NAME 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.

FIELDS OF APPLICATION

Biomedical consumables

In-Vitro diagnostics

Laboratory equipment

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • 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.

  • 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.

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