Introduction
The Common Support Services bring together a set of transverse structures They provide support to the research community in the development of their scientific activity.
The objective of these Services is to make available to researchers a wide range of resources that facilitate the development of quality research projects, the translation of results to clinical practice and their transfer to the productive sector.
Pharmacogenetics and Pharmacogenomics Unit in Aragon (FARMAGEN-Aragón) IIS Aragón
Principal Investigator: Maria Luisa Bernal Ruiz
Contact email: farmagen@iisaragon.es
La Pharmacogenetics and Pharmacogenomics Unit (FARMAGEN) The IIS Aragón offers research centers, companies, hospitals and other professionals a specialized pharmacogenomic analysis service, aimed at achieving a personalized therapeutic treatment, which avoids as much as possible adverse reactions and therapeutic failures of medications, thus offering a more personalized medicine and added value by providing data that contributes to reducing spending for Health Systems
Pharmacogenomic studies will be based on the recommendations, regulations and protocols published by international agencies (Food Drug Administration, FDA, European Medicines Association, EMA) and national agencies, specifically the SCReN platform (Spanish Clinical Research Network) in collaboration with the “Sociedad Spanish Pharmacogenetics and Pharmacogenomics (SEFF)”
PHARMAGEN is a service that is aimed at research projects and companies whose main objective is, the study and search for biomarkers which can range from therapeutic targets for new drugs to markers for diagnosis, prognosis and prevention of diseases. In addition, to search for and determine biomarkers that help adjust treatments based on existing drugs.
On the slope of the Clinical trials involves identifying, in the early phases of the Trial, patients who require different dosages, which implies being able shorten and simplify the following phases of the trial, increasing the probability of achieving and demonstrating greater efficacy and less toxicity of the drug. This translates into a great advantage for new drugs since having a validated test at the time of requesting the registration of a new drug gives it added value of innovation and differentiation.
In addition, the clinical validation of pharmacogenomic biomarkers contributes, from a translational point of view, to a better use of medications in the hospital setting, making patient treatments more personalized, with the consequent reduction in pharmaceutical spending and lower costs for the Health System.
PHARMAGEN It is created with the mission of improving the quality of life of the population.
In the long term, the potential benefits of Pharmacogenomics point to reductions in the burden of disease, improvements in the efficiency of health systems and the reduction of discrepancies in access to health care, the consequence of all this is the reduction considerable in the health expenditure of the Public Health Services.
Objectives
The objective of FARMAGEN is to offer research centers, companies, hospitals and other professionals a specialized and personalized service. pharmacogenetic-pharmacogenomic analysis, which optimizes the effectiveness and safety of treatments, as well as the diagnosis and prevention of diseases, thus entering the field of Personalized medicine and offering high added value by reducing spending on Health Systems as a result of its application.
Services offered by the unit
The unit of PHARMAGEN offers the following services:
● Ad-hoc studies intended to provide personalized pharmacogenetics-pharmacogenomics services designed based on the client's needs (research projects, prospective or retrospective studies by gene, drug or pathology, clinical trials). In this case, it begins with a personalized advisory and consulting service where the client himself exposes his needs and FARMAGEN will study the viability of the proposed project and develop the design of the experiment (with specific Open Arrays according to the pathology, treatments, polymorphisms specific,…) prior to carrying it out. Response times in ad-hoc services are variable and will be negotiated with clients.
The demand that may arise in our Community will imply, if it is sufficient, the design of specific and appropriate Arrays for our community population.
The service consists of the following stages:
1. Prior Pharmacogenomic Advice.
2. Design of experiments.
3. Design of specific OpenArray (according to drugs, genetic variability, polymorphisms, etc.).
4. Reception of samples.
5. Development of the study design (DNA extraction. Determination of polymorphisms...etc).
6. Results report
7. Pharmacogenomic – Pharmacogenetic Advice
● Portfolio service is a Pharmacogenetic study of each patient or individual. Globally, a personalized Pharmacogenetic analysis can be carried out in relation to one or several drugs according to the patient's treatment, for this the necessary "arrays" are already designed and validated. Even so, the study design on the necessary polymorphisms will always be updated according to the recommendations of the FDA and EMA. Response times will be less than 10 business days from receipt of the sample.
The techniques used on which the services are based are
1. Analysis of individual polymorphisms
2. Complete microarray analysis (180-200 SNPs)
- Using QuantStudio 12K Real-Time PCR System with AccuFill OpenArray block, laptop and Sanger sequencing/INNOLIPA technology- Preventive genotyping of response to drugs (Psychotropic, Oncological, Cardiovascular, Immunological, etc.), transport proteins, receptors, etc.
2.1 OPEN ARRAY
2.2 Determination of SNPs + CNVs oriented to the area of psychiatry (specific)
The services have the following stages
1. Reception of samples. Traceability
2. DNA extraction and measurement of its purity
3. Preventive genotyping for drug response
4. Pharmacogenomic Study (Evaluation of biomarkers and polymorphisms)
5. Systematization of data
6. Results report
7. Pharmacogenomic-pharmacogenetic advice
Experimental Nanotoxicology and Immunotoxicology Unit (UNATI) IIS Aragón
Principal Investigator: Julián Pardo Jimeno
Responsible technician: Ariel Ramirez Labrada
Contact email: unati@iisaragon.es
La Nanotoxicology and Immunotoxicology Unit (UNATI) IIS Aragón offers companies, research centers and other professionals a specialized pharmacological and toxicological analysis service, personalized to their needs, that confirms the safety of their products, offering high added value and a very positive impact when it comes to its marketing.
The toxicological studies carried out will be based on the recommendations, regulations and protocols published by international agencies, specifically the protocols of the “Organization for Economic Co-operation and Development” (OECD).
UNATI It also extends its services, beyond nanomaterials, to any company and research group interested in increasing the quality of products for use in humans, whether of synthetic or natural origin, individualized or in their final formulation.
UNATI is created with the mission to increase the economic and social impact of companies and research centers that develop synthetic or natural products for use in humans, with a specialization in nanomaterials, but without forgetting any product for use in humans. Our vision is a specialized and personalized analysis service that favors the application and transfer of new developments to society, improving consumer confidence and increasing the commercial impact of products and companies.
Objectives and service portfolio:
The objective of UNATI is to offer companies and research centers a specialized and personalized service of complete toxicological analysis, which confirms the safety of its products, offering high added value and a very positive impact when it comes to marketing.The toxicological studies carried out will be based on the recommendations, regulations and protocols published by international agencies, specifically the protocols of the “Organization for Economic Co-operation and Development” (OECD).
We will offer a complete toxicological study in both in vitro and in vivo models (C. elegans, Mus musculus and Rattus norvegicus):
1. ACUTE TOXICITY.
2. SUBCHRONIC TOXICITY.
3. CHRONIC TOXICITY.
4. CYTOTOXICITY STUDIES IN CELL LINES.
5. GENOTOXICITY STUDIES.
6. IMMUNOTOXICITY STUDIES.
7. ENDOTOXIN TEST.
8. TOXICOLOGY STUDIES ON FERTILITY AND REPRODUCTION.
9. CARCINOGENIC POTENTIAL STUDIES.
10. STUDIES ON THE AFFECTION OF THE MICROBIAL FLORA.
11. DERMAL IRRITATION STUDIES.
12. STUDY OF DERMAL CORROSION.
13. AWARENESS STUDY.
14. STUDY OF EYE AND MUCOUS IRRITATION.
Preclinical Support Unit of Aragon (UAPA) IIS Aragon
What is the Preclinical Support Unit of Aragon?
The unit (PT23/00186 of the Aragon Health Research Institute / IISA) is a highly specialized service multidisciplinary, whose main objective is simulate in models preclinical the pathophysiological conditions of different tissues to try to better predict the responses of patients to different treatments. With this we try to accelerate and reduce the cost of the development of new therapeutic strategies that have a high impact on people's health.
The unit is responsible for providing a specialized service to research groups interested in using preclinical models based on:
- In vitro biomimetic models
- Animal models
- 3D printing-based models and surgical support
- Mathematical models based on simulation
Analytical Calorimetry Unit of Aragon (CLAUDIA) IIS Aragón
Principal Investigator: Olga Abian Franco – Adrián Velázquez Campoy
Responsible technician: Sonia Hermoso Durán
Contact email: claudia@iisaragon.es
La Analytical Calorimetry Unit of Aragon (CLAUDIA) of the IIS Aragón offers companies, research centers and other professionals, a specialized calorimetric analysis service of human and animal clinical samples for research purposes, and of biological and pharmaceutical products. We design a personalized protocol according to specific needs.
On the one hand, the calorimetric technique allows obtaining a real-time serum/plasma proteomic/metabolomic/interactomic profile with direct application in the diagnosis and monitoring of patients with different diseases or belonging to different study groups in clinical trials. Furthermore, it can be used as a personalized tool for evaluating the health status or potential metabolic alterations of each person over a specific period of time (pharmacological treatment, study groups in clinical trials of drugs or nutritional interventions, preclinical studies of drugs, etc.).
On the other hand, the calorimetric technique is used in the rapid evaluation of the structural and kinetic stability of biomacromolecules to determine optimal constructions of target molecules, estimate optimal conditions of formulation of protein-based biological products for therapeutic or diagnostic treatment, quantifying the useful life of protein-based biological products (e.g. therapeutic antibodies, nanobodies, proteins for molecular replacement therapy, etc.), and the validation of aspects related to biosimilarity (stability, conformation, aggregation) in biological products for treatment or diagnosis (e.g. proteins, lipid vesicles and liposomes, nanopolymers, etc.).
CLAUDIA provides companies and research groups with valuable information for the development and implementation of personalized patient monitoring protocols, and for the effective development of biological therapeutic and diagnostic treatment products. Patient diagnosis and monitoring procedures will benefit from a rapid and risk-free protocol to monitor health status; On the other hand, protein-based biological products in the development of which our services are used improve their quality and their expectations of success in a competitive globalized market.
Objectives
CLAUDIA offers companies and research groups/centers a specialized and personalized service for analyzing biological samples using calorimetry, offering high added value. The analyzes are performed in a dedicated and specialized laboratory with state-of-the-art automated equipment and strict monitoring of good laboratory practices, with personnel with proven experience in biological calorimetry for more than 25 years.
Services offered by the unit
The design of the workflow for each service offered from the unit is personalized for each client considering the specific and particular needs of each case study, taking into account the objectives, the timing of the service to be performed and the interest customer specific.
The CLAUDIA unit offers services:
1/ TLB studies: Oriented to the calorimetric analysis of serum/plasma of human/animal samples for research studies in the evaluation and monitoring of individuals in clinical studies.
2/ TDP studies: Oriented to the analysis of biotechnological products based on biomolecules (for example, drugs, vaccines and proteins for biotechnological application) both in the field of biotechnological development and basic research.
These services are specified in the products detailed below:
|
TLB_clinical |
Serum/plasma proteomic profile for evaluation and monitoring of patients undergoing treatment |
|
TLB_health |
Serum/plasma proteomic profile for evaluation and monitoring of participants in pharmacological safety and efficacy studies |
|
TLB_life |
Serum/plasma proteomic profile for evaluation and monitoring of participants in nutritional, psychological, occupational and activity-specific, and educational health studies |
|
TDP_design |
Evaluation and optimization of target molecule constructs (e.g. antibodies, nanobodies and proteins for molecular replacement therapy) |
|
TDP_formulation |
Determination of optimal formulation conditions for protein-based biological products for therapeutic or diagnostic treatment (e.g. therapeutic antibodies and nanobodies, aptamers, molecular replacement therapies, etc.) |
|
TDP_stability |
Quantification of structural stability and shelf life of protein-based biological products (e.g. therapeutic antibodies and nanobodies, aptamers, proteins for molecular replacement therapies, etc.) |
|
TDP_biosimilar |
Validation of structural aspects related to biosimilarity in biological products for treatment or diagnosis (e.g. proteins, lipid vesicles and liposomes, nanopolymers, etc.) |
The services may be accompanied by personalized technical advice if the client requests it and the products will be adapted to the needs in each case.
Scientific Technical Services
The Scientific Technical Services (SCT) They are facilities that integrate infrastructure and large equipment dedicated to the performing specialized techniques. They are staffed with highly qualified and permanently trained personnel, who guarantee their correct functioning and offer individualized technical and scientific advice and support.
The main objective of the SCT is to promote research in the biomedical area by making available to researchers scientific infrastructures that, due to their characteristics, generally exceed the possibilities of acquisition and use by individual research groups. and qualified personnel who offer specialized technical and scientific support.
The SCT are located in the Biomedical Research Center of Aragon and in the Faculty of Medicine of the University and are the result of the functional integration of different services in the field of biomedical research: the Transversal Research Support Units of the Institute Aragonese Department of Health Sciences (IACS) and the Biomedical Area of the General Research Support Service of the University of Zaragoza (UNIZAR). The SCTs are financed and managed by IACS and UNIZAR, institutions that offer them to the research community. Research projects managed through IACS, UNIZAR and Fundación IIS Aragón benefit from partially subsidized rates (internal rate).
1. SEQUENCING AND FUNCTIONAL GENOMICS
2. PROTEOMICS
3. CELL SEPARATION AND CYTOMETRY
4. CYTOMIC
5. CELL CULTURE
6. MICROBIOLOGICAL ANALYSIS
7. MICROSCOPY AND PATHOLOGICAL ANATOMY
8. ELECTRON MICROSCOPY OF BIOLOGICAL SYSTEMS
9. ANIMALARY
10. MEDICAL IMAGING AND PHENOTYPING
11.EXPERIMENTAL SURGERY
biobank
The Biobank of the Aragon Health System (BSSA), owned by the IACS, Its mission is to support biomedical research and accelerate translational research, promoting collaboration between professionals in the healthcare field. and basic researchers. Through the BSSA, the IACS makes human biological samples and clinical data available to the scientific community, with all ethical, legal and quality guarantees.
Methodological and Statistical Support Service
The IIS Aragón has the Methodological and Statistical Support Service (SAME) of the IACS. It is in charge of the Methodological Support Manager and its technical staff includes a specialist in Preventive Medicine and Public Health and a statistician. It also has the services of a pharmacist who is an expert in research ethics and a documentary filmmaker.
Its main objective is methodological support to research groups in the development of their projects.
Among its main functions are:
- Database design
- Debugging and quality criteria
- Statistical analysis, which includes: issuance of a previous report, meeting with the researcher, new analysis proposals, issuance of a new statistical report, completion of the work.
Virtual Library
The “Bibliosalud-Aragón” Virtual Library, managed and promoted by the IACS, is a space that offers access to the best resources and sources of information previously selected and organized so that access to information is easy and fast.
Access to the virtual library is free, but access to subscribed resources and services is restricted to researchers and staff who carry out their work in the public health system of Aragon.
All resources are accessible directly from the work computer (connected to the Government of Aragon network), without the need to enter passwords. To access remotely you must request the keys from the Virtual Library.