API

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.