Bioanalysis

Method Development and Validation
A dedicated team evaluates assay requests from a strategic and scientific point of view. Methods proprietary to SGS or the sponsor are developed with focus on high-throughput technological capabilities (TurboFlow extraction, Multiprobe robots).

SGS offers more than 600 validated methods that are ready for use with very short lead time. Validation criteria follow guidelines from FDA (May 2001) and the Crystal City Conference (May 2006).

All validations are tailored to specific program requirements

C14-based ADME Study Capabilities

• Executed in collaboration with SGS own Phase I unit in Belgium  
• Mass balance established in 6 to 8 studies in human per year
• Human metabolism studies by advanced LC-MS/MS and other technologies (QTrap, QTof, TopCount)
• Liquid scintillation counting and sample combustion for radiocarbon determination (mass balance studies)
• Determination of protein binding
• HPLC with on-line radio detector and MS for metabolic profiling
• Analysis of unlabeled drug by LC-MS/MS

Early to Late clinical trials and Post-Marketing
To support the bioanalysis of various classes of compounds, SGS offers a large range of techniques and methods. In addition, an exceptional sample processing and analytical capabilities, combined with scientific expertise, enables SGS to provide rapid, high-volume bioanalysis:

• Mass spectrometry
  • 24 LC-MS/MS, 5 GC-MS
• Immunoanalysis
  • RIA, ELISA measurements for routine analysis of a variety of molecules including therapeutic proteins
• Classical HPLC
  • 6 HPLC systems equipped with UV, fluorescence and electrochemical detectors
• Automated sample preparation using robotics (Multiprobe) or turbulent flow technology (Cohesive)
• Large sample storage capacity combined with excellent sample tracking (400 000 sample storage and equivalent backup)
• Current throughput of more than 200,000 incurred samples per year