Clara Bilbao

Safety of medical devices and topical medications

GAIKER leads the development of alternative methods for for assessing the safety of medical devices and drugs

At GAIKER, we are proud to offer advanced, ethical solutions regarding the safety of healthcare products and drugs. We carry out state-of-the-art in vitro and ex vivo studies to assess the safety of these products at various stages of their development, from pre-clinical to clinical phases. This approach allows us to detect potential risks early, thereby ensuring the safety and efficacy of products for the end consumer.

One of the cornerstones of our work is biocompatibility, which we assess without the need for animal testing. This approach not only helps minimise the use of animals in experimentation, but also contributes to the development of more ethical alternative methods, in line with the principles of the 3Rs (replacement, reduction and refinement).

We have state-of-the-art tools and equipment that enable us to provide a wide range of tests that are adapted to customer needs:

  • Safety tests
  • Cytotoxicity tests
  • ADME-tox studies covered by a guarantee of good laboratory practices (GLPs)
    • Absorption
      • Skin absorption (OECD 428). Franz Diffusion Cells
    • Organ-specific toxicity
      • Organo-specific toxicity tests
    • Toxicity mechanisms
      • Tailor-made tests: apoptosis/necrosis, oxidative stress, inflammation, DNA damage, intracellular calcium, etc.
    • Genotoxicity
      • Ames test (OECD 471)
      • Mutagenicity in mammalian cells (OECD 476)
      • Micronucleus test (OECD 487)
    • Eye tests
      • Eye irritation and damage (OECD 492, Het-Cam)
    • Skin tests
      • Skin corrosion/irritation (OECD 431, OECD 435, OECD 439)
      • Phototoxicity (OECD 432)
      • Oral, nasal, vaginal and gingival irritation

More information – info@gaiker.es

We are researching new solutions to boost the circular economy in renewable energy

The CICLO Transmissions project focuses on developing technological solutions for recycling and recovering composite materials that are used to build wind turbines.

Currently, 83% of the materials that make up a wind turbine can be recycled or reused. However, blades are extremely challenging because of their heterogeneous composition and the fact that they contain materials that are difficult to treat and separate properly using conventional recycling processes. The CICLO project (2025-2028) has been created with the aim of providing a solution to this challenge. Eight companies and six research centres are taking part in this project, including the GAIKER Technology Centre, which is a member of the Basque Research & Technology Alliance (BRTA), and coordinator of the AEI consortium.

The main goal of this project is to conduct research into new technological solutions to boost the circular economy in the field of renewable energy, specifically for recycling and recovering blades and other composite components used to build wind turbines, such as nacelles, electrical cabinets, etc. at the end of their life cycle. In addition, research will be carried out into the development of alternative materials that are easier to recycle compared to existing materials, in the form of recyclable polymer matrices.

The project aims to optimise the recovery of fibres and by-products from thermal and chemical recycling, so that at least 90% of the recycled fibre is recoverable and the efficiency in the recovery of by-products from recycling exceeds 75%. It also aims to reduce the formation of organic pollutants in thermal processes by 50% and to improve the enzymatic degradation of epoxy resin, polyester and polyurethane. These developments will strengthen the sustainability and efficiency of composite recycling and promote the creation of second-generation structural materials with a 100% recycled content, integrating high percentages of recycled fibres.

GAIKER, as an expert in sustainable composites and recycling and circular economy, is coordinating the project’s AEI consortium, and will be in charge of researching technologies for remodelling, joining and functionalising fibre-reinforced composite plates extracted from the blade for new applications. It will also explore chemical recycling processes to recover reinforcement fibres and polymer matrices, including recycled reinforcement fibres in BMC and SMC intermediate products and seeking alternative material recovery of liquids from such recycling for the formulation of new resins. Research will also be carried out into the recovery of lightweight blade components (foams and balsa wood) by developing a new generation of lightweight cores and new recyclable and sustainable high-performance composites, using infusion technology, which also incorporate recovered fibre and lightweight cores.

Subsidised by the Centre for the Development of Industrial Technology (CDTI by its Spanish acronym) and backed by the Ministry of Science and Innovation within the Transmissions 2024 Programme (PLEC2024-011215), CICLO, using an integrated approach that includes separation, extraction, recycling, formulation and processing, aiming to recover practically 100% of composite materials.

Project PLEC2024-011215 funded by MICIU/AEI/10.13039/501100011033 and by ERDF, EU.

We are committed to AI to transform the design and manufacturing processes of composite aerostructures

The European pAIramid project will develop a virtual testing platform that will guide the design and processing of composite materials in the characterisation pyramid.

The GAIKER technology centre, a member of the Basque Research & Technology Alliance, BRTA, is participating in the European project on 'Al-based testing pyramid virtual certification of next-gen composite aerostructures', pAIramid.

This research, which began in 2024 and will last for 45 months, aims to advance tools and methodologies based on artificial intelligence (AI) to transform the design and manufacturing processes of aeronautical composite structures, using sustainable thermosetting and functionalised thermoplastic resins.

The aerospace industry faces major challenges when it comes to certifying composite aerostructures, as it is a complex and costly process based on the traditional pyramid framework, in which each level undergoes labour-intensive sequential testing from materials to complete aerostructures.

In order to provide a solution to these challenges, pAIramid will create a virtual testing platform to guide the design and processing at all levels of the characterisation pyramid (from the material specimen, the element, the component and the complete structure), optimising virtual certification, accelerating innovation and improving design decision-making. The project will also develop functionalised thermoset and thermoplastic resins and optimise the LRI (Liquid Resin Infusion) and FDM (Fused Deposition Modelling) manufacturing processes for the cost-effective and scalable production of complex functionalised parts..

This innovative approach seeks to replace costly physical testing with high-fidelity simulations and data-driven insights, making certification a more streamlined, efficient and connected process.

pAIramid involves 13 strategic partners from seven different countries, including GAIKER, an expert in the formulation and design of composites, whose role focuses on the development of functionalised thermoset resins and their characterisation for use in two of the four aerospace case studies in the project: in the structure of the aircraft door and in the front edge of the wing.

As part of the European Union's HORIZON programme, this research represents a crucial step towards the digital transformation of the European aerospace industry, setting a new standard for the development of more sustainable and efficient aircraft.

Project partners

The pAIramid project is made up of a consortium that includes research and technology centres, such as IKERLAN S. Coop. (project coordinator), GAIKER, IRT Jules Verne and INEGI, as well as prestigious universities, such as the University of Girona and Brunel University London. It also has industrial partners from the aerospace sector, such as Collins Aerospace-RTX, Turkish Aerospace, POTEZ Aeronautique and SOFITEC Aero, and companies specialising in consultancy and technological services such as MECA, LKS Next and Zabala Innovation Europe.

More information: https://pairamid.eu/

This project has received funding from the European Union's Horizon Europe research and innovation programme under grant agreement No. 101192736.

GAIKER develops new technologies for the contactless monitoring of composite materials

The MOSINCO project will improve the way composite parts are manufactured and maintained, leading to better quality control, safety and traceability.

The GAIKER technology centre, a member of the Basque Research & Technology Alliance (BRTA), is leading the MOSINCO project, the main aim of which is to develop new technologies to allow the contactless monitoring of composite materials, from the manufacturing process to the end of their useful life. Its ultimate goal is to ensure the quality, safety and traceability of parts, while reducing defects, maintenance costs and waste.

The aim of this research is to open the door to a new generation of smart composites with self-diagnostic capabilities and optimise their maintenance so as to avoid routine, costly inspections. The idea is to improve the manufacturing efficiency and structural properties of parts, using less material. To achieve this, work is being done on developing and integrating three technological lines. First, magnetic microwires embedded in the materials are used to detect deformations, stresses and strains and temperature changes. Second, air-coupled ultrasound (ACU) are used to detect defects and evaluate the curing of the material during manufacture. And finally, functional inks, which change colour with temperature, making it possible to control the curing process or unequivocally identify each part. The potential of these three technologies is analysed in the project both individually and by identifying the possible synergies between them.

Funded by the Basque Government as part of its ELKARTEK 2024 programme of aid for collaborative research in strategic areas, MOSINCO involves six different entities including Autotech (Gestamp), BCMaterials, EHU, Ideko, the University of Deusto and the GAIKER Technology Centre, which is responsible for coordinating the consortium's activities, ensuring that the technologies are aligned with the needs of industry. The centre is also working on developing and validating new sensorised materials and will ensure that monitoring systems are integrated throughout the life cycle.

This research represents a qualitative leap in the way composite parts are manufactured and maintained, as these new technologies will improve quality control, thereby reducing defects and waste, safety and reliability for sectors such as aeronautical and automotive industries. Ultimately, it will be a step towards a smarter, more efficient and sustainable industry.

Subsidised by the Basque Government

ONTZHI-II launch: Key technologies for storing and transporting hydrogen

The second phase of the ONTZHI project was presented in Zamudio, following the progress made in the first phase: ONTZHI-II. The project is aimed at developing innovative technologies to allow hydrogen to be stored and transported in a safe, sustainable and competitive manner, which will be an essential step in the transition to a decarbonised economy.

GAIKER Technology Centre, a member of the Basque Research & Technology Alliance (BRTA) is involved in this project, which focuses on responding to one of the major strategic challenges of the energy transition: deploying infrastructures to ensure the safe and efficient handling of hydrogen, which is considered to be a key energy vector for reducing emissions and moving towards climate neutrality.

ONTZHI-II is funded by SPRI, through the Elkartek programme, and has an overall budget that will allow it to carry out its work between 2025 and 2027. During this period, it is expected that key milestones will be achieved, such as the validation of advanced coatings, the construction of laboratory-scale demonstrators and the development of a predictive computational model to facilitate the transfer of results to the industrial sector.

While hydrogen has great potential as a clean energy source, it also poses challenges that currently limit its deployment. These include the embrittlement of steel and welds in pipelines and tanks, the lack of in-depth knowledge about the interaction of hydrogen with different materials, permeation and leakage in storage systems, and the need for composite tanks that are both competitive and sustainable.

ONTZHI-II will investigate new solutions to overcome these barriers, such as:
• Advanced coatings on metals to prevent embrittlement and reduce leaks.
• Developing sustainable and recyclable composite materials for mobility applications.
• Modelling and characterisation methods capable of predicting how hydrogen will interact with materials.

This project also aims to build two laboratory-scale demonstrators: a barrier coating against hydrogen permeation and a type IV tank made of sustainable composite materials, intended for mobility and designed for reuse.

A top-flight consortium
ONTZHI-II is a consortium made up of six strategic partners: Tecnalia, which is leading the initiative, together with the Basque Country Mobility and Logistics Cluster, GAIKER, Cidetec, Tekniker and Multiverse Computing. The collaboration between these entities will combine cutting-edge capabilities in research, industry, advanced manufacturing and computing, making it possible to tackle the main hydrogen technology-related challenges.

GAIKER
GAIKER's work within this project will focus on research into reactive thermoplastic or bio-based resins for use in both interior linings and composite tank casings intended for storing hydrogen in a gaseous state for mobility applications. The technology centre will use 3D printing, RTM and taping technologies to focus its efforts on developing hollow structures that can be adapted to the available space and that also facilitate end-of-life and recycling by using materials of the same type throughout the tank structure.

The Basque Country, a strategic region for hydrogen
The choice of the Basque Country as the headquarters of ONTZHI-II is no coincidence. The region has a robust industrial base, a top-level scientific and technological infrastructure, and an energy strategy committed to decarbonisation. These factors make it an ideal environment for developing and scaling up hydrogen-related solutions and increasing the competitiveness of its companies in an expanding global market. The launch of ONTZHI-II will strengthen the Basque Country’s position in terms of creating a leading hydrogen technology ecosystem. The project will help provide safer solutions for critical infrastructures, which will be more sustainable as a result of recycling and reusing materials, and more competitive by promoting industrialisation and positioning local companies in the hydrogen value chain.

GAIKER leads the E-OilÉ project to develop sustainable single-dose packaging

The E-OilÉ project, which is funded under the Horizon Europe programme, has been launched to develop pioneering single-dose packaging solutions that are safe, sustainable and biodegradable for fatty products in the food and cosmetics sectors.

The GAIKER Technology Centre, a member of the Basque Research & Technology Alliance (BRTA), is leading the E-OilÉ project, which is funded under the Horizon Europe programme and began last June, with the aim of tackling one of the most persistent environmental challenges today: plastic packaging waste. This research involves 15 partners from across Europe working to develop biodegradable, functional packaging specifically designed for fatty products such as olive oil, sauces, body oils and cosmetic serums.

Single-dose packaging is in high demand by consumers as it is safer and more hygienic, but it poses significant challenges in terms of conventional end-of-life (EOL) recycling systems, due to its small size, the complexity of the materials used and the risk of contamination of other recycled plastic streams. E-OilÉ is looking to provide innovative solutions by developing biodegradable alternatives that comply with existing standards and guidelines, ensuring that they do not compromise biodegradability or hinder existing recycling processes.

Traditional plastic packaging has a high environmental cost as it contributes to landfill, marine pollution and greenhouse gas emissions. Even today's bioplastics often fall short of expectations: they degrade too slowly under real-world conditions, do not meet the requirements for food-grade applications, or rely on raw materials imported from outside Europe.

E-OilÉ establece un nuevo estándar aplicando los principios de sostenibilidad desde el diseño (SSbD- Safe and Sustainable by Design) a lo largo de todo el ciclo de vida del producto. El proyecto utilizará materias primas renovables, en este caso derivadas de subproductos de la oliva, para crear poliésteres biodegradables y mezclas a base de polisacáridos, diseñadas para cumplir con exigentes requisitos funcionales y medioambientales.

Los nuevos materiales serán validados en procesos industriales de fabricación de envases como extrusión soplado de films, moldeo por inyección y termoformado, y los prototipos serán sometidos a pruebas completas de biodegradabilidad, evaluaciones de riesgos medioambientales y de salud, y estudios de aceptación por parte de los consumidores, para garantizar su aptitud para entrar en el mercado.

Moreover, this project will use digital twins and AI-based tools to predict degradation performance, accelerate optimisation, and reduce testing costs, thereby helping to speed up the implementation of sustainable packaging innovations.

E-OilÉ is looking to provide safe, low-cost, market-ready alternatives that meet both performance and sustainability requirements.

“In the E-OilÉ project, we are rethinking the concept of packaging. It is not only about how it is manufactured, but also about its performance against complex products such as oils, its ability to biodegrade in real environments and how to make use of by-products that are readily available in Europe from olive-related agricultural activities to develop smarter, safer, more sustainable materials that will drive a circular future", said María José Suárez (GAIKER), the project’s coordinator.

GAIKER in E-OilÉ
GAIKER, a technology centre that specialises in sustainable materials, waste recovery and innovative solutions involving plastics and coordinates the E-OilÉ project, will be responsible for validating biodegradable materials and packaging at a functional level, and redesigning them prior to industrial scaling. Following Life Cycle Assessment and Life Cycle Costing (LCA and LCC) methods, it will also study the sustainability and circularity of the proposed biodegradable packaging solutions and their potential recyclability.

Project partners
The E-OilÉ project will last for 4 years and involves representatives across the entire value chain of the project: material manufacturers such as NOVAMONT SPA and OIMO BIOPLASTICS, S.L.; packaging manufacturers such as UGRINPACK KFT, CTLPACKGROUP S.L. and PROPAGROUP SPA; end users from the food and cosmetics sectors such as DESMELIS ATHANASIOS and AHAVA, and companies responsible for social impact and the communication, dissemination and exploitation of results such as HOLOSS, ILSI and PNO INNO INNOVATION. Other companies supporting the industrial partners in the technical developments of E-OILÉ include: GAIKER (characterising and improving the performance of materials, LCA, LCC and recyclability), ITENE (processability and characterisation, and leading SSBD activities), CNTA (validating products packaged in new materials), DTI (biodegradation and end of life) and NORCE (AI modelling of biodegradability processes).

“Designed to be biodegradable, created to be sustainable”.

This project has received funding from the European Union's Horizon Europe research and innovation programme under grant agreement no. 101177771.
The views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them.