Carbon-14 Radiosynthesis
Carbon-14 Radiosynthesis Services
Pharmaron’s radiosynthesis team prepares and releases radiolabelled test compounds for use in non-clinical studies, clinical drug development and environmental fate studies. We provide expert advice on radiosynthetic chemistry, synthesis routes and where to place the radiolabel in the molecule so that it is located in a metabolically stable position. This includes molecules subject to cleavage that may require a radiolabel in two positions to adequately characterize their metabolites and metabolism.
Pharmaron provides consultation on synthesis routes, label position, specific activity and product specification and has dedicated project teams with chemists and analysts.
The team is experienced with volatile compounds, aromatics, heterocyclics, chiral compounds, peptides (peptide synthesis via solution chemistry/synthesizer), proteins (including radiolabelling by fermentation), fusion proteins, oligos, conjugates, polymers and constructs.
Capabilities
Carbon-14 Radiosynthesis Areas of Expertise
- Covalent radiolabelling techniques with 14C (RadioTag) for various molecule types
- 14C peptides (via solution chemistry and/or auto-synthesizer)
- 14C proteins (including recombinant proteins by fermentation)
- 14C biomolecules via fermentation (Class 2 Containment/Class 1 GMOs)
- 14C covalent radiolabelling methods to rapidly “tag” molecules for ADME studies
Analytical Chemistry Support
- Mass spectrometry (LC-MS/MS)
- HPLC or UPLC (including radio-detection and characterization of polymers)
- NMR, GC, FT-IR, DSC, TGA, KF
- Radiochemical purity (RCP)/chemical purity (CP)
- Chemical concentration (CC)
- Specific activity (SA)
- Structural confirmation/identity
- Audited partners for ICP-MS of trace metals, bioburden analysis or bioburden testing
Download PDF to learn more about Pharmaron’s Manufacture of 14C Radiolabelled Drug Substances and Drug Products for Clinical Studies.
