Up to 33% increased efficiency for routine MS analyses

Feel confident with fewer failed runs and out-of-specification results through:

• Built-in troubleshooting and diagnostics for specific Thermo Scientific HPLC and UHPLC systems to minimize downtime
• Pre-run sequence ready checks and runtime evaluation of SSTs with Intelligent Run Control for results-based reactions, deliver more "right-first-time" analyses
• Enhanced universal eWorkflow procedures streamline and control sequence creation to simplify adherence to SOPs
• Spreadsheet-based report templates to calculate the results inside the CDS

Built for MAM: Straight through to breakthrough

Chromeleon CDS is an integral part of the Thermo Scientific MAM 2.0 workflow. This powerful, high-resolution MS-based workflow delivers easy, compliance-ready characterization and monitoring of peptides and allows critical quality attributes to be monitored throughout every stage of the drug development process. The workflow leverages comprehensive compliance capabilities from data acquisition, to quality attribute quantitation, new peak detection, and customizable spreadsheet-based reporting.

Built for Bioanalysis: Small molecule bioanalysis and DMPK studies

Understanding your molecules is critical, and ensuring accuracy is paramount when it comes to DMPK studies. Chromeleon CDS provides a single software solution that is scalable,from a local standalone workstation to a multi-site enterprise system, with built-in features to simplify meeting compliance requirements. It provides robust and reliable control of the HPLC and MS with integrated MS/MS functionality for data acquisition and processing. A bi-directional gateway for the Watson LIMS provides complete end-to-end support.