API Development

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. 

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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.

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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. 

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