Accelerating your drug compounds to the clinic.
State-of-the-art equipment for isotopic labeling
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.
- Vacuum manifold equipment for handling volatile 14C starting materials
- Preparative chromatography systems to maximize radiolabeled material recovery with high velocity
- High-performance liquid chromatography (HPLC)
- 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
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.
Stable isotope labeling (SIL)
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.
Meet our expert
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.