Pharmakokinetics Drug Metabolism Unit
The laboratory consists of PhD and MSc level analysts. The laboratory head in close collaboration with a quality assurance manager oversees a yearly training program for lab members, consistent with the ISO17025 standards and the recently initiated processes in order to fully comply with Good Laboratory Practice (GLP) guidelines. As many of the studies require administration of drugs into animal models a close collaboration/coordination is also required between our members and the management of the Experimental Surgery Unit-Animal Facility in order to ensure that all proper ethical standards are followed and the proper design is in place for dosing routes and sample collection procedures.
The laboratory’s main analytical equipment and strong expertise is based on Liquid Chromatography-Mass Spectrometry (LC-MS/MS) instrumentation. The continuous operation of instrumentation is secured by service contracts. The experience and expertise of the laboratory’s staff ensures that the scientific excellence follows and in many cases pushes the State of the Art in the field of bioanalysis.
An API 4000 QTRAP LC-MS/MS system fitted with a TurboIonSpray source and a hybrid triple quadrupole/linear ion trap mass spectrometer (Sciex)
An API 5500+ QTRAP LC-MS/MS system fitted with a hybrid triple quadrupole/linear ion trap mass spectrometer (Sciex) is also on order for the laboratory’s needs.
The laboratory is also equipped with other basic laboratory equipment required for these types of analyses (analytical balance, pipettes, centrifuges, evaporators, freezers) that are regularly (yearly) calibrated from an external certified service provider:
- Hood space for handling biological specimens, organic solvents and cell cultures
- Τriple quadruple/ion trap mass spectrometers with HPLC pumps
- HPLC System coupled with UV detector
- Freezers (-80 0C), refrigerators
- pH meter, analytical balance, centrifuges, evaporators
- IT support
- Available in vitro tools (e.g.,microsomes) for drug stability or metabolite identification studies
The laboratory offers the above mentioned service as part of the Center of the Clinical, Experimental Surgery and Translational Research of BRFAA in the context of laws governing the Institute’s objectives and mission. The laboratory follows the ISO17025 and GLP guidelines, and it has in place all the necessary standard operating procedures (SOPs) and certifications that are required for these types of analyses. In order to undertake a specific analytical study based on a specific request the laboratory takes the following necessary steps:
- Literature review (if the analysis requires a new method)
- Estimation of potential costs (personnel and consumables) – Proposal of a budget
- Instrument availability and assigned analysts
- Evaluation of the timeframes for the supply of materials, development and validation of method (if needed), execution of the analyses
- Contract with description of specific terms signed by BRFAA board