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.
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.
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.