Isotope labelling as part of an integrated ADME program:
Our capabilities are available as a standalone service through Arcinova, or included as part of an integrated human ADME program delivered by Quotient Sciences: Synthesis-to-Clinic™.
Quotient Sciences Synthesis-to-Clinic™ is a holistic platform for ADME studies that combines development and GMP manufacturing of 14C-labelled drug substances and drug products, and flexibility to support parenteral (IV) dosing for intravenous pharmacokinetic and absolute bioavailability data from Quotient Sciences’ Nottingham, UK clinic.
Key applications of our radiolabelling expertise:
- Safe handling of highly potent, hazardous, and cytotoxic compounds
- Licenced for Scheduled I-IV controlled substances including cannabinoids, ketamine, and tryptamine
- Synthesis of stable-labelled compounds incorporating 2H, 13C, 15N or 18O, ensuring optimal label placement and high isotopic purity
- Expertise in polymorphic control, particle size reduction, lyophilisation, and polymer dispersion for poorly soluble radiolabelled drugs
- Synthesis of metabolites and reference materials tailored for bioanalytical and metabolism research.
- Microbiological and solid-state (PSD and XRPD) analysis to support all stages of your development process.
Our facilities are equipped with the latest technologies to ensure the highest precision and quality in radiolabelling.
- Vacuum manifold equipment for handling volatile 14C starting materials
- Preparative chromatography systems
- High-performance liquid chromatography (HPLC) with flow scintillation analysis
- Liquid chromatography-mass spectrometry (LC-MS)
- Gas chromatography-mass spectrometry (GC-MS)
- Liquid scintillation counters
- Radio-thin-layer chromatography (radio-TLC) imagers
- H-Cube flow hydrogenation systems
- Nuclear Magnetic Resonance (NMR) spectroscopy
- Karl-Fisher coulometry
- Freeze dryer
Arcinova: Your partner in Stable Isotope Labelling (SIL)
Mass spectrometry, the backbone of bioanalysis, enables precise quantification of test substances across millions of samples worldwide.
To ensure accuracy, Stable Isotope Labelled (SIL) compounds are ideal for studying development candidates. Non-radioactive SIL atoms are distinguishable from unlabelled molecules by mass spectrometry, enhancing measurement accuracy.
The use of stable labelled standards is recommended by EMA (guideline on bioanalytical method validation) and AAPS/FDA (BMV Conference Report), and is also endorsed by the European Bioanalytical Forum and Global Bioanalytical Consortium.
With extensive experience across a range of molecules, we’ve supported numerous bioanalysis studies and specialize in synthesizing SIL compounds incorporating 2H, 13C, 15N, or 18O and can perform H/D exchange on APIs or late-stage intermediates, providing the expertise needed to ensure your project’s success.
