Metabolite Profiling and Identification
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Set the Stage for Success
Gain a better understanding of your metabolites with WuXi AppTec’s Biotransformation services supporting Metabolite Identification (Met ID) projects from early discovery through New Drug Application (NDA) submission. We provide 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 to set the stage for success in clinical trials. Our highly experienced Met ID scientists work in tandem with the entire DMPK program to provide the necessary information needed to take the compound from concept to candidate.
- Identify soft spots, active and reactive metabolites in various in vitro test systems (microsomes, hepatocytes, S9) and in vivo samples to optimize lead compounds for a balanced DMPK profile.
Met ID in IND-Enabling and Pre-clinical Development
- In vitro Met ID species comparison to obtain important information about human and animal metabolites and their potential impact on the safety and efficacy profiles of investigational new drugs.
- 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 and tissues, etc.).
Met ID in Clinical Development
Benefit from a track record that provides industry leading clinical Met ID to understand circulating human metabolites at steady state and their exposure coverage in safety species. Our programs include:
- 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
Services and Instruments
- 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
- Topcount®, Thermo Q Exactive™, Waters Xevo™ G2-XS QTof , 1-D and 2-D NMR
- Isolation and purification of metabolites for reference standards