At Quotient Sciences, 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.
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-labeled high-potency/high-hazard compounds (cytotoxics) and 14C-labeled gases and volatiles, including 14CO2. Our facilities are UK Medicines and Healthcare products Regulatory Agency (MHRA)-accredited, and we offer full Good Manufacturing Practice (GMP) synthesis of 14C-labeled compounds for human studies.
Customers who have placed both their pre-clinical 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 Synthesis-to-Clinic® approach pulls all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work–from radiosynthesis to final clinical report. 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 Sciences project manager.
On-site pharmaceutical sciences facilities for the development, real-time GMP manufacture, and Qualified Person (QP) release of 14C drug products enable us to seamlessly supply 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, which allows us to support ADME studies in patients at specialist clinics.
Learn more about our expertise and capabilities in our whitepaper, Synthesis to Clinic: A streamlined approach to 14C human ADME studies.
Our heritage in drug development and the presence of bioanalytical experts under the same roof allow us to design and deliver stable isotope labeled internal standards with the correct properties for successful bioanalysis studies.
Human ADME studies provide data for mass balance, pharmacokinetics, and metabolite characterization. This allows detailed understanding of the metabolism of a drug candidate to support regulatory submission.
A synthesis of the drug candidate is designed that uses a radioactive starting material to introduce one or more 14C atoms into the final structure. The labeling position is chosen to maximize the metabolic data that can be determined and builds upon hundreds of years of 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 unlabeled compound, but the presence of the radioactive element allows quantification of the parameters being studied.
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. SIL materials provide ideal internal standards for studying development candidates.
A copy of the molecule is produced containing SIL atoms. These are not radioactive but can be distinguished from the unlabeled material by mass spectrometry, enhancing the accuracy of the measurements made.
Iain Shaw is Senior Director of 14C Enabled Drug Development at Quotient Sciences. Iain has over 30 years of experience in the pharmaceutical industry, including more than 20 years of drug development experience and extensive experience with 14C human ADME studies.
Our team of experts have extensive chemical and radiochemical knowledge and experience of isotopically labeling hundreds of molecular entities. Contact us today to discuss your program and learn how we can help you accelerate your path to the clinic.