Carbon-14 Bioanalysis
Carbon-14 Bioanalytical Services
Pharmaron provides 14C and 3H bioanalytical services in support of discovery, preclinical and clinical ADME studies. The bioanalytical platforms include HPLC, UPLC, Liquid Scintillation Counter (LSC), Accelerator Mass Spectrometer (AMS) for quantification of radioactive materials (parent and metabolites). In addition, Pharmaron has also established imaging-based quantification techniques, including QWBA and MARG to quantify radioactive materials’ distribution in whole animal or tissues or cells. These platforms have been established meeting the regulatory requirements in support of regulatory submission.
Capabilities
Discovery and Preclinical Carbon-14/Tritium Bioanalysis
- Development for a selective HPLC or UPLC method for parent API and metabolites
- Method development for LC-LSC bioanalysis
- Imaging-based QWBA and MARG distribution analysis
- Platform: HPLC and UPLC, LSC and LC-LSC (LC-RAD, LC-TopCount®), Liquid Handling Automation Station, QWBA and MARG system
Discovery and Preclinical Carbon-14/Tritium Bioanalysis
- Analyte: 14C-/3H-parent API and metabolites
- Matrix: Animal samples including tissue, blood, plasma, serum, urine and feces, and from cell and various in vitro settings
- Applications: Discovery and preclinical metabolism studies, including mass balance, metabolic profiling, absolute quantification of metabolites in vitro and in vivo, total PK, metabolite burden, quantitative distribution of radioactive materials in tissues and cells
Clinical Carbon-14/Tritium Bioanalysis
- Method development and validation for a selective HPLC or UPLC method for parent API & metabolites
- Method development and validation for LC-LSC bioanalysis of parent API and metabolites
- Method development and validation for ultrasensitive LC+AMS bioanalysis of parent API and metabolites to support clinical 14C-microtracer studies and low exposure 14C-material analysis
- LC-MS/MS sample analysis for unchanged parent (GLP/GCP compliant facility)
- Bioanalytical methods and sample analysis in accordance with FDA/EMA/ICH guidelines
- Platform: HPLC and UPLC, LSC and LC-LSC (LC-RAD, LC-TopCount®), LC+AMS, Liquid Handling Automation Station
- Analytes: 14C/3H-parent API and metabolites
- Matrix: samples taken from subjects – blood, plasma, serum, urine, feces
- Applications: Clinical metabolism studies – mass balance, metabolic profiling, absolute quantification of metabolites; Total PK (determination of total 14C-concentrations by LSC and/or AMS for whole blood, urine, feces); IVPK study for APIs designed with admin route of non-IV dosing in clinical
