Fast, high-quality non-GMP material to accelerate early research
Reliable GMP-labelled compounds for clinical and regulatory use
Supporting human ADME studies with high-quality ¹⁴C-labelled material
Radiolabelled drug product support from API to finished dose
Isotope labelling as part of an integrated ADME programme:
Our capabilities are available as a standalone service through Arcinova, or included as part of an integrated human ADME programme 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.
We Specialise in Challenging Small Molecule Labelling Projects:
- Complex scaffolds such as complex natural products, macrocycles, protacts
- Difficult site specific, highly embedded labelling positions
- Expert handling of highly potent, hazardous and cytotoxic compounds, from development through GMP manufacture
- Licenced for Scheduled 1-4 controlled substances
- Synthesis of stable-labelled compounds incorporating 2H, 13C, 15N or 18O, ensuring optimal label placement and high isotopic purity
Integrated On-Site Expertise For Seamless Programme Alignment
Advanced solid-state and formulation expertise
Including polymorph screening and control, particle size reduction, lyophilisation, and enabling formulation strategies for poorly soluble radiolabelled compounds, supported by comprehensive solid-state characterisation (PSD, XRPD).
Drug product development and manufacturing
From fit-for-purpose formulation design to sterile manufacturing and IV drug products, supporting efficient delivery of radiolabelled compounds into clinical studies.
Flexible synthesis strategies that accelerate development and reduce cost
Synthetic routes designed from the outset to support both non-clinical and clinical supply, minimising re-synthesis during programme progression. This integrated approach saves time, reduces cost and can accelerate access to human ADME study material when timelines are critical.
Integrated analytical capabilities across development
Comprehensive analytical support from development through release, including in-house microbiological testing for rapid and reliable study support.
Specialist metabolite and reference standard synthesis
Custom synthesised metabolites and reference standards to support bioanalytical method development, metabolism studies and regulatory submissions.
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)
SIL compounds for accurate LC-MS/MS bioanalysis
Stable isotope-labelled (SIL) compounds are the gold standard internal standards for quantitative bioanalysis, improving accuracy and confidence in LC-MS/MS measurements.
Expert synthesis of SIL standards
We synthesise high-quality SIL compounds incorporating ²H, ¹³C, ¹⁵N and ¹⁸O, alongside H/D exchange of APIs and late-stage intermediates, supporting bioanalytical studies from development through clinical programmes.
