BIOANALYTICAL LABORATORY – WHO WE ARE
As part of the Initiative of Excellence – Research University Program at the Medical University of Gdańsk, a new core facility was established – the Bioanalytical Laboratory, whose main goal is to cooperate with research teams of the MUG and UCC 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 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 offers 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.
In October 21 the Bioanalytical Laboratory received 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 Bioanalytical Laboratory, 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) are mainly performed by using high performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Analyses of biomolecules (peptides, proteins, monoclonal antibodies) focus mainly on the use of immunological tests (ELISA).
Detailed description of the services provided
- 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 Centre 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)
The Bioanalytical Laboratory 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.
GLP Certificate
The Bioanalytical Laboratory of the Medical University of Gdańsk – a unit established under the Excellence Initiative – Research University program, operating at the Department of Biochemistry holds the Certificate of Good Laboratory Practice.
GLP certificate is a confirmation of a high level of quality and reliability of conducted research. Moreover, it authorizes the Laboratory to conduct preclinical and clinical research, which must be carried out in compliance with GLP standards.
GLP Certificate (64.3 KB)
Bio Lab Team: Paweł Olszewski, M.Eng., Bartłomiej Łukasz Ph.D., Agata Mechlińska, Eng.D., Katarzyna Smug M.Sc., Prof. Ryszard Tomasz Smoleński, photo Paweł Sudara/MUG
Contact
Bioanalytical Laboratory in the Department of Biochemistry
Paweł Olszewski
Lab Coordinator
Phone: 58 349 14 60
+48 661 601 104
biolab@gumed.edu.pl
TEAM
Prof. Ryszard T. Smoleński
– since 1980, associated with the Medical University of Gdańsk, currently Head of the Department of Biochemistry
– more than 30 years of experience gained at home and abroad in research on nucleotide metabolism and energy metabolism in the heart
– involved in the development of new therapies and research using genetic models of human diseases
– involved in the development of new analytical methods based on the LC/MS-MS technique
– involved in clinical studies of disease mechanisms and identification of new biomarkers.
Paweł Olszewski M. Eng. – laboratory management specialist
– since 2011 management of a GLP/GMP certified analytical laboratory providing bioanalytical services for preclinical and clinical studies (bioequivalence, phase I-IV studies) and analytical services for the pharmaceutical industry
– since 2003 – inextricably linked with the pharmaceutical industry, biotechnology and clinical research
Prof. Michał Markuszewski
– affiliated with the Medical University of Gdańsk since 1990, currently Head of the Division of Biopharmacy and Pharmacokinetics
– More than 20 years of experience gained at home and abroad in the field of pharmaceutical analysis, drug chemistry, pharmacokinetics, and biopharmaceutics, as well as in toxicological expertise
– involved in the development of new analytical methods based on LC-MS and GC-MS techniques
– planning and participating in studies on non-targeted qualitative analyses by fingerprinting/footprinting technique in diverse biological material: biological fluids e.g. blood plasma, urine; tissues e.g. cancer tumors; cell cultures, etc., as well as targeted analyses of selected compounds e.g. fatty acids
Agata Mechlińska Eng.D. – quality management specialist
– since 2012 – working with quality assurance systems (GMP, ISO-17025, GLP): coordinating and participating in quality processes (investigations, corrective and preventive actions, change control, deviations, complaints, audits); developing, checking, implementing, updating and supervising Standard Operating Procedures (SOP)
– experience in planning bioanalytical and analytical studies, controlling the experimental part of the studies, data management, ensuring consistency of documents and records with GLP/GMP requirements and regulatory (EMA/FDA/ICH)
Katarzyna Smug M.Sc. – analytical specialist
– since 2008 – work related to chemical analysis of drugs using high-performance liquid chromatography (HPLC) and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in a certified laboratory, in particular: development and validation of analytical methods, transfer of methods and their optimisation, extraction of samples using various techniques (PP, LLE, SPE, etc.), development and creation of test procedures and instructions, solving equipment problems. ), development and production of test procedures and manuals, troubleshooting of equipment, participation in proficiency tests, and inter-laboratory comparisons (with positive results)
– six-month experience in a certified foreign laboratory: performing environmental analyses (soil, water, fuels) by tandem mass spectrometry (LC-MS/MS) and by ICP-OES absorption emission spectrometry, supervision of research staff, participation in method validations
Katarzyna Owczarek Eng.D. – analytical specialist
– since 2019 – work in analytical laboratories operating in GMP and GLP systems in the pharmaceutical sector. Experience in particular working with tandem mass spectrometry coupled to gas chromatography and high performance liquid chromatography techniques and conducting research focused on trace analysis, substantive supervision of a research and development project, analytical method development, validation and transfer
– an internship at Monash University, Melbourne, involving participation in a project based on the use of the LC-MS/MS technique for the determination of bioactive phenolic compounds in food
– since 2013 – participation in many scientific and research and development projects undertaken as part of the doctoral dissertation, which included the use of biotests, the development of modern analytical methods and miniaturized techniques for preparing samples for analysis, used to determine trace amounts of xenoestrogens in various types of biological matrices