In vitro testing is an extremely important part of the process of evaluating the safety and efficacy of medical devices, new drugs, medicinal products or other substances before they are put on the market. The term “in vitro” refers to laboratory experiments conducted outside a living organism, as opposed to “in vivo” studies, which take place in living organisms such as laboratory animals or humans.
In vitro testing is crucial in assessing the potential adverse effects and toxicity of medical devices, drugs, medicinal products or other substances as well as their efficacy. One of the main aspects governing in vitro testing is the principle of Good Laboratory Practices (GLP), which is an international standard that ensures reliability, consistency and precision of results. With GLP, in vitro tests are conducted according to well-defined procedures and documented in detail, enabling reproducibility of results.
During in vitro testing, cells or tissues are exposed to chemicals, medical devices or drug products and then monitored to assess whether they produce the desired therapeutic effects or potential adverse effects. This approach allows researchers to identify potential risks and improve the efficacy of products before they reach the market. In vitro testing also allows for the study of the mechanisms of action of medical devices at the molecular level, which is key to understanding their effects on the body.
In conclusion, in vitro testing is an indispensable step in the process of evaluating medical devices, medicinal products, chemicals allowing for a meticulous study of their properties and effects on the body, in accordance with GLP principles, which contributes to ensuring the safety and efficacy of medical products available on the market.
In the Silesian Park of Medical Technology Kardio-Med Silesia in vitro tests are performed in a modern cellular laboratory. It is equipped with specialized equipment for various types of research, including a flow cytometer, Zeiss Axio Zoom.V16, Zeiss Axiovert, Zeiss Axio Observer with incubation chamber and Zeiss Primovert microscopes enabling observation and photo documentation of cultured cells, Tecan Spark multifunctional reader, autoMACS® Pro cell sorter.
The laboratory also has apparatus that allows analysis of enzymatic activity of cells and determination of protein expression and secretion (e.g.: ELISA immunoenzymatic assays, western blot). Access to a cryogenic storage system with liquid nitrogen and -20oC and -80oC freezers allows banking and storage of cells and biological samples.
In the Silesian Park of Medical Technology Kardio-Med Silesia in Zabrze is certified for Good Laboratory Practice in the biocompatibility part (scope 9) for biological evaluation of medical devices for tests such as in vitro cytotoxicity. We also perform in vitro tests without GLP certification confirmation but with the highest quality standards.
Feel free to contact us to match the appropriate testing method to your medical device.
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