Screening to Fully Validated GLP Bioanalysis
Our bioanalytical services expertise provides quantitative measurements on a range of active drugs, from small molecules to peptides, as well as metabolites. We can perform analysis in the most basic buffer matrices or complex biological matrices such as plasma, serum, urine, feces, bile, and tissue. All Bioanalytical projects, from the simplest sample preparation and analysis to the most complex method validation, are approached with a focus on accuracy, precision, efficiency, and speed.
- Waters Xevo TQ-S
- Thermo Scientific LTQ Orbitrap XL
- AB Sciex 4000 QTRAP
- AB Sciex API 4000
- Waters Acquity UPLC
- Leap CTC Analytics Autosamplers
- Tomtec Quadra 96 robotic sample prep workstation
- Conventional HPLC with UV detection
- Fluorescence detectors
- Scintillation counters
All Studies Supported
- Clinical Bioanalysis
- GLP Bioanalysis
- Non-GLP Bioanalysis
- Method Development
- Metabolite Identification
We offer a full range of bioanalytical services supporting drug discovery to all stages of clinical phases to pinpoint the detection of your compound
We offer GLP and non-GLP method development and sample analysis, with the rigor required to satisfy regulatory agencies. We routinely provide bioanalysis for ADME screening, preclinical pharmacokinetic (PK), toxicokinetic (TK) studies, metabolite identification, and GLP bioanalysis of plasma samples from human clinical trials. We can now offer radioactive drug detection. Our labs are equipped with 21 LC-MS/MS systems, allowing for analysis of thousands of samples a day. We can handle projects ranging in size from a few to several thousand of samples.
Validation of bioanalytical methods follows the May 2018 U.S. Food and Drug Administration (FDA) “Guidance for Industry: Bioanalytical Method Validation” and the Absorption Systems Standard Operating Procedure (SOP) “Validation of Quantitative Bioanalytical Methods for Determination of Test Compounds and/or Their Metabolites in Biological Matrices.”
GLP bioanalysis also follows the FDA Good Laboratory Practices (GLP) regulations (21 CFR Part 58) and the OECD Principles of Good Laboratory Practice. In addition, all studies follow our own relevant SOPs.
Electronic Reporting and Documentation
LC-MS/MS data is generated using Analyst® Version 1.6.3 compliant with 21 CFR Part 11, and all customer reports are archived in a validated eQCM by Xybion database compliant with 21 CFR Part 11.
- Mini Pig