Services and R&D for the Pharmaceutical Industry

Services and R&D for the Pharmaceutical Industry

www.tecnalia.com

YOUR BEST CHOICE FOR PHARMACEUTICAL RESEARCH AND DEVELOPMENT We understand and are committed to your business.

We are flexible in relational-contractual models and proactive troubleshooting of your R&D projects.

We offer our knowledge, capabilities, accreditations, expertise and know-how to our customers, for an efficient access of their products to the market.

Services and R&D to help you maximize your business opportunities.

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THIS IS US, THIS IS TECNALIA

IDEAS THAT CREATE VALUE

Inspiring Business VALUES

We identify and develop business opportunities through applied research. Inspiring Business is a different, unique vision: we visualise ideas that generate value and provide creative technological solutions to produce real results.

6 BUSINESS DIVISIONS

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COMMITMENT TO THE FUTURE

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SUSTAINABLE CONSTRUCTION

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BUSINESS PERSPECTIVE

2

ENERGY AND ENVIRONMENT

3

RESEARCH TENACITY

3

ICT-EUROPEAN SOFTWARE INSTITUTE

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EFFICIENT CREATIVITY

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INDUSTRY AND TRANSPORT

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FLEXIBILITY

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HEALTH

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CONNECTIVITY

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TECHNOLOGICAL SERVICES

INTERNATIONAL PRESENCE

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TECNALIA Research & Innovation is the first privately funded applied research centre in Spain and one of the leading such centres in Europe. A combination of technology, tenacity, efficiency, courage and imagination.

SALES NETWORK ASSOCIATED INNOVATION CENTRES BRANCHES ABROAD ALLIANCES HEADQUARTERS

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

At TECNALIA we are organised in 6 fully interconnected Business Divisions. Cooperation works thanks to the transversality of teams, projects and clients collaborating with each other, combining expertise and commitment. Our best asset is our team, made up of more than 1,500 experts who work to transform technology into GDP in order to improve people's quality of life by generating business opportunities for companies.

We are committed to the future, society, our planet and our environment. This responsibility provides focus to our values and reinforces our activities.

OUR ACTIVITY IN FIGURES

TECNALIA I INSPIRING BUSINESS

"TECNALIA transforms Technology into GDP to improve people's quality of life by generating business opportunities for Companies"

DOCUMENT PUBLISHED IN SEPTEMBER 2016

ONE HUNDRED AND TEN

1 1,500

FIRST SPANISH PRIVATE ORGANISATION IN FINANCIAL RETURN, PROJECTS APPROVED AND LED WITHIN THE EC 7FP

EXPERTS ON STAFF

MILLION EUROS INCOME

WORKING TOWARDS A COMMON GOAL:

TO GENERATE BUSINESS OPPORTUNITIES THROUGH APPLIED RESEARCH.

BU SIN ES

4 APPROACHES TO THE WAY WE WORK WITH COMPANIES TECHNOLOGICAL SERVICES

INS

PIR IN G

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VENTURES

YOUR PROJECT R&D PROJECTS

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TECHNOLOGY AND INNOVATION STRATEGY

Services and R&D for the Pharmaceutical Industry TECNALIA offers technological solutions across the entire value chain of drug development: • Human medicines.

• Cosmetics.

• Medical devices.

• Veterinary medicines.

• Food supplements.

HUMAN MEDICINES

MEDICAL DEVICES

OUR LABORATORIES ARE CERTIFIED IN ACCORDANCE TO SPECIFIC STANDARDS AND PRACTICES FOR PHARMACEUTICAL PRODUCTS: • ISO 9001.

• Good Manufacturing Practices (GMP) Pharmaceutical development and manufacturing.

• Good Laboratory Practices (GLP) - Pharmaceutical development.

• Spanish Medicines Agency (AEMPS) inspection with positive result - Clinical trials and Bioanalysis.

• We work under Good Clinical Practices (GCP) - Clinical Trials Unit.

LINES OF INNOVATION / AREAS: • New pharmaceutical release forms.

• Reformulation of active ingredients.

• "Reprofiling" of brand drugs.

• Clinical trials of inhaled medications.

• Development and clinical validation of food supplements.

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FOOD SUPPLEMENTS

COSMETICS

VETERINARY MEDICINES

SERVICES AND R&D FOR THE PHARMACEUTICAL SECTOR 01.

Pharmaceutical Development

02.

Manufacturing

GALENIC DEVELOPMENT

PILOT BATCHES & BATCHES OF REGISTRATION

ANALYTICAL DEVELOPMENT

INDUSTRIAL BATCHES: MANUFACTURING FOR THIRD PARTIES

STABILITY STUDIES

BATCHES FOR CLINICAL TRIALS

INDUSTRIAL SCALING

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Clinical Trials

04.

Pharmacogenetics

BIOEQUIVALENCES

GENETIC DIAGNOSIS

COMPANION DIAGNOSTICS

PHASE I, II, III & IV CLINICAL NUTRITION

• Monitoring of allergenic extracts.

CLINICAL VALIDATION

• Diagnostic, prognosis and response to drug tests.

BIOANALYSIS

• Companion Diagnostics.

EXTERNAL STUDIES MANAGEMENT

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Other Services DEVELOPMENT & EFFICACY OF OTC PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS GENETIC DIAGNOSIS

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

TECNALIA I INSPIRING BUSINESS

TECNALIA offers independent, efficient and cost effective testing and analysis services that will accelerate the introduction of your pharmaceutical product on the market.

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Pharmaceutical Development

GALENIC DEVELOPMENT

ANALYTICAL DEVELOPMENT

• Preformulation studies.

• Monitoring of the first industrial manufacturing batches.

• Design and galenic development of innovative, generic and advertising (OTC) medicines.

• Design and galenic development of new dosage forms.

• Development and validation of analytical techniques.

• Compatibility studies of active ingredients and excipients.

• Metal Impurities Analysis by ICP-OES.

• Design of manufacturing processes.

• Transfer of manufacturing technology and "in situ" support.

• Reporting Expert.

• Patents study.

TECNALIA´s Pharmaceutical Development Laboratory is accredited by the Spanish Medicines Agency (AEMPS) in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

We offer solutions in several dosage forms formulation: • Solids (tablets, capsules, sachets, etc.)

• Liquids (suspensions, solutions, syrups, etc.).

• Semi-solids (gels, creams, ointments, etc.).

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• Characterization of raw materials according to Pharmacopoeia.

• Quantification of active ingredients, impurities and degradation products in raw materials and medicines.

• Transfer of analytical techniques.

• In vitro dissolution profiles.

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

TECNALIA I INSPIRING BUSINESS

TECNALIA has the experience and necessary infrastructure to carry out the development of the formulation of a wide range of products.

STABILITY STUDIES

EQUIPMENT

• Electronic scales.

• Differential Scanning Calorimetry (DSC).

• Volumenmeter.

• V Mixer.

• Eccentric press machine and rotary press machine.

• Automatic encapsulating.

• Fluid bed.

• Paila coating.

• Rotolab.

• Lyophilizer.

• Spray-Dryer.

• Blistering machine.

• Extruder-spheroniser.

• Oven muffle.

• Climatic chambers.

• Chromatographs for UHPLC, HPLC (UV / VIS and fluorescence) and for HPLC -MS. • Dissolution tester and fraction collector.

Stability Studies in short and long term, according to ICH standards.

• Batchs of Registration.

• Industrial batches of finished product (Release, changes, etc.).

• Spectrophotometers.

• Durometers.

• Friability tester.

• Solid forms disintegration tester.

• Electronic Moisture Analyzer.

• Ongoing.

• Rheometer.

• Bulk product.

• Viscometer.

• External management of stabilities.

• Laser Diffraction Particle size Analyser and coulter.

• Karl-Fischer.

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Manufacturing

PRODUCTS

• Human medicines.

• Medical devices.

• Food supplements.

• Cosmetics.

• Veterinary medicines

Manufacturing of Batches for Clinical Trials / • Importation of active substances and medicines.

• Manufacturing of placebos, medicines, food supplements.

• Design of blinding strategy.

• Labelling for primary and secondary packaging.

• Storage Good Manufaturing Practices (GMP) conditions.

• Shipping management to the different centers.

• Return, reconciliation and destruction of medicines.

Contract Manufacturing of Industrial Batches for Third Parties / • Quality control and certification of active substances, excipients and finished products.

• Manufacturing in GMP conditions.

• Validation of cleaning processes.

Pilot Batches and Registration Batches /

• Analysis and batch release.

• Manufacture in compliance with the principles and guidelines of GMP for medicinal products.

• Storage in GMP conditions.

• Transfer of analytical techniques.

• Scaling up from laboratory batches to industrial batches.

Industrial Scale /

• Validation of new manufacturing and packaging processes.

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TECNALIA has a unique facility (Pilot Plant / Pharmaceutical Laboratory) to provide ample opportunities for scaling and manufacturing of medicines, medical devices, cosmetics and food suplements, always in the most stricter compliance of GMP certification.

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

AUTHORIZED DOSAGE FORMS

TECNALIA I INSPIRING BUSINESS

EQUIPMENT

• Solids (tablets, coated tablets, capsules, etc.).

• Mixing: Rulon, V, Vima Cyclops.

• Liquids (solutions, syrups, drops...).

• Drying: Static, Fluid Bed.

• Semi-solids (creams, emulsions, gels, etc.).

• Capsules filling: Manual, Macofar

• Granulation: High Speed, Oscillating.

CD-40.

• Tabletting machine: Kilian.

• Tablet coating: IMA-70 drum coating.

• Liquids: 100L, 2.400L reactors.

• Semisolids: 10L, 300L, Mixer.

• 1st Packaging: - Tube: Alu, PE. - Bottles: glass, PET. - Blister packing machine ALU/ALU PVC/ALU. • 2nd Packaging: - Cartoner.

- Labeling.

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Clinical Trials

TECNALIA is part of unique Clinical Trials Unit of the Basque Country.

It is located at the Araba University Hospital (HUA).

TECNALIA participates in the Research Commission of the HUA.

BIOEQUIVALENCE STUDIES

CLINICAL TRIALS IN PHASE I

Extensive experience in bioequivalence developing of all kinds of drugs administered by different routes and experimental designs, including studies with large numbers of volunteers executed in one or more stages:

• First in human (FIH).

• Sublingual.

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• Interactions (Drug / Food / Alcohol).

• Drug tolerability and safety.

• Inhalers.

• Orals.

The extensive experience, the quality, and the response capacity and the great potential for recruitment are the uniqueness of the Clinical Trials Unit at TECNALIA, the only one in the Basque Country.

• Pharmacokinetics / Pharmacodynamics.

• Parenteral.

CLINICAL TRIALS IN PHASE II, III & IV

• Hormones.

• …

TECNALIA disposes central services from the Araba University Hospital (HUA), necessaries for the selection and follow up of participants in the trials within the medical specialities that comprise the HUA.

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

TECNALIA I INSPIRING BUSINESS

TECNALIA answers Bioequivalence Studies to uniquely demanding products: Inhaled Medications.

CLINICAL NUTRITION

TURNKEY PROJECTS

MANAGEMENT OF EXTERNAL STUDIES

• Design and / or evaluation of the study documentation.

• Collaboration in the design of the study documentation and management of authorizations and contracts.

• Managing regulatory authorities and IRB/IEC submissions and approvals.

Clinical trials designed to demonstrate the safety and efficacy of active ingredients, food supplements and functional foods.

• Monitoring.

• Database design, data entry and queries management.

• Management of the Trial Master File (TMF).

• Pharmacokinetics (PK) analysis, pharmacodynamic (PD) analysis and PK / PD relationship.

• Data management.

• Review of the Clinical Study Report (CSR).

• Analysis and statistical reports.

• Writing and / or review of final reports.

TECNALIA is spezialised in the design, implementation, coordination, monitoring and analysis of clinical trials of of high quality nutritional clinical trials.

The Clinical Trials Unit has experience in developing clinical trials with nutritional supplements for top companies in the national and international market.

CLINICAL VALIDATION

Biomarkers, prognosis/diagnostics systems and medical devices.

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Pharmacogenetics

COMPANION DIAGNOSTICS

The activities of TECNALIA´s Molecular Biology Grop on the Biomedical sector aim to bring P4 Medicine (Predictive, Preventive, Personalized and Participatory) to patients and professionals.

In this regard, the Genetics and Molecular Biology Laboratory devotes a significant portion of its resources to develop assays and in vitro tests for disease diagnosis, prognosis and prediction of drug response (Companion Diagnostics).

Personalized / • Proper treatment at the right dose.

• To the right patient / disease.

• At the right time.

• For the right outcome.

Predictive / • Prediction of response to therapy.

• Efficiency vs toxicity.

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Evaluate risk and predisposition to certain diseases.

It allows the adoption of preventive measures to delay, or even eliminate, the occurrence of the disease or early diagnosis.

Participatory / To involve the patient in the management of his/her disease: treatment options, prevention strategies, monitoring of the disease and risks.

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

TECNALIA I INSPIRING BUSINESS

GENETIC DIAGNOSIS

TECNALIA´s Laboratory of Genetics and Molecular Biology is member of the European Molecular Genetics Quality Network (EMQN).

The European Molecular Genetics Quality Network

Equipment / Laboratory (220 m2) consists of three different areas, two of which are intended to the preparation and handling of samples and are equipped with systems to control air temperature, humidity and pressure.

Among the main equipment includes: • Next Generation Sequencing.

The laboratory also develops a strong activity in the field of Genetic Diagnosis, focused on three main areas:

• Microarray Scanner.

• 3130xl Genetic Analyzer.

• Real Time PCR.

1. Diagnosis of hereditary syndromes (tumoral and non-tumoral).

• Flow cytometer.

2. Diagnosis of neoplastic diseases.

• Microplate reader.

3. Preimplantation genetic diagnosis.

• Thermalcyclers.

• Image analysis system.

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Other Services

DEVELOPMENT AND EFFICACY OF OTC (OVER THE COUNTER) PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS

• Insect skin repellent.

• Pediculicides: ovicidal and adulticide.

• Treated fabrics.

• Other “indoor” and “outdoor” products of personal protection (aerosols, diffusors, baits, coils, wristbands and others).

ACCREDITATIONS AND RECOGNITIONS •

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Ethics committee approval for the use of volunteers.

Facilities and protocols following World Health Organization (WHO) and the Spanish Agency of Medicines and Medical Devices (AEMPS).

SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY

TECNALIA I INSPIRING BUSINESS

Customers´ References

PHARMACEUTICAL INDUSTRY

BIOMEDICAL SECTOR

ABEDUL

LABORATORIOS CINFA, S.A.

CLÍNICA QUIRÓN

ADVANCED MARKER DISCOVERY, S.L.

LABORATORIOS DIATER, S.A.

CLÍNICA VICENTE SAN SEBASTIÁN

AJL, S.A.

LABORATORIOS FAES-FARMA, S.A.

HOSPITAL DEL MAR

ARACLON BIOTECH, S.L.

LABORATORIOS LICONSA, S.A.

HOSPITAL DONOSTIA

BIAL INDUSTRIAL FARMACÉUTICA, S.A.

LUSOMEDICAMENTA

BIOKILAB, S.L.

MITELOS

HOSPITAL UNIVERSITARIO DE ARABA (HUA)

CAFOSA

NEURON BIO

CYNDEA PHARMA, S.L.

NIRCO

DYNAKIN, S.L.

NORAY BIOINFORMATICS, S.L.

ESTEVE

NOVO NORDISK PHARMA

EXPERIOR

OJER PHARMA

FARMALIDER

ONE DOSE PHARMA, S.L.

FERRER

PENSAN PHARMA

FROSST IBERICA, S.A.

PRAXIS BIOPHARMA RESEARCH INSTITUTE

FUND. VASCA DE INNOV. E INVEST. FUNDACIÓN EUSKOIKER GALENICUM HEALTH, S.L. GEISER-PHARMA, S.L. GENETADI BIOTECH, S.L. GES GENÉRICOS IDIFARMA KERN PHARMA KYMOS PHARMA SERVICES, S.L. LABORATORIOS ALDO UNIÓN LABORATORIO ESTEDI, S.L. LABORATORIOS BIOMENDI S.A.U.

IVF DONOSTI IVF SPAIN ONKOLOGIKOA

PRAXIS PHARMACEUTICAL, S.A. QUIMUNSA SORIA NATURAL STADA STEMTEK THERAPEUTICS, S.L. TEVA TRANSBIOMED, S.L. UNIVERSITY OF COPENHAGEN, FACU URIACH VEGAL 15

TECNALIA Parque Científico y Tecnológico de Gipuzkoa Mikeletegi Pasealekua, 2 E-20009 Donostia-San Sebastián - Gipuzkoa (Spain) T 902 760 000* T +34 946 430 850 (International calls) www.tecnalia.com EIDER LARRARTE Health and Quality of Life Area Director eider.larrarte@tecnalia.com GREGORIO ORTIZ DE URBINA Health and Quality of Life Area Market Manager goyo.ortizdeurbina@tecnalia.com SERVICES AND R&D FOR THE PHARMACEUTICAL INDUSTRY