Biotechnology Basque Country

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Portfolio of biotechnology Opportunities in the Basque Country. Biochemtech Sector Group.
Digital edition also in ebook formats. www.spri.es/doc/biotechnology-portfolio

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Biotechnology Basque Country

  1. 1. Portfolio of Biotechnology Opportunities in the Basque Country BioChemTech Sector Group
  2. 2. 2
  3. 3. Portfolio of Biotechnology Opportunities in the Basque Country BioChemTech Sector Group 3
  4. 4. INDEX Index................................................ 4 Introduction..................................... 6 Technology Offers:HEALTH..............8 AJL OPHTHALMIC SA (AJL)....................................................... 10 Design, development and manufacture of intraocular lenses and other medical devices BIAL..................................................................................... 12 Recombinant Allergens BIOBIDE S.L,......................................................................... 14 Toxicity and efficacy assays of compounds through zebrafish animal model BIOFISICA FRET..................................................................... 18 FRET Amplified Signal Technology for Biomarker And System Evaluation- (FASTBASE) BIOFISICA OIT....................................................................... 22 Biofisika Open Innovation Platform (Biofisika-OIP) BIOFTALMIK.......................................................................... 26 Tear based diagnostic test for ocular diseases BRAINCO BIOPHARMA S.L....................................................... 30 An innovative target for the detection and treatment of Depression BRAINCO BIOPHARMA S.L....................................................... 32 Small molecules for the treatment of Schizophrenia CEIT..................................................................................... 34 Pyrogenic agents (endotoxins) detection both in fluids (biological reagents, pharmaceutical products) and in medical devices CEIT..................................................................................... 38 Software and Hardware for biomedical applications CEIT..................................................................................... 40 Systems Biology Fundación CIDETEC-IK4....................................................... 42 Biomaterials Synthesis and Electrochemistry DYNAKIN, S.L........................................................................ 46 Dynakin, strategic decision assistance for drug development via regulatory, Modeling & Simulation, Clinical Trial design and execution and GLP Biolab departments in four central European countries GAIKER-IK4........................................................................... 50 In Vitro Diagnostic tests GAIKER-IK4........................................................................... 52 Preclinical in vitro services GAIKER-IK4........................................................................... 56 Industrial biotechnology 4
  5. 5. HISTOCELL............................................................................ 60 GMP production of different cell therapy products HISTOCELL............................................................................ 62 Novel cell and tissue storage and shipping technology IKERLAT Polymers, S.L........................................................... 66 Organic and inorganic dispersions for diagnostic reagents and biological/ biotechnological fields INBIOMED............................................................................. 68 Derivation of human induced Pluripotent Stem Cells (iPSC-s) INBIOMED............................................................................. 70 GMP standards in viral vector production and flow cytometry IK4-TEKNIKER........................................................................ 72 Biosensors and micro/nanostructuring technologies INNOPROT............................................................................. 74 Cell-based Assay Development INNOPROT............................................................................. 76 Recombinant stable cell line for secretase activity assessment of potential drugs for Alzheimer’s disease INNOPROT............................................................................. 78 NomadTM Technology: The New Generation of Biosensors for HCS LABORATORIUM SANITATIS, S.L. TECNALIA .............................. 80 Pharmaceutical development, scale-up and manufacturing of medicinal products and investigational medicinal products for clinical trials LABORATORIUM SANITATIS, S.L. TECNALIA .............................. 84 Development and manufacturing of lipid nanoparticles as drug delivery systems METAL ESTALKI, S.L................................................................ 86 PVD ceramic coating for biotechnology and medical applications ONDAX Scientific S.L........................................................... 88 Clinical Trials in Animal Health OWL GENOMICS..................................................................... 90 Metabolomics and Lipidomics products an services provider PRAXIS BIOPHARMA RESEARCH INSTITUTE............................... 94 Pharmaceutical products development and production PRAXIS PHARMACEUTICAL....................................................... 96 Pharmaceutical products production and distribution PROGENIKA BIOPHARMA S.A................................................... 98 Functional genomics services PROTEOMIKA........................................................................100 Monitoring of biological therapies UPV.....................................................................................104 Preparation of magnetic biocatalysts and its uses in industry and biomedicine VACUNEK, S.L.......................................................................106 Developing novel vaccines for animal mycobacteriosis and nucleic acid amplification tests (NAATs) for animal diseases VICOMTECH..........................................................................108 Computer Graphics, Visual Computing and IT Solutions for the Processing, Analysis and Visualization of Biomedical Data and Knowledge Technology Offers: AGRI-FOOD..... 112 BIOFUNGITEK.......................................................................114 Fungicide and biostimulant products for control of main agricultural fungal disease CIC NANOGUNE....................................................................116 Spun food BIOLAN MICROBIOSENSORES S.L............................................118 Biosensors for the agro-food industry Technology Requests: HEALTH.... 120 GENETADI BIOTECH...............................................................122 Biosensor Instruments for In-Vitro Diagnostic Testing GENETADI BIOTECH...............................................................123 Development of new “in-vitro” and “in-vivo” methods to identify and isolate specific human DNA-regions previous to high-throughput DNA sequencing HISTOCELL...........................................................................124 New biomaterials for tissue engineering and cell therapy products INBIOMED............................................................................125 Bioreactors and large viral purification systems INBIOMED............................................................................126 Superesolution techniques/modules and long-term incubation modules for in vivo assays in confocal microscopy INNOPROT............................................................................127 Genetically-Encoded Fluorescent Biosensors PROTEOMIKA........................................................................128 Technological partners to develop new ELISA products for monitoring biologic therapies LABORATORIUM SANITATIS, S.L. TECNALIA..............................130 Pharmaceutical Products and Services Services.........................................132 ELUR...................................................................................134 Your Partner for Biotechnology facilities and Pharmaceutical Industry NESPLORA............................................................................136 Research and Development of Technology solutions for the Neuroscience: Diagnostic, Treatment, Basic Research and Prevention 5
  6. 6. Introduction 6
  7. 7. Basque Bioregion: BioBasque and the Basque BioCluster Strategic public-private collaborative frame- work for the development of life science in the Basque Country Over the last two decades, the Basque Government has undertaken scientific and technological policies which support the existing industrial fabric, but also prepare the Basque Country for future challenges by means of diversification into knowledge intensive sectors. The commitment to life sciences has been developed as a specific results-driven policy known as BioBasque Strategy. Strong government support with a pro- business orientation has helped the development of a thriving biosciences community, promoting the collaboration between the academic world, the health system and industry. Proven experience in clustering has also worked to create a nourishing environment that acts as a magnet for talent. Within this favourable framework, an attentive to technological revolutions private sector and an entrepreneurial spirit become assets for consolidating the Basque Biocluster. The role of the BioBasque Agency, hosted by the Basque regional development agency SPRI, during the last 10 years of implementation of BioBasque strategy has been to facilitate the emergence of the Basque bioregion, being its mission to align all horizontal public instruments for business promotion (R&D programmes, entrepreneurial support, venture capital, talent attraction programmes…) towards the specific aim of the creation of the Basque Biocluster. Since the creation of the Basque Biocluster in 2010, the close relationship between the two entities have paved the way for the consolidation of the small but vibrant Basque Bioregion with two main streams of activities: consolidation of the already existing biocompanies and promote the growth of the biocluster. Concrete ongoing examples are the development of a joint international commercialization platform for the biocompanies and the deployment of a sophisticated portfolio of services for bioincubation. The experience gained in the implementation of BioBasque strategy serves now as a basis for the design of the Basque Smart Specialisation Strategy. To find out more information, please visit: http://www.biobasque.org http://basquebiocluster.com Enterprise Europe Network Business Support on Your Doorstep The Enterprise Europe Network is a unique network made up of some 600 business support organisations in more than 50 countries throughout the European Union (EU) and beyond. It is dedicated to helping SMEs to make the most of the business opportunities in the EU. Launched in 2008 by the European Commission, the Enterprise Europe Network is the largest network in Europe providing expertise and services for businesses. The new Programme for the Competitiveness of Enterprises and Small and Medium-sized Enterprises (COSME), which will run from 2014 to 2020 and aims to encourage the growth and competitiveness of European firms, will ensure the continuity of the Enterprise Europe Network, building on previous results and lessons learnt. The mission of the BioChemtech Sector Group is to provide a niche service to one of Europe’s most important sectors: Biotechnology and Chemistry. This includes a comprehensive and high quality European knowledge transfer, information and business support service for organisations, particularly SMEs, with a view to increasing their competitiveness and promoting their overall economic growth. Basque Enterprise Europe Network consists of SPRI, Innobasque, Alava Chamber of Commerce, Bilbao Chamber of Commerce, Guipuzcoa Chamber of Commerce and BEAZ. To find out more information, please visit: http://een.ec.europa.eu http://www.eenbasque.net/ 7
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  9. 9. Technology Offers Health 9
  10. 10. Abstract of technology to exploit AJL OPHTHALMIC is the unique Spanish company dedicated to the design and manufacture of intraocular lenses and other ophthalmologic implants. Its premises are provided with all the required machinery and technology to produce and package ophthalmologic implants and other products involved in eye surgery. Moreover, AJL is part of many innovative projects with the aim of improving its technology and offering last generation products and services. Description AJL OPHTHALMIC, S.A. is a young and dynamic company which began its activity in the design, manufacture and distribution of medical devices within the field of ophthalmology in April 1998 and still continues working on the development of new intraocular lenses and other products of application in intraocular surgery. Our offer includes: • Design of new ophthalmological implants, manufacture, sterilization and commercialization of intraocular lenses and other medical devices as well as a wide variety of products and instruments used in surgery. • Availability of clean rooms ISO5 / ISO6 / ISO7 for product assembling and packing for third parties. • Possibility of sterilization in clean room and packaging in rigid blister. • Laser marking of surgical instruments or others for product customization. • Availability of classrooms for surgical training courses and Wet Labs for the diffusion of the last clinical procedures and researches in ophthalmology. Innovative Aspects We are involved in many innovative projects in order to achieve the latest available technology and thus, offer a high-tech production process and products. Our projects are directed to the following fields: Promoter organization identification Organization name AJL OPHTHALMIC SA (AJL) Contact Eva Larra Email evalarra@ajlsa.com Phone +34/945298256-289 Fax +34/945298209 Description of the organization Private Company Activity Manufacture and distribution of intraocular lenses and medical devices for ophthalmologic surgery Markets tackled Optical and health sectors Size SME Design, development and manufacture of intraocular lenses and other medical devices 10 Technology Offers · Health
  11. 11. • Microprocessing of optical quality surfaces. We have available optical inspection equipment. • New generation of materials and 3D Printing for advanced manufacturing. • Design of Biocompatible and Customized interfaces, surface and coatings for Intra Ocular Lens • Developments in tissue regeneration combining growth factors and mesenchymal cells. • New maxillofacial implant designs. Main Advantages The technology and products used in AJL OPHTHALMIC are directed to human health, being specialized in the ophthalmology field, therefore all the materials and processes we use are biocompatible with human tissues, and we also have the machinery to manufacture our implants and provide them sterility. In addition, we collaborate in many projects and work hard in new designs to keep growing as a company in order to cover the needs of the patients. Furthermore,ourfacilitiesareopentointeractionwithophthalmologists or other medicine specialists, offering training courses or displays of new surgical procedures and serving at the same time as a meeting point to understand better the arising demands. Applicability of the technology Our product offer includes: • Manufacture of ophthalmologic devices: · Intraocular Lenses (IOLs): PMMA, HEMA, foldable, injectable. · Other implants: Intracorneal rings and segments, orbital implants (Oculfit) or for retinal detachment treatment (Macular Buckling), among others. · Injectable solutions and stains: Viscoelastic, Silicon Oil or Typan Blue. · Glaucoma treatment: Esnoper, a non-reabsorbible scleral implant, designed to improve the drainage of aqueous hu- mour after undergoing Non-Penetrating Deep Sclerectomy. • Laser marking, packaging and sterilization of other surgical products and instruments. Current Stage of Development Currently we have many commercialised implants and other devices that are manufactured with validated equipment and processes. For further information you can visit on our website all the available products (www.ajlsa.com). Exploitation of RTD Results The products and technologies developed by AJL OPHTHALMIC SA are mostly the result of own funds, and have been also helped by projects supported by public entities. Intellectual Property Rights AJL holds two key patents on implants design: • Multifocal Ophthalmic Lens and its obtention process, Reference number 201031316. • Scleral Epimacular Implant, Reference number 12382348. All the products made in AJL have obtained the EC certificate, which assures the fulfilment of all the essential requirements established in the Directive 93/42/CEE on medical devices. Quality management system according to standards ISO 13485 and ISO 9001:2000. Collaboration Type Open to all type of collaboration with industry, research centres or universities. Technology Offers · Health 11
  12. 12. Abstract of technology to exploit We offer recombinant allergens for diagnosis and treatment of allergic diseases. Description Recombinant allergen allows a component resolved diagnosis of the allergic pathologies. Thus, patients who are allergic for instance to grass pollen, could know in detail –by cutaneous or in vitro tests– which is the responsible protein of their pathologies. Recombinant allergens can be easily coupled to membrane or plastic supports to allow quick individualized diagnosis. They can also adapt to microarrayed diagnostics devices. Innovative Aspects Most of commercial allergens used for diagnosis and all the ones used for allergic treatment (vaccines) consist of natural multiproteinic extracts. Recombinant allergens constitute an innovation, since the use of more defined, pure and reproducible substances can dramatically improve the clinical efficacy of the variability affected natural products. Main Advantages Recombinant allergens (RA) are much more reproducible than the natural extracts used so far for diagnosis and treatment (vaccines) of allergic diseases. RA are not affected by the variability of natural extracts from biological origin. Products for diagnosis and treatment based on RA can be prepared without the need of collecting the natural raw materials. RA can be more specific for diagnosis of allergy, since it can provide information of the precise protein molecules which elicit Promoter organization identification Organization name BIAL INDUSTRIAL FARMACÉUTICA S.A. (Bial-Arístegui) Contact Alberto Martínez Gárate Email alberto.martinez@bial.com Phone +34 944 438000 Fax +34 944 438016 Description of the organization Bial is a private pharmaceutical company which produces human medicines (allergenic vaccines and PMPs) Activity Manufacturing, commercialization and research of human medicines Markets tackled Pharmaceutical market Size Large industry Recombinant Allergens 12 Technology Offers · Health
  13. 13. the allergic reaction in every patient. RA can be more efficacious for the treatment of the allergic patients. Applicability of the technology More than a technology, what we are interested in offering is a product (RA) which can be used for manufacturers of diagnostics or vaccines in the field of allergic diseases. Current Stage of Development Currently we have many commercialised implants and other devices that are manufactured with validated equipment and processes. For further information you can visit on our website all the available products (www.ajlsa.com). Exploitation of RTD Results The products developed so far are a result of our own research, mainly with our own funs and partial supports from Basque and Spanish Government. Intellectual Property Rights Most of the RA developed have been patented by us, at national (more frequently) or international level. Some others have been left open to public domain. Collaboration Type Any kind of collaboration could be explored, from a simple sale to license sharing or co-development. Technology Offers · Health 13
  14. 14. Abstract of technology to exploit BBD BioPhenix has developed several toxicity and efficacy assays through the in vivo vertebrate zebrafish animal model. These assays analyze the toxicity and efficacy of compounds increasing the number of compounds tested faster and in a more cost-effective way. Toxicity assays already developed are acute toxicity, cardiotoxicity, teratogenicity, hepatotoxicity, neurotoxicity and otic toxicity. Efficacy assays are developed in oncology, neurodegenerative diseases and metabolism and inflammation areas mainly. These assays are carried out in early stages of the Drug Discovery process, prior to preclinical test in mammals, making a better selection of the best candidates. In addition, some of the assay has been automated through our High Content Screening (HCS) platform allowing a higher repeatability. Finally, Tailor-made solutions depending on specific requirements are developed having into account clients´ specific need. Description BBD BioPhenix is a Contract research Organization (CRO) that aims to help our customers worldwide developing tailor-made solutions to maximize their R+D productivity and minimize risks in the this process, integrating zebrafish animal model with innovative tools such as image analysis and automation. The company is located in GuipuzkoaTechnological Park, in San Sebastian, Spain, where among its modern installations has a zebrafish facility for housing up to 50,000 adult zebrafish, from different transgenic and/or mutant lines to allow several specific toxicity and efficacy assays. Target validation: though Morpholinos Disease models generations: in different therapeutic areas Toxicity and efficacy assays of compounds through zebrafish animal model Promoter organization identification Organization name BBD BioPhenix S.L.-Biobide Contact Arantza Muriana Email muriana@biobide.es Phone 0034-93 309360 Fax 0034-93 309370 Description of the organization CRO (Contract Research Organization) Activity Biotechnology Company offering preclinical services using zebrafish animal model for pharmaceutical, biotechnology, chemical, veterinary, cosmetic and natraceutical industries. This alternative model combines the advantages of in vitro and in vivo models, in the area of toxicity, safety and efficacy of drugs or agrochemicals, petrochemicals, functional foods or cosmetics. Markets tackled Pharmaceutical, Biotech, Agrochemical, Petrochemical, Functional Food and Cosmetic industries. Size 7 employees 14 Technology Offers · Health
  15. 15. by transgenesis (through TALENS technology) or mutagenesis. Toxicity assays: • Acute toxicity Assay. This assay based on a draft of an OECD guideline evaluates the presence of 3 different endpoints. • Cardiotoxicity Assay: This fully automated assay through our HTS platform evaluates QT prolongation, presence of arrhythmia, bradycardia as well as cardiac arrest. • Teratogenicity/developmental toxicity Assay: In a week period 40 different endpoints are identified and measured. • Hepatotoxicity Assays: Different assays have been developed in this area as it constitutes the second cause of drug withdrawal. • Neurotoxicity Assays: Behavior alteration tracking in zebrafish by the Noldus automated system. • Otic toxicity Assay: Otic toxicity can be analyzed by counting the number of neuromasts (mechanosensory organs in zebrafish). • Tailor-made solutions: Different toxicity assays can be adapt or developed depending on customer requirements. Efficacy assays: • Oncology: · Angiogenesis Inhibition Assay. · Screening in tumoral models: melanoma, hepatocarcinoma,… • CNS: · Antiepileptogenic Assay. · Screening on neurodegenerative disease models: Parkinson´s Disease (PTZ…), Alzheimer´s diseases … • Metabolism: · Lipids metabolism, obesity, diabetes…. Innovative Aspects BBD BioPhenix is structured around the zebrafish vertebrate animal model that allows combining in vitro and in vivo advantages to work under the 3 R´s, decreasing number of animals used. Its aim is to reduce the time and the cost required for the Drug development process, increasing the compound success rate and decreasing the failures ratio due to adverse side effects, throughout the drug research and development process. The objective is to detect the compounds that due to their toxicity would be discarded at the end of the Drug Discovery process, but in very early stages of it. Zebrafish embryos are ideal to integrate toxicity and efficacy assays, ensuring a high number of compounds tested in a short period of time, and with a lower cost. In the other hand, automation increases repeatability. Main Advantages BBD BioPhenix will allow companies to focus their R&D efforts and Technology Offers · Health 15
  16. 16. investments in their new compounds with the highest success rates among the Drug Discovery process, due to their proven efficacy, for a better selection of successful candidates. Applicability of the technology For Pharmaceutical and Biotechnology Companies, Chemical Companies (Petrochemical or Agrochemical), Functional Food Companies, Cosmetic in early stages of Drug Discovery process, prior to preclinical test on mammals, for mass screening of potential drugs or lead optimization, or even re-profiling of compounds. Applicability: toxicity assays for potential new drugs, petrochemical compounds, pesticides and fungicides, natraceuticals and cosmetics; as well as efficacy assays for potential new drugs. Current Stage of Development Those assays are validated manually and / or automated for reference products, and are developed under GLP standards and using the most innovative technologies. Exploitation of RTD Results All the different assays are product of our own know-how and development. Collaboration Type • Outsourcing of already developed assays • Tailor made solutions · Customization of established assays · Further development of ongoing projects · Development of new applications 16 Technology Offers · Health
  17. 17. Technology Offers · Health 17
  18. 18. Abstract of technology to exploit FASTBASE offers an advanced diagnostic technology in the field of oncology both for pharmaceutical and academic purposes. This technology permits to quantify, protein activation states and protein-protein interactions. The technology has already been tested and validated in human tumour biopsies to detect biomarkers with the aim to help diagnosis and treatment prescription of patients, but can be also applied to many other diseases, as cardio-vascular and neurodegenerative diseases. The technology is based on a novel methodology, known as amplified-time resolved-Förster Resonance Energy Transfer (FRET), utilised for assessing oncoprotein activation and protein-protein interactions in a highly specific, spatially resolved, sensitive manner and using a portable high throughput system. This technology will become critical in patient evaluation both diagnostically and predictively. We have already exploited this technology to demonstrate that the activation of an oncoprotein in breast and colon cancer patients is heterogeneous and correlates with poor disease free survival. Description Tissue based diagnostics remains cornerstone of personalised medicine. However, most of the current methods of analysing protein expression via immunohistochemistry lack adequate quantitation, sensitivity, selectivity and accuracy. Specifically, the detection of endogenous oncoproteins in fixed tumour samples faces several important challenges: • The specific detection of post-translational modifications such as phosphorylation. • The simultaneous localisation of these oncoprotein epitopes in preserved tissue architecture iii) the quantitative capture of data in an automated manner. Promoter organization identification Organization name BIOFISIKA (Basque Center for Biophysics) Contact Prof. Banafshé LARIJANI Email Banafshe.larijani@ikerbasque.org Phone 0034 946018505 Fax - Description of the organization Public Institution Activity R&D services and technology Markets tackled Oncology, Diagnostic devices, Biotechnology, Biomedicine and Pharmacology Size 110 FRET Amplified Signal Technology for Biomarker And System Evaluation- (FASTBASE) 18 Technology Offers · Health
  19. 19. Immunohistochemistry (IHC) is the most readily available method to assess activation of intracellular proteins, however it is limited by the absence of precise quantification and the lack of a standardised scoring system. In addition, it is a “one-site” assay (including fluorophore-based confocal assays) producing results that can only be obtained from measuring the intensity of one label at a time, therefore limiting specificity where epitopes are constrained (eg phosphorylation sites). To solve the above issues we have used time-resolved FRET for sensitive analysis. FRET detected by fluorescence lifetime imaging microscopy (FLIM) has been proven to be a highly effective method in quantifying the phosphorylation status of intracellular molecules in archived formalin-fixed paraffin- embedded (FFPE) tumour tissue. Coincidence (two-site) FRET describes the method of simultaneously labelling a single protein on two distinct sites with donor- and acceptorconjugated probes, and detecting the FRET between them. When using twosite FRET, notwithstanding that this method also relies on antigen-antibody immune complexes, energy transfer only occurs when the distance between the two antibodies (for example directed at a specific phospho-site and the protein itself) is less than 10 nm, within the same antigen. Two-site FRET is therefore necessarily more specific. To date studies of endogenous proteins using FLIM have been limited due to the lack of sensitivity and the additional requirements for extensive characterisation of directly labelled antibodies for each assay developed. Our method solves these problems by amplifying the signal and doing so in the context of using generic secondary reagents. This assay combines immunofluorescence signal amplification with labelled Fab fragment secondary antibodies in order to maximise sensitivity, specificity. In parallel, we have developed an imaging platform based on a multiple frequency fluorescence lifetime imaging microscope (mfFLIM) and accompanying software to automatically map a tissue microarray, acquire FLIM images and distinguish between regions of interest in single cells and tumours, in a high throughput manner with minimal user supervision. Innovative Aspects 1-This technology detects molecules in a single cell or tissue samples, in particular, protein functional states and protein complexes . 2- This technology permits the quantification of molecular interactions, such as protein-protein interactions in a single cell or tissue sample. Whereas existing technologies can detect co- expression, it cannot quantify dimerisation. 3-Use of FRET (and specially two-site amplified-FRET methods, where the two sites are on the same protein or on different proteins) in combination with an enzyme activation amplification system improves detection of states of molecules in a single cell or tissue samples, such as protein states and a close spatial association of proteins. Main Advantages The main advantage of this methodology over the current technologies, immunohistochemistry and proximity ligase assays (PLA) are as follows: Highly specific for in situ detection of post-translational modifications such as phosphorylation as well as endogenous protein-protein interaction Amplified time resolved FRET which is highly specific and sensitive with the advantage of it being readily adapted to any protein marker A broad dynamic range, enabling high accuracy and precision Simultaneous localisation of proteins in preserved tissue architecture Technology Offers · Health 19
  20. 20. Acquisition and processing of a large quantity of data in an unbiased automated, high throughput manner Table summarising the main advantages of amplified-FRET over current technologies Immuno- histochemistry PLA Amplified- FRET Sensitivity + ++ ++++ Selectivity + +++ +++ Dynamic Range + ++ ++++ Protein-Protein interaction - ++ ++++ Modified Proteins + +++ ++++ Applicability of the technology To date this methodology has been mainly exploited in solving problems that have been related to early diagnostics in Cancer . However, since the main aspect of this methodology is to quantitatively determine endogenous protein-protein interactions (complex formations) and detect activation status of marker proteins then it can also be used in answering questions in pathological states such as diabetes, cardio-vascular disease, diseases related to aging and neurodegenerative pathologies. Therefore the methodology is not exclusive to answering questions regarding cancer. Current Stage of Development The current methodology is in a prototype stage that will lead to commercialisation. It is complete in its actual stage however it now needs to be tested in “prospective trials”. The retrospective studies performed by this methodology have shown its advantages over classical immunohistochemistry studies. The next step to conclude is the validation of the technology in order to perform prospective trials in the Spain, UK and USA. Exploitation of RTD Results To date the development of the methodology has been wholly funded by Cancer Research UK, a registered charity in UK. Intellectual Property Rights In 2013, Cancer Research Technology (UK) filed the patent P26770GB- “Oncoprotein activation in tumours assessed by high throughput coincidence signal amplification-FRET”. As of the 11th March 2014 Cancer Research Technology has filed a PCT – PCT/GB14/050715. The expected publication of the Patent will be 11th September 2014. Cancer Research Technology is keen on partnering this technology with us. Collaboration Type Our goal is to be the first European company that analyses cancer patient samples using this innovative technology. Our main focus will be to offer a diagnostic service through the analysis of biopsies from oncology units at hospitals, as well partnering with pharmaceutical companies in clinical trials analysing tumour samples of patients involved in the trials. Moreover we our focus would be to partner with pharmaceutical companies to utilise the novel methodologies as a tool to help development of companion diagnostics. Collaborations/service offerings to Research Institutions will also be considered depending on the project proposal. 20 Technology Offers · Health
  21. 21. Technology Offers · Health 21
  22. 22. Abstract of technology to exploit The Biofisika Open Innovation Platform (Biofisika-OIP), an initiative of Biofisika ( the Basque Center for Biophysics), aims to give customized R&D support to Small and Medium Enterprises (SMEs) as well as to Industrial Partners looking to provide and/or strengthen the innovation of their products and services. The Biofisika-OIP can act as an R&D service provider or as your R&D partner in innovation projects requiring strong scientific and technological input. Being focused in all aspects of molecular, cellular and systems biophysics, the Biofisika-OIP can offer a unique expertise to the industry, including Pharmacological, Cosmeceutical, Nutraceutical, and bioenergetic, as well as to Public Institutions. The Biofisika- OIP mission is to assist partners and customers in innovation projects by providing the necessary R&D, in a very tailored and client-wise vision. Description The Biofisika-OIP is structured in 4 technological platforms that provide all the infrastructure needed for carrying the most ambitious R&D projects: 1. Molecular and Cellular Imaging Platform: An Advanced Optic Microscopy Unit, offering a singular nanofotonic technology for image analysis that allow the study of quantitative spacetemporal inter- and intramolecular interactions in cells. These studies can be conducted at the advanced Optic Microscopy Unit through confocal microscopy and two photon systems, and through the study of the spectroscopic properties of the fluorescent emission at a single pixel (FRET-FLIM y FCS). Promoter organization identification Organization name BIOFISIKA (Basque Center for Biophysics) Contact Dr. Roberto Pascual Email roberto_pascual001@ehu.es Phone 94-6018001 Fax - Description of the organization Public Institution Activity R&D services and technology Markets tackled Biotechnology, Biomedicine, pharmacology and skin care. Size 110 Biofisika Open Innovation Platform (Biofisika-OIP) 22 Technology Offers · Health
  23. 23. 2. Drug Discovery and Delivery Platform: A High Throughput Screening (HTS) Unit to design robust and accurate in vitro screening assays for Drug Discovery and Drug Repurposing projects. The platform posses the equipment to both test single compounds and screen chemical libraries for hit identification and lead validation, as well as for in silico screening. The Drug Discovery and Delivery Platform offer also an Electrophysiology Unit and a Quimeric Vaccines Production Unit. The Drug Delivery Unit exploits both the equipments and the know-how of Biofisika Scientists to design and test new and effective Drug Delivery Systems. 3. Protein Expression and Structure Platform: This platform offers up to seven Equipment Units to produce proteins (up to mg) both in prokaryotic and eukaryotic systems, for solving the protein structure, and characterize their folding and biophysical properties, as well as for protein engineering. The Protein Expression and Structure Platform include the following Units: • Centrifugation and simple concentration Unit • Microcalorimetric Analysis Unit • Chromatography Unit • Image Acquisition, Treatment and Documentation Unit • Spectroscopy Unit - Crystallography Unit 4. System Biophysics Platform: This platform offers a customized protein and systems modeling service through its potent Bioinformatics Unit. This service is mainly oriented to biophysical studies and drug-discovery, but Biofisika-OIP is open to assist in tailored bioinformatic needs and requierements. Innovative Aspects The Biofisika-OIP combines a multidisciplinary team of top qualified scientists and technicians arranged in two main Research Lines, offering a wide range of tailored programs and solutions for innovative biotechnological and biomedical projects: Molecular Biophysics, which encompasses the following areas: Protein Structure and Folding, Membrane Structure and Dynamics, Membrane Transport and Bioenergetics, Molecular Chaperons, Membrane Toxins. Cellular and Systems Biophysics, which encompasses these areas: Membrane and Cell Fusion, Cellular Excitability and neural Networks, Cellular Imaging and Dynamics, Nanomechanics and Single Molecule, Systems Biology and Medicine. Main Advantages The Biofisika-OIP offers an innovative scientific and technological strategythatmakesthisplatformauniqueR&Dproviderofinnovative knowledge to boost the development and implementation of competitive projects that will result in strengthening the innovation capabilities of industrial and academic partners. The Biofisika- OIP offers a singular and up to date scientific infrastructure that is pivotal to successfully achieve innovative, R&D projects that require quantitative assessment. The cost of the equipments, Technology Offers · Health 23
  24. 24. maintenance and the need of highly trained personnel is a handicap for in-house setting by SMEs and industrial and public partners. Thus, outsourcing innovation projects and partnering with the Biofisika-OIP is the more convenient, wise strategy to create and develop innovation, competitiveness and internationalization to your products and projects. Furthermore, access to the know-how generated by Biofisika scientific groups is an additional advantage for outsourcing your innovation projects to the Biofisika-OIP. The time needed to acquire the know-how and experience in each area is another invaluable asset of Biofisika, which can be accessed through the Biofisika-OIP, to gain a competitive knowledge and advantage for SMEs in their innovative projects. The Biofisika-OIP technological offer covers a wide range of biophysical techniques, equipments and in house developed assays. All Biofisika Technological Platforms offered are complementary, accordingly the wide range of the R&D activities needed for the successful development of innovation initiatives is guaranteed. Biofisika, through its Biofisika-OIP, is your natural partner for creating innovation and increasing national and international competitiveness for your products and services. Applicability of the technology The Biofisika-OIP offers the design and development of customer- driven R&D projects, R&D consultancy, and supervision of in- house ongoing R&D initiatives. The Biofisika-OIP gives solutions to your needs by adjusting its R&D capabilities to provide innovative solutions to your requirements. The Biofisika, throuogh its Biofisika-OIP, can be a valued partner for: • Biotech Companies • Pharmaceutical Companies • Nutraceutical Companies • Cosmeceutical Companies • Functional Food Companies • Energy-based companies • Diagnostic-based companies • R&D Groups (from research centers, Universities…) • Foundations • Clinical departments and hospitals The Biofisika-OIP will study your proposal and elaborate a tailor- made project to adapt to your needs. The Biofisika-OIP will accommodate the project to your requirements and provide you with your needed innovation. Partnering with BiofisikaOIP makes a lot of R&D sense to be ahead of your competitors. Current Stage of Development Biofisika, the Basque Center for Biophysics, first known as the Biophysics Unit, is a joint venture between the UPV/EHU, the CSIC and the Fundación Biofisika Bizkaia (FBB) that was created 12 years ago in the UPV/EHU campus in Leioa. In 2014, Biofisika will move into new state-of-the-art research facilities in the UPV/EHU Scientific Park in Leioa Campus, where the Biofisika- OIP will be fully active. In addition, in 2014 Biofisika has elaborated a Strategic Plan for 2014-2017 where translational biophysics is a major goal and priority. Accordingly, the activities of the Biofisika-OIP will be strengthened, and complemented with the incorporating new research groups that will provide 24 Technology Offers · Health
  25. 25. complementary skills and knowledge in the fields of molecular and systems neurosciences, and molecular and cellular oncology. Furthermore, scientific infrastructures and human resources will be upgraded as needed, by incorporating the needed skills to offer the best and most efficient R&D services and partnership, and to strengthen the research excellence. Exploitation of RTD Results In addition to provide R&D services to external partners, the Biofisika-OIP also represents the natural channel for the exploitation of in-house generated knowledge and technology, by pursuing agreements with third parties interested in licensing the technology or by encouraging and assisting in the creation of spin-off companies. Intellectual Property Rights Intellectual Property Rights will vary depending on the kind of project and the relationship established between the customer and the Biofisika-OIP. These agreements are always negotiated in a flexible way to ensure the transfer and exploitation of the technologies. In this regard, Biofisika always pursue to be involved in the development process to ensure that the technology reaches the market. Collaboration Type Outsorcing Joint-development of R&D projects and initiatives Technology Offers · Health 25
  26. 26. Abstract of technology to exploit Bioftalmik has developed a tear based “ Point of Care” lab-on- a-chip for specific, sensitive, and non-invasive diagnosis for Dry Eye and Ocular Inflammation. Our expertise on the study of proteins, metabolites and genes for biomarkers discovery in samples as tears and ocular surface cells together with clinical tests, has implied the development of new tools for diagnostic in the ophthalmology field. In our molecular diagnostic division, Bioftalmik has developed a PCR-based diagnosis for Limbal Deficiency. This test is highly sensitive and specific, and provides a decision-making tool for surgery and medical treatments such as corneal transplant, limbo transplant, etc. In the ophthalmic devices development unit, Bioftalmik has developed the “first and unique” one handed disposable intraocular injector designed for ophthalmologists for easier, faster and safer procedure than performed with standard syringes. Description Ocular diseases are main cause of blindness worldwide, loss vision or impairment of visual function, therefore early disease detection is a key factor for control of loss vision and correct medical treatment. The development of kits and tests for diagnosis, prognosis, and therapy based on molecular markers for ocular diseases such as dry eye, blefaritis, other inflammatory ocular diseases, and glaucoma is the core of our research. The study of non invasive samples such as human tear and cornea/conjunctival cells leads the identification of proteins, metabolites and genes. As one of the body fluid, the tear is a complex secretion containing proteins, mucins, lipids, carbohydrates, hormones, neurotransmitters, electrolytes, etc. The human tear proteome, for example, provides a unique source of specific protein markers of protein patterns that Promoter organization identification Organization name Bioftalmik Applied Research Contact Jon Careaga Email jon.careaga@bioftalmik.com Phone +34 944 069 659 Fax +34 946 562 379 Description of the organization Biotechnology Company specialized in the ophthalmic field Activity Our main objective is to design, develop and commercialize diagnostic, prognostic and therapeutic systems for eye diseases and biodevices for ophthalmic surgery. Markets tackled Ophthalmology, public and private hospitals, pharmaceutical companies. Size 7 employees Tear based diagnostic test for ocular diseases 26 Technology Offers · Health
  27. 27. may be correlated to more effective diagnosis, prognosis, and response to therapy. With the traditional methods about 100 tear protein have been obtained, however, using proteomics approach it have been possible to find more than 400 proteins. Proteomic techniques have been developed to trigger the progression of the tear studies either in the protein composition and/or concentration of tear and various pathological conditions. The comparable study of healthy and/or disease subjects have lead the discovery of new biomarkers. Additionally, metabolomic studies are carried out for new markers searching. Similarly, the study of genes and proteins from ocular surface cells using non invasive or minimally invasive samples (ex. Impression cytology) provides relevant tools for molecular PCR- based diagnosis of ocular diseases, and the evaluation of cells response to medicines or treatments. In this way, it is possible to establish the response to and effects on ocular surface cells due topical drugs such as antiglaucomatous, and other therapies. Disposable devices for ocular surgery, and systems for drug delivery specifically inside of the eye are important systems in treatment of several diseases such as AMD or glaucoma. We offer a new system that allows doctors the intraocular injection using only one hand providing a total control of the eye and facilitating a safer and faster procedure than offered by currently used systems. Innovative Aspects The most of ocular diseases are diagnosed on the symptoms referred by the patient, clinical observation by physician, and tests performed by specialised equipment. However, early states of diseases are not easy to detect given that many symptoms are similar in several diseases, thus, the detection of an ocular pathology normally is done when the symptoms are evident, and the damages in cells and vision alteration have happened. Changes in tear proteins have been associated with many ocular or systemic diseases, therefore, the platform for early diagnosis based on tears analysis constitute an innovative solution for clinical diagnosis. Similarly, cells of ocular surface respond differently to environment changes and/or application of medicines and treatments. Normally this kind of response is studied in human by traditional PAS staining of epithelial cells that indicate the state of cells, as an innovative approach, we analyse the protein and gene expression of those cells impregnate on the membrane through the impression cytology of corneal/conjunctival epithelial cells. Main Advantages • Rapid diagnosis in non invasive samples. Using samples such as tears and conea/conjuctiva epithelial cells we detect specific biomarkers for several ocular diseases. • Analysis and detection in very small samples. Normally the small volume of tears limits its use as source of markers; we have established a platform work that enables diagnosis based on markers expressed in very small volume. Similarly, the impression cytology provides a source of cells which rends a small amount of protein and/or genetic material in which we are able to determine biomarkers for diagnostic. • Diagnosis of systemic diseases. The tear is considered a source of markers for ocular diseases but also for systemic diseases such as diabetes, cancer, etc. therefore, our diagnosis platform can be employed on other fields of health. • Personalised therapy. Given that we have specific markers for several diseases, we are working on the development of personalised therapy alternatives based on those markers. • Customized devices for easier ophthalmic procedures, such us ocular injection. Technology Offers · Health 27
  28. 28. Applicability of the technology • Ophthalmology field, in both clinical practice and basical and applied research. • Pharmaceutical companies focused on development of medicines for ocular diseases, • Companies that produces contact lens, IOL, topical drugs, eye drops, etc. • Pharmaceutical companies in general. • Clinics and hospitals to solve the problems of accurate diagnostic. Current Stage of Development Currently we have some products/services already developed in a commercial stage for diagnostic uses, mainly in public hospitals and clinical. Others are on preclinical and clinical validation and others also in the development of prototype. Some others products are still at a level of research, development and design. Exploitation of RTD Results The most of the products developed are results of our research funded with our funs and also partial supports from Basque and Spanish Government. Intellectual Property Rights We have patented or are in process of patent for all the products and services offered by the company. Collaboration Type We offer contract research development for “Point of Care” non invasive diagnostic and monitoring devices development based in tear film biomarkers from discovery phase to final product development. 28 Technology Offers · Health
  29. 29. Technology Offers · Health 29
  30. 30. Abstract of technology to exploit New target was discovered through the study of pathological brain tissue of patients with major depression. The project aimed to find active molecules that regulate the biological system in which this new target is involved: neurogenesis. BRAINco validated its hypothesis with the generation of a transgenic animal model that can be considered as a non- clasical model of depression. This transgenic model has also allowed the identification of promising cell signaling pathways affected by the overexpression of the identified target. The fact that the selected target was a secreted cytokine, has opened the possibility of using it as a biomarker for depression diagnosis and/or patient selection. Description Major depression is a common and sometimes fatal disorder that has lifetime prevalence in excess of 15%. The total annual cost of Depression in Europe is estimated at 118 billion €, which makes depression the costliest brain disorder in Europe. Current antidepressant treatments are limited by their efficacy and in particular, by the delay in their onset of action. Their activities depend on common mechanisms of action such as selective neurotransmitter reuptake inhibitors or monoamine oxidase inhibitors. New therapies based on novel mechanisms of action are needed to solve these problems. Using genomic and proteomic approaches in human postmortem brain tissues from depressive suicides, BRAINco found altered expression levels of a key cytokine involved in neurogenesis. The implication of neurogenesis in major depression is widely accepted among the scientific community. In fact, antidepressant drugs produce an increase of neurogenesis in accepted animal models of depression. BRAINco scientists have confirmed the implication of the target on the modulation of neuronal proliferation and differentiation. Promoter organization identification Organization name BRAINco Biopharma S.L. Contact Itsaso Hormaeche, R&D Manager Email ihormaeche@brainco.es Phone +34 944 064525 Fax +34 944 064526 Description of the organization Privately Held Activity CNS Drug Discovery CNS in vitro diagnosis Markets tackled Drug discovery Size 5 employees An innovative target for the detection and treatment of Depression 30 Technology Offers · Health
  31. 31. The in vivo validation of the role played by the selected target in the etiopathology of Depression has been performed by the generation of a transgenic animal, model that has also allowed the identification of a number of cell signaling pathways and proteins affected by the initial target. Several of these secondary identified targets have already been used by other pharma companies in drug discovery programs for other clinical indications (Lead compounds are commercially available). On the other hand, the identified target is a secreted cytokine with the potential of becoming a biomarker for the diagnosis and/ or patient selection and stratification. Innovative Aspects • A novel mechanism of action found altered in the human disease. • The Target has been validated by the generation of a transgenic animal model. • The identification of signal transduction pathways altered in the transgenic animal model (and already used for other clinical indications) that could represent innovative targets for the treatment of Major Depression. • The target is a secreted cytokine that can be measured in the blood. Main Advantages BRAINco Project Operational Focus: • Specific structures for specific projects. • Screening cascade elements is developed together with the ones who will use it. • Provides operational flexibility. • Defines development responsibilities, schedules, milestones, and deliverables. • Focuses on how the relationship will work (e.g., communication, issue resolution, project reviews). Applicability of the technology Although today’s treatments for psychiatric disorders are generally safe and effective, they are far from ideal. In addition to the need of administering the drugs for weeks or months before seeing any clinical benefit, side effects are still a serious problem even with the newer medications. And most importantly, about only a third of these patients with these psychiatric diseases, show fully remission with optimized treatment. Consequently, new therapies based on innovative approaches that represent a real qualitative change in pharmacological strategies are urgently needed. Current Stage of Development This program is based on new biological targets and pathways not explored for this disease. The program is under development/lab tested. A patent has been applied for but not yet granted. Collaboration Type BRAINco would consider different models of partnership from purely financial, to a combination of financial and development collaborations. We are particularly interested in companies with expertise in CNS diseases, in particular, to medicinal chemistry and preclinical studies. We are also interested in maintaining open communication line with companies with interest in our project. Technology Offers · Health 31
  32. 32. Abstract of technology to exploit New target was discovered through study of pathological tissues of schizophrenic patients. The project aimed to find active molecules that regulate the biological system in which this new target is involved: the release of neurotransmitters. BRAINco has discovered and validated a novel target, both at the animal and cellular level, has created the tools necessary for drug discovery and development, and has identified chemical starting points. Description Since 1990s with the emergence of atypical antipsychotics, there have been no major advances in the treatment for schizophrenia. While current drugs modify synaptic transmission acting on dopaminergic system, BRAINco is focusing on the actual process of neurotransmitter release. BRAINco discovered that proteins involved in exocytosis are differently expressed in the prefrontal cortex of schizophrenic subjects. Cellular and Biochemical tools as well as an animal model were produced to validate this novel model targeting exocytosis. BRAINco is also performing a biomarker program in parallel of the drug discovery, in order to develop a strategy for patient selection. The product will be a tool kit composed of all materials developed for the project, such as stable neuronal cell lines, cellular based assays, assays adapted for High Throughput, Hits, back up, and active molecules that regulate the release of neurotransmitters throughout the modulation of the Exocytosis. Promoter organization identification Organization name BRAINco Biopharma S.L. Contact Itsaso Hormaeche, R&D Manager Email ihormaeche@brainco.es Phone +34 944 064525 Fax +34 944 064526 Description of the organization Privately Held Activity CNS Drug Discovery CNS in vitro diagnosis Markets tackled Drug discovery Size 5 employees Small molecules for the treatment of Schizophrenia 32 Technology Offers · Health
  33. 33. Innovative Aspects • A novel mechanism of action found altered in the human disease. • A very innovative target validated in cellular and animal models. • Hits able to modulate presynaptic activities. • Experience in Biomarker discovery. Main Advantages BRAINco Project Operational Focus: • Specific structures for specific projects. • Screening cascade elements is developed together with the ones who will use it. • Provides operational flexibility. • Defines development responsibilities, schedules, milestones, and deliverables. • Focuses on how the relationship will work (e.g., communication, issue resolution, project reviews). Applicability of the technology Although today’s treatments for psychiatric disorders are generally safe and effective, they are far from ideal. In addition to the need of administering the drugs for weeks or months before seeing any clinical benefit, side effects are still a serious problem even with the newer medications. And most importantly, about only a third of these patients with these psychiatric diseases, show fully remission with optimized treatment. Consequently, new therapies based on innovative approaches that represent a real qualitative change in pharmacological strategies are urgently needed. Current Stage of Development This program is based on new biological targets and pathways not explored for this disease. The program is under development/lab tested. A patent has been applied for but not yet granted. Collaboration Type BRAINco would consider different models of partnership from purely financial, to a combination of financial and development collaborations. We are particularly interested in companies with expertise in CNS diseases, in particular, to medicinal chemistry and preclinical studies. We are also interested in maintaining open communication line with companies with interest in our project. Technology Offers · Health 33
  34. 34. Abstract of technology to exploit We offer a simple, economic and highly sensitive system for pyrogenic agents (endotoxins) detection both in fluids (biological reagents, pharmaceutical products) and in medical devices Description National and international health authorities require that any implantable medical device or parenteral drug undergoes strict analyses to verify that it is free from pyrogenic agents. Pyrogens are molecules of microbial origin which at very low concentrations (femtograms) are detected by the immune system and induce beneficial responses including moderate fever and local inflammation. However, at higher concentrations (micrograms) these molecules trigger acute systemic reactions such as septic shock that often lead to multiorganic failure and death. Due to its toxicity, stability and prevalence, the most important pyrogen is the lypopolysaccharide (LPS or endotoxin), a molecule present in the surface of gram-negative bacteria. The standard method for LPS detection is the, so called, Limulus Amoebocyte Lysate test or LAL test, which is based on the coagulation cascade of the amebocytes of the horseshoe crab (Limulus polyphemus). This test is laborious, expensive and yields false negative results in the presence of certain organic and inorganic compounds. Furthermore, the low sample volume required for the test limits its sensitivity. We offer a totally new and innovative method for detecting these pyrogenic agents much more robust than the protocols based on LAL test. Promoter organization identification Organization name CEIT-IK4 Contact Gustavo Pego Email gpego@ceit.es Phone +34 660 080 652 Fax +34 943 213 076 Description of the organization CEIT-IK4 is a non-profit research centre. The Centre’s main aim is to carry out applied industrial research projects through close collaboration with Industrial R&D departments on a contractual basis. Activity Industrial applied research Markets tackled - Size - Pyrogenic agents (endotoxins) detection both in fluids (biological reagents, pharmaceutical products) and in medical devices 34 Technology Offers · Health
  35. 35. Innovative Aspects Currently, the standard endotoxin detection method is the Limulus Amebocyte Lysate (LAL) test, which is based in the lymph gelification system of the marine chelicerate arthropod known as horseshoe crab (Limulus polyphemus). This system works as a coagulation cascade triggered by endotoxin interaction with the serine-proteases present in the amebocytes of the animal. There are three main LAL test methodologies commercially available: gel-clot, turbidimetric, and chromogenic. LAL-based tests have the following limitations: - High price: the cost of these tests ranges between 6 and 60 €/sample depending on the detection method used and the number of samples per assay. These estimations do not take into consideration the cost of the special equipment (chromogenic and turbidimetric methods) and software (turbidimetric) needed to perform the tests. In addition, the cheapest kits (for multiple samples) do not include the pyrogen-free material needed to repeatedly carry out the assays (tubes, microplates plasticware, etc). - Irregularity: kits usually have significant batch-to-batch variability. - Instability: The shelf-life of the reagents is very short. For instance, under optimal storage conditions, some of the LAL reagents are not suitable for use one week after reconstitution. - Lenghty assay times: tests do not yield immediate results but are laborious and require several incubation steps, which prolongs the assay time to at least one hour for the most rapid (and expensive) assays. - Unreliability: assays are unreliable in the presence of interfering substances and yield either false positive or negative results. Inhibiting agents include chelators, alcohols, penicillins, tripsin inhibitors, and NaCl above certain concentration, whereas unspecific activators of the LAL cascade comprise compounds such as thrombin, thromboplastin, nucleic acids, Rnases, tripsin, lipoteichoic acids, glucans and peptidoglican, among others. These interferences preclude the use of LAL tests for endotoxin quantification in blood. In addition, results of LAL assays are strongly affected by pH and are only trustworthy when performed at pHs ranging from 6 to 8. Our device improves most of the characteristics of the standard endotoxin testing assay, the LAL test, therefore the intended device would have to match the sensitivity of this test and simultaneously overcome the limitations describe in the previous paragraphs. Main Advantages This technology addresses a simple, economic and highly sensitive new system for endotoxin detection both in fluids (biological reagents, pharmaceutical products) and in medical devices. For this purpose, this project will undertake the following tasks: 1. A robust and specific immobilization procedure for endotoxin detection based on patented and specifically designed peptides. 2. A portable device as an enhanced alternative to the LAL method. Technology Offers · Health 35
  36. 36. Applicability of the technology As previously described we offer a competitive solution, highly sensitive and reliable, for endotoxin detection in biological reagents, products related to pharmaceutical industry and medical devices. There are several industrial partners that would greatly benefit from the proposed system. Both parenteral drugs and invasive medical devices are required to undergo pyrogen testing to certify that they are virtually free from endotoxin. Thus, the more accurate and affordable the detection system, the safer the products marketed by the pharmaceutical and biomedical manufacturers. Current Stage of Development The proposed device is already tested in laboratory conditions with synthetic and real samples obtained from some companies that collaborate with us. Now the device is ready for the validation procedure by regulatory agencies. Exploitation of RTD Results The research project was funded by own resources of the University of Navarra. Intellectual Property Rights All the IPR belongs to the groups that are developing the device. Collaboration Type We are looking for industrial partners that could be interested in this device to complete together the validation procedure. 36 Technology Offers · Health
  37. 37. Technology Offers · Health 37
  38. 38. Abstract of technology to exploit CEIT-IK4 develops software for biomedical applications. Besides, CEIT-IK4 has capabilities of mechatronic design for designing and manufacturing its own hardware (electronics and mechanics). Description The main research lines are: • Medical imaging processing from any kind of source (CT, MRI, DTI MRI, fMRI, etc.). • Based on our knowledge of medical imaging processing and computer graphics, we can develop complex applications of diagnosis, analysis and surgery planning. •Modelling and simulation of different tissues with different applications: · Analysis of tissues behaviour · Development of surgery simulators with the possibility of using haptic devices • Biomechanics of human motion (impact studies, musculoskeletal human modelling, human motion reconstruction and analysis) • Control and programming of robots • Mechanical and electronic design for new medical devices Promoter organization identification Organization name CEIT-IK4 Contact Gustavo Pego Email gpego@ceit.es Phone +34 660 080 652 Fax +34 943 213 076 Description of the organization CEIT-IK4 is a non-profit research centre. The Centre’s main aim is to carry out applied industrial research projects through close collaboration with Industrial R&D departments on a contractual basis. Activity Industrial applied research Markets tackled - Size - Software and Hardware for biomedical applications 38 Technology Offers · Health
  39. 39. Innovative Aspects In Applied Mechanics department we are able to mix software and hardware knowledge in order to offer more complex products. The combination of multiples disciplines provide us not only with a whole knowledge of the problem but also with the capacity of offering the whole solution. Main Advantages Thanks to our deep knowledge of software and hardware we can develop complex turnkey solutions for our clients. Applicability of the technology As we develop turnkey software and hardware, our technology is broadly applicable in any biomedical sector. Current Stage of Development Our software technology of medical imaging and modelling/ simulation is very advanced and can be apply immediately into the market (maybe with some little customisation depending on the requirements of the client). Our hardware technology is in a prototype stage. Collaboration Type Industrial applied R&D Technology Offers · Health 39
  40. 40. Abstract of technology to exploit Development of sophisticated algorithms to integrate and analyze high-throughput (HT) “omics” data for biomedical and biotechnology research Description Bioinformatics group at CEIT-IK4 is an interdisciplinary team formed by researchers with experience in the field of statistics, mathematical modelling and software development. Since 2001, CEIT-IK4 has worked in genomics, transcriptomics, proteomics and metabolomics data integration and analysis. Currently, the integration of these heterogeneous HT “omics” data with genome-scale biochemical networks is one of their most active research areas. Current, data processing, analysis and integration are accomplished in the following technologies: - Microarray: • SNP arrays analysis · Genotyping · Copy number variations • Gene expression analysis • Splicing analysis • MicroRNA arrays - Next Generation Sequencing: • DNA-seq analysis • RNA-seq analysis Promoter organization identification Organization name CEIT-IK4 Contact Gustavo Pego Email gpego@ceit.es Phone +34 660 080 652 Fax +34 943 213 076 Description of the organization CEIT-IK4 is a non-profit research centre. The Centre’s main aim is to carry out applied industrial research projects through close collaboration with Industrial R&D departments on a contractual basis. Activity Industrial applied research Markets tackled - Size - Systems Biology 40 Technology Offers · Health
  41. 41. Innovative Aspects By definition, the Bioinformatics group at CEIT-IK4 aims to develop novel and sophisticated proprietary algorithms to analyze and interpret HT “omics” data. Our methodologies also go beyond statistical approaches, being the hypotheses generation based on complex network analysis and systems biology at the core of our services, which facilitates experimentalist researchers the maximal exploitation of their generated data. Main Advantages The outbreak of genome automation and HT “omics” technologies hasrevolutionizedresearchinbiosciences:medicine,biotechnology, etc. This significant progress has generated an enormous quantity of data that demands highly specialized computer tools for its analysis. The translation of “omics” data into practical knowledge is currently a major issue and the Bioinformatics group at CEIT- IK4 provides different solutions to achieve this goal. Applicability of the technology Our methodology can be applied to different files where high- throughput “omics” data are currently being generated. The collaboration with experimental groups is essential. - Health: • Identification of drug targets. • Drug repositioning. • Clinical Biomarkers. - Biotechnology: • Novel biosynthesis and degradation pathways of interest • Efficient strain optimization • Media design • Bacterial communities Current Stage of Development - Services of microarrays and RNA-seq data analyses are currently developed at commercial stage. - Search for drug targets, drug repositioning and clinical biomarkers are in prototype stage. - Services of DNA-seq data are currently under development. - Services for biotechnology are currently at a more theoretical stage. Exploitation of RTD Results These services come from regional and national projects, as well as our own resources. Intellectual Property Rights CEIT owns proprietary algorithms for these services. Collaboration Type Open to all type of collaboration with industry, research centres or universities. Technology Offers · Health 41
  42. 42. Abstract of technology to exploit CIDETEC-IK4 is developing different research lines for both biomedical and pharmaceutical applications. Those lines are summarized as follows: • Synthesis of Colloidal systems: IK4-CIDETEC synthe- sizes polymer nanoparticles of a wide range of sizes and materials. Small particles < 20 nm in size, submicromiter pH-responsive waterborne colloidal microgels or biodegrad- able nanogels. • Hydrogels: Owner technology of a new family of injectable hydrogels. • Bioactive surfaces: Highly hydrophilic coatings based on hydrogels with tailored properties. In addition, IK4- CIDETEC is expert in several electrochemical technologies with application in the biomedical field: i) Anodization of biocompatible metals, ii) Electrophoretic deposition of biomolecules and ceramic coatings. • Electrochemical biosensors: Development of biosensors based scalable low cost plastic supports applicable for health, agriculture and biotechnological applications. Description IK4-CIDETEC is specialized in the synthesis and characterization of biomaterials. Starting from a single polymer chain, the biomaterials group generates multifunctional colloidal systems of nanometric size (<20nm), produced in water by an easily scalable process for drug-delivery or imaging applications. Other interesting systems consist on submicrometer pH- responsive waterborne colloidal nano/microgels which can swell/Deswell upon pH changes for drug delivery as vehicle or Promoter organization identification Organization name IK4-CIDETEC Contact Dr. Iraida Loinaz Email iloinaz@cidetec.es Phone +34 943 309022 Fax +34 943 309136 Description of the organization IK4-CIDETEC, Centre for Electrochemical Technologies, was created in 1997 as a non- profit Foundation whose mission is to serve the industry to enhance its competitiveness through the implementation of innovative procedures and products. IK4-CIDETEC addresses all electrochemical technologies mainly from an applied research point of view. Its experience and “know-how” covers three main areas of activity: Energy (Batteries, Fuel Cells and Materials for Energy systems), Surface Finishing (Ceramic and Metallic Coatings, Surface Processing) and Materials (Nanomaterials, Biomaterials and Sensors). Activity Industrial applied research in the field of biomaterials. Markets tackled Biotechnology, biomedical, pharmaceutical and food. Size IK4-CIDETEC had an annual turnover of 8,8M€ in 2012 and at the present time employs a highly qualified staff of 126 people (53 PhD included). Biomaterials Synthesis and Electrochemistry 42 Technology Offers · Health
  43. 43. tissue engineering as injectable gels. Another field of interest is the generation of hydrogels. IK4- CIDETEC is owner of a new family of injectable hydrogels with astounding and shear thickening properties to be used as medical device or injectable scaffold in regenerative medicine. IK4-CIDETEC is a Research Center experienced in surface modification and characterisation. Electrochemical and self assembling techniques are evaluated to obtain bioactive coatings over wide range of substrates (metals, glasses, plastics,…) with application in prosthetics, pharmaceutics and biotechnology. The objective is to obtain biomimetic and bioactive surfaces and some technologies have being already optimised to obtain coatings based on titanium anodizing, ceramic electrophoresis. In the last years, IK4-CIDETEC has been applying their knowledge in the field of hydrogels to generate highly hydrophilic polymer coated medical implants to improve biocompatibility, lubrication, reduction of the wear in prosthesis or even to use as photoactive surface with application in the development of microarrays. IK4-CIDETEC has proven expertise in the research and development of electrochemical (bio)sensors, based on screen-printing technology, for the detection of analytes in clinical, environmental and food fields. The capacity for the design and fabrication of our screen-printing electrodes allows the customization for specific applications. Innovative Aspects IK4-CIDETE focuses applied research into industrial applications. This gives the opportunity to develop high quality research and innovative solutions. • Polymer NPs: Polymer nanoparticles based on a single chain collapse to tailor low polydisperse, and very small polymer nanoparticles below 20 nm in size. • Microgels: pH-responsive microgels respond to external pH changes in a accurate way, and can be easily obtained and scalable. Introducing a biodegradable monomers, biodegradable systems can be synthesized. • Hydrogels: The technology is applicable to a wide range of polymers (synthetic and natural polymers) and is based on supramolecular cross-linking. • Highly hydrophilic polymer coatings: IK4-CIDETEC has generated polymer coatings that could reduce 10 times the wear in prosthesis. • Biosensors: Cheap, highly sensitive and portable technology. Main Advantages • Polymer Nanoparticles – Single Chain Collapse route is applicable to a wide range of polymers and it is being applied for the synthesis of multifunctional particles reaching particles below 10 nm size. This technology allows the fabrication of NPs with polydispersities below 1.1 in order to reach optimal solutions in applications like drug delivery and molecular imaging. • Hydrogels – The technology is applicable to a wide range of polymers (synthetic and natural polymers). By combination of their two components the hydrogels form in seconds and there injectable. They have self-healing properties, after breaking in pieces, they regenerate their mechanical properties. Those systems show shear thickening properties, and their mechanical properties can be adjustable. • Surface Biofunctionalization - Electrochemical Technologies offerscalable,robust,ad-hoccoatingdesignforbiomedicalfield. The highly hydrophilic coatings with reduced friction coef- ficient that could reduce wear in prosthesis ten times. It could also include multifunctionality and control biofouling or even prevent from infections. Technology Offers · Health 43
  44. 44. • Electrochemical Biosensors – IK4-CIDETEC builds their own plastic sensor platforms by low cost screen printing processes. This technology has been optimized in terms of sensibility and selectivity. IK4-CIDETEC capacities cover all the value chain from design until integration. In hence offers reduced time-to-market products. Applicability of the technology • Pharma and Cosmetics: Multifucitonal NPs for therapy and imaging in cancer. Drug nanoformulation for topical doses (inhalatior, skin). Microgels /capsules for targeted drug delivery. Nanoformulation of antibiotics. Hydrogels. Electrochemical biosensors for diagnosis. • Biotech: Injectable hydrogels for tissue engineering. Stimuli responsive microgels for enzyme encapsulation. Photoactive surfaces for MALDI analysis. Controlled release of growth factor. • Medical Devices: Highly biocompatible bioactive coatings. Coatings for implants to reduce friction and wear. Antifouling coatings. Antibacterial coatings. Injectable hydrogels. Anodized and biofunctional coatings. Ceramic coatings prepared by electrophoresis. • Other: Chemical Industry: Antifouling coatings. Food: Neutraceutical encapsulation. Biosensors. Agriculture: Gel formulations. Current Stage of Development The technologies offered in the biomedical field have been optimised at lab scale and they are being oriented to real industrial applications under the frame of different private contracts with industrial companies. Intellectual Property Rights The intellectual property rights are designed and agreed for each specific collaboration. Collaboration Type IK4-CIDETEC collaborates with other technology agents (University, Laboratories, Research Centers,...) in the frame of different Projects in order to develop novel technologies for further industrial competitive and high added value applications. In the case of industrial companies, the collaborations are mainly made under private and confidential contracts. 44 Technology Offers · Health
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  46. 46. Abstract of technology to exploit Uniquely capable of offering the complete package of consultancy and hands-on support for drug development from molecule to regulatory approval and from titter to the adult and the child. The Dynakin group comprises a GLP biolab, a clinical trial CRO (Clinical Research Organization), a full MBDD (model based drug development) strategic consultant team and a regulatory affairs advisor team with direct experience in complex applications. The Dynakin group also covers information technology for custom software for industrial drug development and for clinical post marketing (DynaPRED®). The Dynakin business model is proven by being one of the fastest growing companies in the sector in Europe. Over 80% of our (repeat!) clients are based in Germany, Switzerland or the UK. Description Dynakin’s services cover all aspects of development: GLP wet lab, some in vitro and cell line testing then also population pharmacokinetic (PK), pharmacodynamic (PD) (PK/PD) analysis, regulatory standard Modeling & Simulation, clinical trial protocol design, preparation and CT execution and regulatory report preparation and presentation to the agencies. Dynakin’s Drug Modeling & Consulting (DMC) group offers a wide range of strategic advice services based on extensive expertise in drug development strategy and regulatory aspects and international class expertise in MBDD via M&S (modelling and simulation) technologies. The combination of our regulatory and CT design expertise and MBDD improve rationalization of strategic decision making, reducing development costs and candidate attrition. The professional expertise of Dynakin in the modelling & simulation field covers complete study design and Promoter organization identification Organization name Dynakin, S.L. Contact Nerea Leal Email nleal@dynakin.com Phone +34 944 04 55 04 Fax +34 946 55 94 63 Description of the organization Private biotechnological company Activity trategic Decision Advisors Drug for Drug Development and Start Up Markets tackled Germany, Switzerland, UK, Spain Size 20 Dynakin, strategic decision assistance for drug development via regulatory, Modeling & Simulation, Clinical Trial design and execution and GLP Biolab departments in four central European countries 46 Technology Offers · Health
  47. 47. optimization, assistance in protocol preparation, final reporting and regulatory submission. DMC has extensive experience in the design, execution, MBDD consulting and regulatory chaperon related with these aspects: • Protein mapping • Pre-Clinical • FTIM • Clinical • Clinical Trial • Bioequivalence • Pharmacokinetic, Pharmacodynamics • Disease progression • Competitor therapeutic margin • Logistics, Quality, Vigilance • Biostatistics • Pharmacoeconomics • PK/PD Analysis and Modeling • Medical Reporting • Regulatory Reporting • Regulatory Presentation • Pediatric Investigation Plan Dynakin’s products include: Web based applications for facilitating marketing and clinical (post marketing) use (DynaPRED® product line). Custom made software for high end industrial development that includes data management and modelling and simulation. Commercial standard metadata bases directly applicable to decision making on specific therapeutic areas for comparators and disease progression. In addition, all our services and most of our products are flexibly adjusted to the clients need in more dimensions (cost, time) than by any other similar organization. Innovative Aspects Dynakin is unique in having tried a risky model of bringing together under the same roof a very wide range of international experts in drug development while investing heavily in industrial development support infrastructure (GLP Biolab). Throughout our own growth, a managerial focus was in avoiding the collateral of a heavy overhead structure thus now Dynakin offers maximal productivity at the lowest time and money cost for the client. The outcome is a success for this business of model of having under the same roof from pharmacologists to regulators to physicists and computer scientists (all PhD’s) and from high tech wet lab to a world class consultation team bound by the same internal vision of our clients being able to rely confidently and completely on our assistance. Most of our clients are word of mouth or repeat from major first class industrial (pharma) nations in Europe. The whole is complemented by a line of product supporting pharmacoeconomic based marketing. Main Advantages At this point in time there is no single pharmaceutical company independent of size that does not request at some point external expertise in decision making. In no other industry such wide discipline matching of top class expertise is required to have a chance to approve a drug while surviving financially. Technology Offers · Health 47
  48. 48. Far more so for virtual or start up companies who cannot and need not acquire all the expertise required for drug development. Dynakin can resource any or all development tasks for our clients flexibly and at the pace required by the client and not at ours! Applicability of the technology Dynakin collaborates with client expert teams focusing solely on a specific aspect (Modelling & Simulation, Regulatory preparation, clinical trial design, GLP lab) or with is fully qualified by the client to complement that entire effort or a combination or all of the above tasks for development. Our applicability lies in our flexibility! Current Stage of Development All Dynakin services are fully mature and tested. Our products undergo continues improvement as we are also a “commercial research organization”. Over 30% of Dynakin’s budget is invested keeping our products and services in the forefront of the rapidly changing pharmaceutical development field. The DynaPRED® series of products is currently under nearly complete rebuild from the ground up to provide a set of stand- alone user- friendly web-based tools for the clinician at bed side for adults and children to neonates. The products, constituting an industrial secret of the company, integrate Dynakin’s own therapeutic area expertise to guide individualized patient dosing decision. This second generation of routines (end of 2011) will be easily integrated into programmable dosing pumps. Exploitation of RTD Results The majority of the DynaPRED® line (specific therapeutic areas) is Dynakin owned and developed. Parts of the extended application (neonates, pumps) are co-financed and owned by public and private entities. Intellectual Property Rights Trade secret. Collaboration Type Dynakin is interested in collaborating with industry partners in life sciences and to offer their services to the pharmaceutical laboratories. 48 Technology Offers · Health
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  50. 50. Abstract of technology to exploit Our scientific and technical expertise in the fields of molecular biology, microbiology, immunochemistry and enzymology enable us to develop innovative biological assay-based biodetection systems (including lateral flow strips or the technique known as immuno-qPCR) and to implement them for use as analytical tools with numerous applications in human, animal and environmental health and food traceability and safety. Our activities also cover strategies for optimising and characterising immobilisation processes for biorecognition molecules on surfaces and the development of biodetection systems which may require the modification and/or functionalisation of biorecognition molecules. Likewise, we aim to incorporate biological recognition mechanisms into devices. Our current goal is to develop biosensors. These devices combine the biological sensor (antibodies, enzymes, nucleic acids, amongst others), the signal transducer and the detector into a single system. Such devices have numerous biodetection applications and offer advantages such as high specificity and sensitivity, shorter analysis times, portability, and the possibility for automation. Description Development of biodetection systems: • RT-PCR • Inmuno-qPCR • Surface plasmon resonance (SPR) • Lateral flow with fluorescent microspheres • High Resolution melting (HRM) Validation of sensor devices: microPCR, magnetic sensors, electrochemical sensors. Identification of target molecules or analytes of interest. In Vitro Diagnostic tests Promoter organization identification Organization name GAIKER-IK4 Contact Maitane Ipiñazar Email mark@gaiker.es Phone +34 600 23 23 Fax +34 600 23 24 Description of the organization GAIKER-IK4 Technology Centre is a non-profit foundation devoted to the up-take of own knowledge and to the development of new technologies that are later transferred to customers coming from sectors such as the Pharmaceutical Industry, Chemical Industry, Human and Animal Health, Engineering and Consultancy Firms, Public Administrations, Automotive Industries, Construction, Packing and Packaging, and Home Appliances, amongst others. From 1985, the Centre has carried out more than 1.400 R&D Projects related to its Knowledge Areas: Biotechnology, Environment and Recycling and Plastics and Composites. Besides its activity in R&D, GAIKER-IK4 offers to its customers Advisory and Technical Assistance Services, Certified Analysis and Tests and Official Recognition of Products, as well as Training and Dissemination Service. GAIKER-IK4 was awarded in 2008 by the European Foundation for Quality Management (EFQM) with the “Prize Winner” for the best European organisation in “Management for Process and Facts”. GAIKER-IK4 also has certifications such as ISO 9001, GLP, ISO 14001, EMAS, which show its strong commitment with quality and continuous improvement. (www.gaiker.es) Activity R&D Markets tackled Pharmaceutical, Cosmetics, Chemical, Food Size 117 50 Technology Offers · Health
  51. 51. Identification of antigen markers using bioinformatic-based tools. Identification and characterisation of target molecules of diagnostic/prognostic interest in real-life samples (saliva, urine, tears, serum…). Combinatorial biochemistry-based molecule development. • Aptamer development • Peptide development (phage display) Antibody development • Polyclonal (pseudo-monoclonal) antibody development Surface immobilisation processes for biorecognition molecules • Immobilisation of biorecognition molecules on gold • Immobilisation of biorecognition molecules on microsphere surface (carboxyl, silica, polystyrene…) Innovative Aspects The biosensor-devices combine into a single system the biological recognition bio-elements with the signal transducer and the detector. These devices have numerous biodetection applications and offer advantages such as high specificity and sensitivity, shorter analysis times, portability and the possibility for automation. GAIKER´s key strength is the availability to adapt to the customer needs and proactive thinking on behalf of customer, efficient R&D project management and on-time deliveries. Main Advantages We count on our high qualified personnel working on different biological specialties as cellular, biochemical, molecular, genetic, microbiological, genomic and proteomic technologies in our ultimate laboratories with the latest vanguard equipment. Our main equipment: • SURFACE PLASMON RESONANCE (ProteOn XPR36 Protein Interaction Array System) • DNA MICROARRAY SCANNER (AGILENT G2565CA) • RNA/DNA EXTRACTION ROBOT (QIACUBE) • PROTEOMIC PLATFORM • RT-PCR • FLUORESCE MICROSCOPY AXIO OBSERVER Z1 • CONFOCAL MICROSCOPY. ZEISS LSM 700 • BIODOT • AKTA EXPLORER • BIODOT- INMUNOCHROMATOGRAFY STRIP TEST PRODUC- TION Applicability of the technology Pharmaceutical • Biotech • Clinics/Hospitals • Medical devices and medical equipment • Environment enterprises • Agro-food industry • Analytical testing laboratories Current Stage of Development R&D Collaboration Type Pharmaceutical, Biotech industry, medical devices and medical equipment industry, public and private hospitals, environmental and agro-food industries, academia and R&D centres. Technology Offers · Health 51
  52. 52. Abstract of technology to exploit The Biotechnology Division performs Good Laboratory Practice (GLP)-certified in vitro studies during the toxicology, efficacy and pharmacokinetic testing of pharmaceuticals, nutraceuticals and cosmetics. We also apply genomic- and proteomic-based technologies to pharmacogenomic, molecular-diagnosis and genetic-susceptibility assessments. Description ADME –PK In Vitro permeability: • PAMPA • CACO-2 permeability • MDCK permeability • In vitro transporter assays · ATPase assays · Vesicular transport assays In vitro metabolism: • Drug-drug interaction assays · Cytochrome P450 inhibition: - IC50 determination - Ki determination · Cytochrome P450 induction · Cytochrome P450 isoforms identification · P-glycoprotein inhibition • Cytochrome P450 reaction phenotyping • Microsomal stability Preclinical in vitro services Promoter organization identification Organization name GAIKER-IK4 Contact Maitane Ipiñazar Email mark@gaiker.es Phone +34 600 23 23 Fax +34 600 23 24 Description of the organization GAIKER-IK4 Technology Centre is a non-profit foundation devoted to the up-take of own knowledge and to the development of new technologies that are later transferred to customers coming from sectors such as the Pharmaceutical Industry, Chemical Industry, Human and Animal Health, Engineering and Consultancy Firms, Public Administrations, Automotive Industries, Construction, Packing and Packaging, and Home Appliances, amongst others. From 1985, the Centre has carried out more than 1.400 R&D Projects related to its Knowledge Areas: Biotechnology, Environment and Recycling and Plastics and Composites. Besides its activity in R&D, GAIKER-IK4 offers to its customers Advisory and Technical Assistance Services, Certified Analysis and Tests and Official Recognition of Products, as well as Training and Dissemination Service. GAIKER-IK4 was awarded in 2008 by the European Foundation for Quality Management (EFQM) with the “Prize Winner” for the best European organisation in “Management for Process and Facts”. GAIKER-IK4 also has certifications such as ISO 9001, GLP, ISO 14001, EMAS, which show its strong commitment with quality and continuous improvement. (www.gaiker.es) Activity R&D Markets tackled Pharmaceutical, Cosmetics, Chemical, Food Size 117 52 Technology Offers · Health
  53. 53. • Hepatocyte stability • Metabolities profiling and identification • Protein binding • Plasma protein binding TOXICOLOGY SERVICES Cytotoxicity • MTT • XTT • Neutral red • Alamar Blue • LDH • MTS Cellular function analysis • Mitochondrial functionality • Oxidative stress • Intracellular glutathione • Calcium flux • Lipid stability • Signals transduction • Intracellular pH Genotoxicity • Ames test (OECD TG 471) • In vitro mammalian cell gene mutation test (OECD TG 476) • In vitro mammalian cell micronucleus test (OECD 487) Organ toxicity • Hepatotoxicity • Cardiotoxicity • Skin toxicity • Ocular toxicity Toxicological gene regulation • Toxicogenomics • qRT-PCR CELLULAR ACTIVITY Proliferation Migration Innovative Aspects Our high qualified scientists work on different biological specialties as cellular, biochemical, molecular, genetic, microbiological, genomic and proteomic technologies in our ultimate laboratories. Our main equipment: UPLC MS/MS HPLC/DAD/MS HPLC/FL GC/MS FPLC SURFACE PLASMON RESONANCE (ProteOn XPR36 Protein Interaction Array System) Technology Offers · Health 53
  54. 54. CYTOMICS FC 500-MC FLOW CYTOMETRY FLUORESCE MICROSCOPY AXIO OBSERVER Z1 CONFOCAL MICROSCOPY. ZEISS LSM 700 CELL CULTURE BIOBANK DNA MICROARRAY SCANNER (AGILENT G2565CA) RNA/DNA EXTRACTION ROBOT (QIACUBE) PROTEOMIC PLATFORM q-PCR, HRM-PCR Main Advantages GAIKER IK4 complies with current requirements for GLP while maintaining efficiency. We count on our high qualified personnel and latest vanguard equipment to develop customized assays for cosmetics, pharmaceuticals, medical devices and functional food assessments. GAIKER´s key strength is the availability to adapt to the customer needs and proactive thinking on behalf of customer, efficient R&D project management and on-time deliveries. • DNA MICROARRAY SCANNER (AGILENT G2565CA) • RNA/DNA EXTRACTION ROBOT (QIACUBE) • PROTEOMIC PLATFORM • RT-PCR • FLUORESCE MICROSCOPY AXIO OBSERVER Z1 • CONFOCAL MICROSCOPY. ZEISS LSM 700 • BIODOT • AKTA EXPLORER • BIODOT- INMUNOCHROMATOGRAFY STRIP TEST PRODUC- TION Applicability of the technology • Pharmaceutical • Biotech • Clinics/Hospitals • Medical devices and medical equipment • Environment enterprises • Agro-food industry • Analytical testing laboratories Current Stage of Development R&D Collaboration Type Pharmaceutical, Biotech industry, medical devices and medical equipment industry, public and private hospitals, environmental and agro-food industries, academia and R&D centres. 54 Technology Offers · Health
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  56. 56. Abstract of technology to exploit Cleaning and Detergency In this field of application we develop technologies extendable to industries for the production of biological agents, essentially micro-organisms and enzymes, with cleaning and detergency activities. We select the agents that provide the greatest yield for different environmental conditions of temperature, ph, nutrients, toxic elements, light, etc. Description Our lines of technological activity are: • Optimal determination of the activity of industrial enzymes and their conditions of performance and use. Enzymatic activities: proteolytic, lipolytic, amyolytic, cellulolytic. • Optimization of enzyme performance conditions with a view to appropriate formulation of the end product. Compatibility of biological product formulations (enzymes and microorganisms). • Search for super-degrading microorganisms by means of the exhaustive and systematic screening of microorganisms in different habitats where the desired activities are high: lipolytics, proteolytics, amylolytics, cellulolytics, or more specific activities such as keratinolytics (for unblocking products) or pesticide degrading. • Cloning of microorganisms that produce modified enzymes in such a way that they act in concentrations other than native and are therefore more favourable for formulation of the product. Industrial biotechnology Promoter organization identification Organization name GAIKER-IK4 Contact Maitane Ipiñazar Email mark@gaiker.es Phone +34 600 23 23 Fax +34 600 23 24 Description of the organization GAIKER-IK4 Technology Centre is a non-profit foundation devoted to the up-take of own knowledge and to the development of new technologies that are later transferred to customers coming from sectors such as the Pharmaceutical Industry, Chemical Industry, Human and Animal Health, Engineering and Consultancy Firms, Public Administrations, Automotive Industries, Construction, Packing and Packaging, and Home Appliances, amongst others. From 1985, the Centre has carried out more than 1.400 R&D Projects related to its Knowledge Areas: Biotechnology, Environment and Recycling and Plastics and Composites. Besides its activity in R&D, GAIKER-IK4 offers to its customers Advisory and Technical Assistance Services, Certified Analysis and Tests and Official Recognition of Products, as well as Training and Dissemination Service. GAIKER-IK4 was awarded in 2008 by the European Foundation for Quality Management (EFQM) with the “Prize Winner” for the best European organisation in “Management for Process and Facts”. GAIKER-IK4 also has certifications such as ISO 9001, GLP, ISO 14001, EMAS, which show its strong commitment with quality and continuous improvement. (www.gaiker.es) Activity R&D Markets tackled Pharmaceutical, Cosmetics, Chemical, Food Size 117 56 Technology Offers · Health

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