Isotope Labelling

Ensuring secure and rapid delivery of isotopically labelled (14C/SIL) materials to support your non-clinical and clinical development.
With a 30+ year track record, our highly trained chemists have extensive chemical & radiochemical knowledge and experience of isotopically labelling hundreds of molecular entities.
At Quotient, we are focused on accelerating your drug compounds to the clinic. Our team of experts provide guidance on the design and conduct of both non-clinical and clinical human ADME studies for research, development and regulatory purposes. Customers who have placed both their preclinical and clinical studies with us, have shortened their time to clinic and saved on development costs by avoiding the need for re-synthesis. We have a 98% delivery rate and we take great pride in delivering on time and in full for our customers. 
Our radiochemists work closely with our  analytical and drug product teams to deliver a “solution focused” service to our customers throughout all stages of drug development.  We are experts in the safe handling of 14C- high potency/ high hazard compounds (cytotoxics) and 14C-labelled gases and volatiles, including 14CO2.  Our facilities are MHRA accredited, and we offer full GMP synthesis of 14C-labelled compounds for human studies.

Our state-of-the-art isotope labelling equipment includes:

  • Vacuum manifold equipment for handling volatile 14C starting materials,
  • Preparative chromatography systems to maximize radiolabelled material recovery with high velocity
  • HPLCs
  • LC-MS
  • GC-MS
  • liquid scintillation counters
  • radio-TLC imagers
  • H-Cube flow hydrogenation systems.

Our heritage in drug development and the presence of bioanalytical experts under the same roof allow us to design and deliver stable isotopic labelled internal standards with the correct properties for successful bioanalysis studies.

Facilitated by Synthesis-to-Clinic®

Our Synthesis-to-Clinic® support – from radiosynthesis to final clinical report – pulls all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work. It drives efficient development and manufacturing of 14C drug products tailored to the specific requirements of your ADME program — including intravenous (IV) products to generate IV pharmacokinetic and absolute bioavailability data, where appropriate.  This platform supports your entire ADME program, from radiosynthesis through to clinical reporting, delivering all of these components on your behalf under the guidance of a single Quotient project manager.

On-site pharmaceutical sciences facilities for the development, real-time GMP manufacture and QP release of 14C drug products enable us to seamlessly supply of oral and parenteral formulations for ADME studies.  GMP manufacturing of 14C drug product is conducted in the same building as clinical dosing and real-time adaptive manufacturing allows us to support ADME studies in patients at specialist clinics.

Isotope labelling services include:

14C Radiolabelling

Human ADME studies provide data for mass balance, pharmacokinetics and metabolite characterisation. This allows the detailed understanding of the metabolism of a drug candidate to support regulatory submission.

A synthesis of the drug candidate is designed which uses a radioactive starting material to introduce one or more -14C atoms into the final structure. The labelling position is chosen to maximize the metabolic data that can be determined and builds upon hundreds of man years’ experience in designing short and economical routes ensuring high velocity of material delivery. The material produced has the same pharmacokinetic and metabolic properties as the unlabelled compound, but the presence of the radioactive element allows quantification of the parameters being studied.

Stable Isotopic Labelling

Mass spectrometry is the workhorse of bioanalysis, with millions of samples being analyzed daily across the world. Accurate quantification of the test substance is key and is accomplished using an internal standard. Stable isotopic labelled materials provide ideal internal standards for studying development candidates.

A copy of the molecule is produced containing isotope-labelled atoms. These are not radioactive but can be distinguished from the unlabelled material by mass spectrometry, enhancing the accuracy of the measurements made.

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