Biotechnological and Analytical Laboratories
Biomedical Research Center, Slovak Academy of Sciences
Šarišské Michaľany
BASIC INFORMATION
Biotechnological and Analytical Laboratories (BTL) are part of the Biomedical Research Center of the Slovak Academy of Sciences at its detached workplace in Šarišské Michaľany.
The main mission of the BTL is:
- Development and introduction of novel approaches for the preparation, formulation, characterization and analysis of biologically active macromolecules and multi-component substances of biological origin for therapeutic, preventive and diagnostic purposes,
- Transfer of knowledge from applied research and development of bio-pharmaceuticals into practice with efficient use of modern infrastructure.
By creating BTL, the Slovak Academy of Sciences and the biomedical scientific community gained unique modern laboratories for applied research and innovation in the field of biopharmaceuticals development, which meet the requirements for working under strictly aseptic conditions according to the criteria of Good Manufacturing Practice (GMP) in pharmacy.
BTL consists of Research and Development Laboratories and Analytical Laboratories.
RESEARCH AND DEVELOPMENT IN BIOTECHNOLOGY AND ANALYTICAL LABORATORIES OF THE BMC SAS
The individually designed facilities in the Research Laboratories with A/B and A/C purity class allow the implementation of research projects focused on:
- Therapeutic biopharmaceuticals produced in eukaryotic cells (growth factors, monoclonal antibodies);
- Novel more effective and safer viral vaccines;
- Substances of bacterial origin for therapeutic and diagnostic purposes;
- Final formulation of biopharmaceuticals with a focus on their stability and efficacy.
Key infrastructure in the BTL Research Laboratories includes bioreactors with cell perfusion culturing capabilities, CO2 incubators, large-capacity centrifuges, ultracentrifuges, low-speed centrifuges, laboratory fermenters, microbiological incubators, capreparative chromatography system, semi-automatic filling unit, filtration systems, microscopes, laboratory lyophilization equipment, freezers including deep-freezers and cryo-preservation system.
ANALYSES IN THE BIOTECHNOLOGY AND ANALYTICAL LABORATORIES OF THE BMC SAS
The BTL Analytical Laboratories develop and validate methods for determining the potency, composition, safety and purity of medical products and outputs from activities conducted in the BTL Research Laboratories. The analytical testing itself includes:
- physico-chemical analyses
- microbiological analyses
- virological analyses
- molecular biological analyses
For their activities, the Analytical Laboratories use equipment for infrared spectroscopy (IR), for atomic absorption spectroscopy (AAS), for the determination of total carbon (TOC), for the LAL test, for the determination of the melting point, a refractometer, various titrators, HPLC systems, various types of incubators, including CO2 or microbiological ones, cyclers for standard and real-time PCR, electrophoretic systems for the separation of nucleic acids or proteins, microscopes, particle counters, and other equipment.
BTL Analytical Laboratories holds the Good Manufacturing Practice (GMP) Certificate for control laboratories in the pharmaceutical industry.
KEY MEMBERS OF THE BMC SAS BIOTECHNOLOGY AND ANALYTICAL LABORATORIES TEAM
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RNDr. Marta Miklošová – Head of BTL Analytical Laboratories
MVDr. Jana Struková – Head of Microbiology Section of BTL Analytical Laboratories
Ing. Mária Baranová – Head of Virology Section of BTL Analytical Laboratories
Ing. Veronika Genčúrová – Head of the Physicochemical Analysis Section of the BTL Analytical Laboratories
Mgr. Ondrej Ragač – Physico-chemical analyses and HPLC
Mgr. Soňa Sokolskáí – Microbiology
Mgr. Eva Miklošová – Virology