Aptuit’s Bioanalysis group provides dedicated expertise and practical support for our in-house integrated preclinical packages for drug development. We also provide supporting bioanalysis for study samples derived from toxicokinetic studies. Bioanalytical laboratories are GLP accredited and validations are performed in accordance with OECD and FDA guidelines.
Our capabilities to support Preclinical Bioanalysis include:
- High capacity qualitative and quantitative LC-MS/MS analysis on triple quadrupole and linear ion trap mass spectrometers.
- Robotic automation for high throughput sample analysis.
• Fully integrated bioanalytical LIMS system.
- 24/7 sample receipt management and extensive storage capabilities at –20ºC and –80ºC.
- Scientifically trained report writers who work directly with our scientists to ensure quality reports to meet your deadlines.
Preclinical Bioanalysis services include:
- ADME Support - Rapid generic “fit for purpose” method development and sample analysis support for discovery lead optimization PK/PD studies. Provides discovery support for unaudited feasibility studies and limited validation GLP audited studies.
- Pharmacology/Toxicology Support - Rapid bioanalysis of plasma samples to provide PK/PD correlations to assist in lead candidate selection. Support of safety pharmacology and toxicology studies using validated methods to assess stability in vehicle, provide proof of exposure, and allow PK/PD correlation of results.
- Immunoassay Services - Specific assays to analyse peptide/protein therapeutics, protein biomarkers and antitherapeutics/neutralizing antibodies. Assay validations are performed to current FDA guidelines and best practice for ligand-binding assays.
- In Vitro Support - Inhibition of cytochrome P450 enzymes by candidate drugs, induction of cytochrome P450 enzyme activity and metabolic stability.