Biomaterials and medical devices characterization and safety laboratory.
DESCRIPTION
With more than 25 years of experience, the laboratory is focused on the evaluation and safety of biomaterials and medical devices in vitro, ex vivo and volunteers. It develops its activity mainly in the field of toxicity, ADME and biological characterization.
The laboratory performs biocompatibility tests under ISO-10993 standard. The laboratories are accredited by the Ministry of Health and Consumer Affairs to work under Good Laboratory Practices (GLP) for drugs and medical devices and hygiene products. The platform also carries out biological characterization studies of medical materials and devices.
MOST OUTSTANDING EQUIPMENT AND COMPONENTS
Cell biology equipment4 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.
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.
Fluorescence, confocal and scanning electron microscopy.
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.
SERVICES OFFERED BY THE ASSET
Biological and functional characterization
Security
ENTITY MANAGING THE ASSET
GAIKER
Contact person: Felipe Goñi De Cerio
