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Radiolabelled Chemical Synthesis

With the largest, most accomplished team of radiochemists, an experienced leadership team (many with more than 20 years in custom radiochemical synthesis), GMP manufacturing certification and GLP QC laboratories,  we provide expert advice on radiochemical synthesis design and position of label, prepare and release labelled test compounds for use in non-clinical and clinical drug development and in environmental fate studies.

Carbon-14 radiochemical synthesis

More than 200 custom preparation projects completed per year with particular experience in labelling:

  • volatile compounds, aromatics, heterocyclics, chiral compounds, peptides/proteins, oligonucleotides, conjugates, polymers
  • biomolecules using fermentation (Class 2 containment and Class 1 GMOs)

Tritium radiochemical synthesis

More than 150 custom preparation projects completed per year with particular experience in labelling:

  • aromatics, heterocyclics, steroids, chiral compounds, peptides/proteins, oligonucleotides, antibody-drug conjugates, linkers
  • macromolecules using NSP tagging

GMP radiochemical synthesis (labelled materials for use in clinical trials)

Expert advice provided on regulatory requirements for synthesis and release of labelled test materials [drug substance (API) and drug product (IMP)].  More than 100 GMP projects have been completed.  5 successful MHRA facility audits have been conducted and full support for client QA audits is provided.

  • GMP synthesis of C14 labelled API (bulk or packaged)
  • GMP-compliant C14 labelled API purification
  • GMP manufacturing of C14 labelled IMP
  • solutions
  • suspensions
  • hard shell capsules
  • GMP QC laboratory
  • QA release of GMP C14 labelled API
  • QP release of C14 labelled IMP
  • Support for preparation of regulatory documentation
  • Project management

QC facilities

Comprehensive analytical capability including GLP analysis:

Mass spectrometry, HPLC (radioactivity detection and characterisation of polymers), NMR (multi-nuclear capability), GLC, FT-IR, DSC, TGA, KF, endotoxins