Bioanalytical and Metabolism services
ARCINOVA provides comprehensive bioanalytical services that complement your drug discovery and development needs from preclinical development through to market. Within our state of the art facility, our experienced team can develop, validate and implement bioanalytical LC-MS assays for small and large molecule drugs, generics and biomarkers. Arcinova can also synthesise stable labelled standards to help provide increased speed, sensitivity, selectivity and robustness of LC-MS assays avoiding matrix effects and producing more reliable data.
In addition, we have extensive knowledge and experience of Inductively Coupled Plasma Mass Spectrometry (ICP-MS), particularly for platinum-containing drugs, but also spanning a wide range of elements and matrices. Our new services now include elemental ADME and LC-ICP-MS elemental speciation. Whether you need to make a quick internal decision with data generated using the principles of scientific validation, or require more rigorous EMA/FDA compliant bioanalysis to support eco-toxicology or pivotal bioequivalence studies, we can help.
We can determine the metabolic fate of your molecule or study its activity in cell based systems. Working in collaborative teams, our knowledge base draws from biotransformation specialists alongside biochemists and synthetic/analytical chemists. Our analytical capabilities include high resolution mass spectrometry, NMR and 96 well plate spectrophotometric technology. Both radiolabelled and non-radiolabelled samples are equally accommodated.
In our state of the art facility, incorporating the latest IT solutions, our experienced team have access to cutting-edge software, such as Watson™ LIMS, LabNotes™ ELN, Nugenesis™ SDMS and Laura™ CDS. When combined, these systems provide enhanced speed, efficiency and data security to support your data transfer and regulatory needs.
The Arcinova bioanalysis team are experienced in the development, validation, application and technology transfer of LC, UPLC, GC and ion chromatography based assays.
Inductively Coupled Plasma - Mass Spectrometry [ICP-MS]
ICP-MS allows for the rapid and sensitive quantification of elements in biological matrices or to assess elemental impurities in Active Pharmaceutical Ingredients (APIs).
Gas Chromatography - Mass Spectrometry [GC-MS]
GC-MS allows for the rapid and sensitive quantification of volatile drugs, metabolites and biomarkers in biological matrices.
Accurate Mass Spectrometry
Identification of unknowns, for example API impurities or drug metabolites, is a frequent challenge.
In Vitro Services
Arcinova can conduct in vitro testing of pharmaceuticals to support safety, efficacy or molecule selection.
Metabolite Identification Studies
The identification of drug metabolites is an essential part of the drug discovery and development process.