WHO WE ARE
As part of the Initiative of Excellence – Research University Program at the Medical University of Gdańsk, a new core facility is being created – the Center of Bioanalytics, whose main goal will be to cooperate with research teams of the MUG and UCK by supporting the process of scientific research and clinical trials in the field of analytics and bioanalysis, especially in the context of Priority Areas Research (oncology, cardiology and cardiovascular medicine as well as biochemistry, genetics and molecular biology). The Centre will employ analysts and bioanalysts, whose work will strengthen the interdisciplinary nature of research, development and implementation work carried out at the MUG and will enable the implementation of the above projects by external entities.
The core facility will offer an integrated portfolio of Good Laboratory Practice (GLP) certified analytical and bioanalytical services at all stages of the drug development process – from preclinical testing (ADME), through bioequivalence (BE) and pharmacokinetics (PK) to clinical trials (including statistical calculations) to drug registration support. The activity profile will include: qualitative and quantitative determination of compounds and their metabolites in biological samples of human or animal origin, such as: plasma, serum, whole blood, urine, saliva, feces, tissues, etc.
The Center of Bioanalytics will have a Good Laboratory Practice (GLP) certificate, which confirms the high level of quality and reliability of the tests carried out in the Laboratory. Thanks to this, the results of analyses obtained at the Centre will be recognized around the world by all offices and institutions, such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
RANGE OF SERVICES
Overview of the services provided
The Center of Bioanalytics, in addition to direct participation in the implementation of the entrusted research, offers MUG employees and doctoral students, as well as external units the opportunity to discuss the optimal approach to the project in terms of appropriate pharmacokinetic assumptions, necessary analyses, or the selection of appropriate analytical methods.
Small molecule analyses (up to 1000 Da) will mainly be performed using high performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Analyses of biomolecules (peptides, proteins, monoclonal antibodies) will focus mainly on the use of immunological tests (ELISA).
- consultation on the clinical trial design, including pharmacokinetic, bioavailability and bioequivalence analyses,
- development and validation of bioanalytical methods for the determination of the drug and/or its metabolite/s in a biological matrix in accordance with the EMA/FDA guidelines, completed with a validation report,
- transfer or cross-validation of bioanalytical methods developed outside the laboratory,
- sample preparation (including post-sampling pre-treatment if necessary),
- sample analysis, completed with an appropriate analytical report,
- substantive consultations leading to the analysis of pharmacokinetic parameters (for all routes of administration, regardless of the dosing schedule), including specialized statistical calculations (WinNonlin) – also in cooperation with the Center of Biostatistics and Bioinformatics Analysis and supporting experts,
- substantive consultations leading to the preparation of the final report containing parts: analytical, pharmacokinetic and statistical (CTD format, module 5).
Detailed description of the services provided
The Center of Bioanalytics will carry out research according to individual projects as well as the ideas of the ordering person, both as part of service activities and participation in a research project.
Center of Bioanalytics
Medical University of Gdańsk
Dębinki 1 Street
Phone: 58 349 14 60
+48 661 601 104