Highest industry standards
From early discovery activities through to GLP TK studies, Concept Life Science’s in vivo ADME team supports projects from inception to final report. Our services include client consultation at project outset, preparation of protocols and project management of both internal and external activities. We work to the highest industry standards and strict acceptance criteria to ensure our data is of the high quality.
Our discovery ADME and bioanalytical labs are capable of rapid method development for early stage PK studies and ‘cold’ tissue distribution studies whilst our regulatory bioanalytical laboratories are GLP accredited and as such have the capability to develop and validated fully compliant methodologies in support of GLP TK studies.
In addition to bioanalytical determinations, our labs also support biomarker assays and in vivo Biotransformation. Concentration data is also further processed to provide pharmaco and toxicokinetic information using industry standard Phoenix WinNonLin software.
By understanding the project and client needs as fully as possible, our in vivo ADME scientists the most appropriate approaches and experiments. Our experience allows us to take a logical approach to novel assay development and troubleshooting, engaging with clients frequently throughout the assay development process.
Early assessment of compounds through to regulatory bioanalysis
Concept offers a wide range of in vitro screens, in vivo 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.
In vivo ADME capabilities
- Bioanalytical method development and validation
- Determination of PK/TK parameters
- Microsampling PK capabilities (DBS, CMS, VAMS and Blood:Water)
- Bile duct cannulated studies
- Organ distribution
- Brain distribution and CSF sampling
- In vivo metabolism