We leverage state of the art facilities, equipment and processes, including Ultra Performance Liquid Chromatography equipped with various detectors such as UV-Vis, Fluorescence, Electrochemical, mass spectrometry (UPLC/MS/MS) and gas chromatography. Our method development, validation and sample analysis offering is best in-class for bioanalysis studies supporting preclinical and clinical trial in compliance with GLP.
When required, we can develop sensitive and specific immunoassays to support studies of macromolecule for pharmacokinetics, biomarkers and immunogenicity studies. Our development process of bioanalytical methods is tailored to meet specific needs of bioanalysis while direct, indirect, sandwich and competitive ELISA assay are available.
Our scientists have extensive experience developing and validating bioanalytical methods in different biological matrices including whole blood, plasma, serum, urine and various tissues to support pre-clinical studies and clinical studies (Phase I-III). Our bioanalytical services are performed in compliance with GLP and comply with Health Canada and U.S. FDA guidelines.
Our Bioanalytical testing services include:
- Assay method development, validation and transfers
- Expertise in many validated methods to quantitatively measure all types of compounds, small or large molecule, using:
- UPLC/MS/MS, TQD and Xevo TQ-S Triple Quadrupole Mass Spectrometers
- Xevo G2
- HPLC – GFC
- UPLC-UV, FLR, ECD
- Metabolite identification using UPLC-Q-TOF or UPLC/MS/MS
Pre-clinical trial support
- Bioanalysis of drug and metabolites in biological fluids
- Sample analysis in multiple biological species and matrices for human and animal studies
- Toxicokinetics (TK)
Clinical trial support
- Pharmacokinetics (PK)
- Bioavailability studies
- Bioequivalence studies
- Drug Interaction studies
- Biomarker study
Large molecule analysis
- DNA, RNA
- Fatty acids and phospholipids profile