NAME Biomaterialen eta gailu medikoen karakterizazio- eta segurtasun-laborategia

DESCRIPTION

25 urtetik gorako esperientziarekin, laborategia biomaterialen, gailu medikoen (in vitro eta ex vivo) eta boluntarioen ebaluaziora eta segurtasunera bideratuta dago. Batez ere toxikotasunaren, ADMEaren eta karakterizazio biologikoaren esparruan garatzen du bere jarduera. Laborategian biobateragarritasun-saiakuntzak egiten dira, ISO-10993 arauaren arabera. Laborategiek Espainiako Osasun eta Kontsumo Ministerioaren akreditazioa dute Laborategiko Jardunbide Egokien (BPL) pean lan egiteko, farmakoentzat eta osasun- eta higiene-produktuentzat. Halaber, material eta gailu medikoen karakterizazio biologikoari buruzko azterlanak garatzen ditu plataforma honek.

FIELDS OF APPLICATION

Biomedical consumables

In-Vitro diagnostics

Laboratory equipment

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • Molecular biology and proteomics equipment

    DNA and RNA extraction robot; automated PCR robot and thermocyclers (6 real-time PCR), electrophoresis, Geldoc, modules for two-dimensional gels, as well as Illumina MiSeQ sequencer.

  • Cell biology equipment

    4 laminar flow cabinets, 5 incubators with CO2 and temperature control. As well as, installation to work with viruses and to be able to carry out studies to determine antiviral properties. Flow cytometry unit, multimodal plate reader (Varioscan) and analytes analyzers using Luminex technology. They are accredited by the Ministry of Health and Consumption to work under GLP for drugs and sanitary and hygiene products.

  • Chromatographers

    Gas chromatography with all types of detectors and liquid chromatography with HPLC and UPLC triple quadrupole (mass/mass). It also has the ICP that allows elemental detection in ppbs.

  • Microscopy

    Fluorescence, confocal and scanning electron microscopy.

SERVICES OFFERED BY THE ASSET

Biological and functional characterization

Characterization and in vitro validation of biomaterials and devices using all types of biotechnological tools (cell biology, proteomics, genomics, etc.), specifically to the gastrointestinal, respiratory, dermal, nervous and immune systems. These models have high predictive power and low cost allowing the industry a fast and efficient evaluation of their products.

Security

Biomaterial consumablesRegulatory studies to ensure the safety of biomaterials and medical devices according to ISO 10993 and under GLP. Cellular cytotoxicity, irritation, intracutaneous reactivity, genotoxicity, hemocompatibility, corrosion, etc. As well as ecotoxicity studies according to ISO standards.

ENTITY MANAGING THE ASSET

ENTITY MANAGING THE ASSET
GAIKER
Contact person:
Felipe Goñi De Cerio
goni@gaiker.es