Early assessment of compounds through to regulatory bioanalysis
Concept offers a wide range of in vitro screens, in vivo Drug metabolism and pharmacokinetics (DMPK) bioanalysis techniques, and metabolite analyses services to support the early assessment of compounds, through to regulatory bioanalysis appropriate for submission to authorities.
Our in vitro services include test item characterization, as well as an evaluation of physiochemical properties, permeability, tissue binding, metabolism, and drug-drug interactions. The ADME team can also support each stage of an in vivo project from inception to final report.
Concept manages established, routine screens with high compound throughput via our liquid handling and automated data management systems. We typically employ protein precipitation for rapid sample processing but are also experienced with more complex sample extraction techniques, such as liquid-liquid extraction, solid phase extraction and chemical derivatization.
We support a range of analytical techniques and tailor our service to the particular needs of each project. Most frequently, our method of quantitative analysis for samples is liquid chromatography and tandem mass spectrometry. Assay acceptance criteria are decided in collaboration with our clients at study initiation as a standard procedure.
In addition to small molecule evaluation, we can offer support biotherapeutics. These include peptides, oligonucleotides and surrogate peptide quantification by LC-MS/MS for larger protein-based modalities. For more complex classes of therapeutics, such as antibody drug conjugates, we also offer characterization and quantification of via combined ligand binding, LC-MS/MS and high resolution accurate mass analysis.
Our ADME team emphasizes the value of time and resource at project initiation to ensure we understand our clients’ needs as fully as possible and can suggest the most appropriate approaches and experiments.
Concept is well positioned to meet the needs of our clients whether they require quick-turnaround data from routine screens, or customized assays for analytically challenging molecules.