Metabolite Profiling and Identification

Biotransformation services from discovery through submission

WuXi AppTec provides analysis for in vitro and in vivo systems utilizing advanced Liquid Chromatography (LC)-High Resolution Mass Spectrometry (HRMS), Ultra Violet (UV), radio-detection and Nuclear Magnetic Resonance (NMR) techniques for profiling, identifying and elucidating structures of important metabolites.

 This analysis helps you understand the metabolic pathways in non-human and human species, setting the stage for success in clinical trials and helping you take your compound from concept to candidate.

 Our Capabilities Include:

• Planning and consulting for the radiolabel study program (labeling position and isotope, quantities needed, specific activity, radiochemical purity, etc.)
• Radio-synthesis of 3H or 14C-labelled compounds
• Isolation and purification of metabolites for reference standards

Met ID in Drug Discovery

• Identify soft spots, active and reactive metabolites in various in vitro test systems (microsomes, hepatocytes, S9) and in vivo samples

Met ID in IND-Enabling and Pre-clinical Development

• In vitro Met ID species comparison
• In vivo metabolite profiling and identification in rodent and large animal species of Pharmacokinetic (PK) and Bile Duct Cannulation (BDC) studies (plasma, blood, bile, urine, feces, tissues, etc.)

Met ID in Clinical Development 

• Metabolite searching and ID from early clinical SAD/MAD studies – semi-quantitative
• Cross-species comparison in plasma at steady state –”Guidelines for Industry Safety Testing of Drug Metabolites” (MIST) coverage
• Human radiolabel mass balance with metabolite radio-profiling and ID
• Key metabolite quantitation with authentic standards via LC-MS/MS

Instruments

• Topcount®
• Thermo Q Exactive™
• Waters Xevo™ G2-XS QTof
• 1-D and 2-D NMR