Good Clinical Laboratory Practice (GCLP)

The PBRU has access to state-of-art GCLP laboratories, which have been set up to ensure that clinical trial samples are stored,  tested and the data analysed to rigorous GCLP standards as required by Good Clinical Practice and associated legal regulations.  The PBRU has made a substantial capital investment to help expand the GCLP laboratory by refurbishing the freezer room containing the Biobank, microbiology laboratory, molecular biology laboratory, instrument room and offices. The GCLP laboratory has a wide range of equipment including: Applied Biosystems SCIEX QTrap 5500 mass spectrometer with Ultimate 3000 Dionex LC system, luminex analytical system for cytokine analysis, Roche 480 light cycler real time PCR machines, B&D FACSCANTO 6 colour analyser, pharmagraph, Laboratory Information Management system (LIMS) system and ultra low temperature freezers.

The GCLP laboratory has set up a range of bioassays to GCLP standards, including: indirect and direct proliferation assays using thymidine incorporation; quantitation of cytokeritin cleaved/uncleaved 18 levels by ELISA; cytokine analysis using the luminex system and ELIspot; quantitative PCR; tissue micro arrays; antibody validation. These assays have been employed for testing clinical trial samples from pancreatic patients recruited into the Telovac, ESPAC-4 and ESPAC T+ Proteomic workflows for relative quantification by iTRAQ and mass spectrometry are also being developed.

The GCLP Mass spectrometry & GCLP Tissue Culture laboratories







 The GCLP laboratory has set up sophisticated systems to control and audit the storage and release of samples, execution of bioassays and analyze data, using the Laboratory Information Management System (LIMS) and version controlled SOPs. These processes are closely monitored by the Quality Assurance Manager. An in-house GCLP training programme is in place to ensure continuous experimental training and development for LECMC GCLP and PBRU Research staff.

The PBRU has appointed a mass spectrometry Senior Scientist and Bioinformatics Senior Scientist  to develop proteomic protocols to be used at GCLP for the identification and analysis of biomarkers. We are also devising Bioinformatics analytical systems for gene arrays to GCLP.







For futher details regarding GCLP at the University of Liverpool please click on the link to their website.