Isotopic Labelling Services
14C Radiolabelling Services:
• Custom synthesis of 14C-labelled compounds to support pre-clinical ADME studies
• GMP synthesis of 14C-labelled compounds for human AME studies
• Expertise and facilities for handling 14C-labelled gases and volatiles including 14CO2, 14CO, 14CH3I
Where possible we will recommend the synthesis of additional 14C-labelled late stage pre-clinical intermediates, which can be stored and used in subsequent GMP studies. This approach can avoid the need for a re-synthesis, saving both time and cost when providing labelled material for the hAME study.
Stable Isotopic labelling:
• Synthesis of stable-labelled compounds incorporating 2H, 13C, 15N or 18O
• Ability to perform H/D exchange on API or late stage intermediates
The use of stable labelled standards is recommended by EMA (Guideline on Bioanalytical method validation), AAPS/FDA (BMV Conference Report) and endorsed by the European Bioanalytical Forum and Global Bioanalytical Consortium. They provide increased speed, sensitivity, selectivity and robustness of LC-MS assays avoiding matrix effects, producing more reliable data.
Additional Experience and Services:
• Ability to safely handle high potency / high hazard compounds (cytotoxics)
• Synthesis of metabolites & reference materials aiding Bioanalytical and Metabolism studies
• Degradants and process impurities to support API development,
• GTI assessment of confirmed impurity / degradant structures found during the scientific evaluation of investigational drug substances and products, to comply with ICH M7 guidance.
• Route development and precursor synthesis for labelling with 3H and short lived isotopes 11C and 18F
• Experienced in classical and non classical synthetic techniques, microwaves, H/D-cubes, automated peptide synthesis, microbiological and bio-catalysis.