Nanbiosis

U22-S08. Dosing of test substances and non clinical specimen drawing in rodent and non-rodent species

Dosing of test substances and non clinical specimen drawing in rodent and non-rodent species

We provide a specialised and precise infraestructure to conduct preclinical studies that are crucial on the development of drugs and biological products. We employ advanced dosification techniques to accurately administer test substances to the study species, ensuring the correct application of the doses needed to assess the safety and efficacy of compounds under development.
Our team is highly trained in the collection of samples as blood, tissues and biological fluids, ensuring that high quality samples are obtained for subsequent analysis. This is essential to evaluate pharmacokinetics, pharmacodynamics and toxicity of the compounds under study.
In addition, we cover a wide-range of species, from rodents like mouse and rats to non-rodents like sheeps, pigs and rabbits. This allows for a more comprehensive evaluation of safety and efficacy of the compounds under development in different animal models.

Customer benefits

This service provides with rigurous certifications like ISO-9001 and Good Laboratory Practices, ensuring high quality standards for the production of precise results. This enables the performance of preclinical. Safety and efficacy studies in animal models in full compliance with regulatory guidelines, ensuring the reliability and traceability of all data generated.
In addition, the team is certified by the Spanish Agency of Medicines and Sanitary Products for a variety of studies, including substances dosing, biocompatibility, toxicity, tolerance and pharmacodynamics studies.

Target customer

• Pharmaceutical and Biotechnological Research Labs.
• Universities and Academic Institutions.
• Medical devices Companies.
• Governmental Regulatory Agencies.
• Research Centres from Hospitals.
• Animal feed and Nutrition Companies.
• Toxicological and Safety Labs.
• Cosmetics and Selfcare Companies.

Additional information

Selected references:

• Blázquez R, Sánchez-Margallo FM, Álvarez V, Matilla E, Hernández N, Marinaro F, Gómez-Serrano M, Jorge I, Casado JG, Macías-García B. Murine embryos exposed to human endometrial MSCs-derived extracellular vesicles exhibit higher VEGF/PDGF AA release, increased blastomere count and hatching rates. PLoS One. 2018 Apr 23;13(4):e0196080. 
• Marinaro F, Pericuesta E, Sánchez-Margallo FM, Casado JG, Álvarez V, Matilla E, Hernández N, Blázquez R, González-Fernández L, Gutiérrez-Adán A, Macías-García B. Extracellular vesicles derived from endometrial human mesenchymal stem cells improve IVF outcome in an aged murine model. Reprod Domest Anim. 2018 Sep;53 Suppl 2:46-49.

U22-S07. Development of animal models of disease in large animals

Development of animal models of disease in large animals

Our experimental centre offers a service for the development of animal models of disease in large animals, providing a specialized platform for the advance of biomedical research. We are dedicated on creating preclinical models that accurately mimic human diseases in animals like pigs and sheeps, with the goal of facilitating the study of complex diseases and the assessment of new therapies.
We work with researchers to design and develop animal models, tailored to their specific needs. From the selection of the right animal to the methodology of disease induction, we ensure to create relevant and reliable models.

Customer benefits

Our institution is certified by the Spanish Agency of Medicines and Sanitary Products for a wide variety variety of studies like “Dosage of problem substance and non clinical sampling“, “Biocompatibility studies of sanitary products“, “In vivo Toxicity“, “Tolerance“ and “Pharmacodinamycs“. In addition, we are certified with ISO-9001 and Good Laboratory Practices (BPL).

Target customer

The development of animal models of disease in large animals of our institution serves a wide variety of clients, including academic researchers, pharmaceutical and biotechnological companies, medical devices companies, other research centres, regulatory agencies, etc. These clients need relevant and reliable animal models to conduct research and preclinical evaluation.

Additional information

Selected publications:

• Blanco-Blázquez V, Báez-Díaz C, Sánchez-Margallo FM, Torrescusa A, Vela FJ, Abellán E, Crisóstomo V. Swine Models of Aneurysmal Diseases for Training and Research. J Vis Exp. 2022 Mar 23;(181).
• Sun F, Báez-Díaz C, Sánchez-Margallo FM. Canine prostate models in preclinical studies of minimally invasive interventions: part I, canine prostate anatomy and prostate cancer models. Transl Androl Urol. 2017 Jun;6(3):538-546.
• Usón Gargallo J, Sánchez Margallo FM, Díaz-Güemes Martín-Portugués I, Loscertales Martín de Agar B, Soria Gálvez F, Pascual Sánchez-Gijón S. Modelos experimentales en la cirugía laparoscópica urológica [Animal models in urological laparoscopic training]. Actas Urol Esp. 2006 May;30(5):443-50.

U22-S06. In vivo safety and efficacy studies of nanomaterials, biomaterials and new drugs in rodent and non-rodent species

In vivo safety and efficacy studies of nanomaterials, biomaterials and new drugs in rodent and non-rodent species

We offer a service to evaluate therapeutical potential and safety of these innovative materials and compounds on a preclinical environment. In terms of safety assessment, we carry out exhaustive studies to evaluate potential side effects of nanomaterials, biomaterials and new drugs on the body. This includes monitoring of clinical signs, hematological and biochemical parameters,as well as the histopathological evaluation of organs and tissues.
Our service also allows to evaluate therapeutic efficacy of nanomaterials, biomaterials and new drugs in animal models relevant to the disease or condition under study.
This can include the measuring of specific biomarkers, the evaluation of inmune response and the monitoring of disease progress.

Customer benefits

The team is certified by the Spanish Agency of Medicines and Sanitaty Products for a wide variety of studies like “Dosage of problem substance and non clinical sampling“, “Biocompatibility studies of sanitary products“, “In vivo Toxicity“, “Tolerance“ and “Pharmacodinamycs“. In addition, we are certified with ISO-9001 and Good Laboratory Practices (BPL). This allows to carry out preclinical, safety and efficacy studies in animal models, complying with regulations and ensuring the reliability and traceability of the results and tests performed.

Target customer

Pharmaceutical industries: Need to evaluate safety and efficacy of new drugs in animal models prior the clinical trials.
Biotechnology: It requires preclinical studies to demonstrate safety and efficacy of nanomaterials or medical biomaterials.
Medical devices: Seek to evaluate biocompatibility and efficacy of their products containing nanomaterials or biomaterials.
Regulatory Agencies: Require in vivo study data to evaluate safety and efficacy of these materials and drugs prior to its clinical approval.
In addition to the above, also clinical, preclinical and academic researchers.

Additional information

Selected publications:

• Durán-Rey D, Brito-Pereira R, Ribeiro C, Ribeiro S, Sánchez-Margallo JA, Crisóstomo V, Irastorza I, Silván U, Lanceros-Méndez S, Sánchez-Margallo FM. Development and evaluation of different electroactive poly(vinylidene fluoride) architectures for endothelial cell culture. Front Bioeng Biotechnol. 2022 Oct 19;10:1044667. 
• Gómez-Blanco JC, Galván-Chacón V, Patrocinio D, Matamoros M, Sánchez-Ortega ÁJ, Marcos AC, Duarte-León M, Marinaro F, Pagador JB, Sánchez-Margallo FM. Improving Cell Viability and Velocity in μ-Extrusion Bioprinting with a Novel Pre-Incubator Bioprinter and a Standard FDM 3D Printing Nozzle. Materials (Basel). 2021 Jun 5;14(11):3100.

U22-S05. In vivo PK/PD assays in rodent and non-rodent species

In vivo PK/PD assays in rodent and non-rodent species

Our PK/PD in vivo assay services, offers a wide range of Specialised resources and capabilities to meet our clients needs in the field of pharmaceutical development and biomedical research. Among the services we can offer are the following:
Customised Study design and Execution: We are committed to working closely with our clients to design study protocols tailored to their specific needs. Whether it is to evaluate the pharmacokinetics of a new compound or to understand its pharmacodynamic effect, we ensure that every study is tailored to its unique research objectives.
Our service covers a variety of tests and measurements to evaluate absorption, distribution, metabolism and excretion of compounds as well as their biological and pharmacological effect. This includes analysis of blood samples, tissues and other biological fluids, as well as biomarker assessments and physiological responses.
We count with modern facilities and up to date equipment to carry out PK/PD in vivo assays accurately and efficiently. Our technology allows us to obtain high quality data that are essential for decision-making in drug development

Customer benefits

We count with ISO-9001 and Good Laboratory Practices accreditations, which guarantee the accuracy of our results. This allows us to carry out preclinical research and safety and efficacy studies in rodent and non-rodent animal models, complying with regulatory standards and ensuring the reliability of our tests. Besides that, our team is authorised with the Spanish Agency of Medicines and Sanitary Products (AEMPS) to carry out a variety of studies, including substance dosing and pharmacodynamics, which supports the verification of efficacy, safety and biocompatibility.

Target customer

Any entity involved In the development, research or regulation of pharmaceuticals and therapeutics, could benefit from an in vivo PK/PD assay service. Such as, pharmaceuticals, clinical researchers, medical device companies, agrochemical companies, etc.

Additional information

Selected references:

• de Pedro MÁ, Gómez-Serrano M, Marinaro F, López E, Pulido M, Preußer C, Pogge von Strandmann E, Sánchez-Margallo FM, Álvarez V, Casado JG. IFN-Gamma and TNF-Alpha as a Priming Strategy to Enhance the Immunomodulatory Capacity of Secretomes from Menstrual Blood-Derived Stromal Cells. Int J Mol Sci. 2021 Nov 10;22(22):12177.
• Soria F, Morcillo E, Serrano A, Budia A, Fernández I, Fernández-Aparicio T, Sanchez-Margallo FM. Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model. Urology. 2018 May;115:59-64.
• Blázquez R, Sánchez-Margallo FM, Crisóstomo V, Báez C, Maestre J, García-Lindo M, Usón A, Álvarez V, Casado JG. Intrapericardial administration of mesenchymal stem cells in a large animal model: a bio-distribution analysis. PLoS One. 2015 Mar 27;10(3): 0122377.

U22-S04. In vivo biocompatibility studies of medical devices in rodent and non-rodent species

In vivo biocompatibility studies of medical devices in rodent and non-rodent species

We offer a service of in vivo biocompatibility studies of Medical devices, focused on evaluating safety and tolerability in rodent and non-rodent species. We can provide with tests that comply with rigorous regulatory standards, adapting to the needs of each device. Examples of tests include evaluation of skin irritation, subcutaneous implantation, localized toxicity studies, etc. We guarantee data integrity, working closely with researchers and manufacturers to continuously improve device performance.

Customer benefits

All facilities in our unit are certified according to ISO-9001 and Good Laboratory Practices (GLP), ensuring the accuracy of the results. This allows us to perform preclinical research and safety and efficacy studies in animal models according to regulatory criteria, guaranteeing the reliability of the tests performed. In addition, our team is authorized by the Spanish Agency of Medicines and Health Products (AEMPS) to carry out a variety of studies, from substance dosing to pharmacodynamics.

Target customer

• Medical Devices Companies.
• Biotechnology and Medical technology Companies.
• Pharmaceutical Companies.
• Academic Institutions and Research Centres,
• Consulting and Research Services Companies.
• Regulatory Agencies.
• Clinical Researchers.

Additional information

Selected references:

• Patrocinio D, Galván-Chacón V, Gómez-Blanco JC, Miguel SP, Loureiro J, Ribeiro MP, Coutinho P, Pagador JB, Sanchez-Margallo FM. Biopolymers for Tissue Engineering: Crosslinking, Printing Techniques, and Applications. Gels. 2023 Nov 10;9(11):890. 
• Marinaro F, Silva JM, Barros AA, Aroso IM, Gómez-Blanco JC, Jardin I, Lopez JJ, Pulido M, de Pedro MÁ, Reis RL, Sánchez-Margallo FM, Casado JG, López E. A Fibrin Coating Method of Polypropylene Meshes Enables the Adhesion of Menstrual Blood-Derived Mesenchymal Stromal Cells: A New Delivery Strategy for Stem Cell-Based Therapies. Int J Mol Sci. 2021 Dec 13;22(24):13385.
• Blázquez R, Sánchez-Margallo FM, Álvarez V, Usón A, Casado JG. Surgical meshes coated with mesenchymal stem cells provide an anti-inflammatory environment by a M2 macrophage polarization. Acta Biomater. 2016 Feb;31:221-230.

U22-S03. In vivo toxicology in rodent and non-rodent species

In vivo toxicology in rodent and non-rodent species

We offer a specialized service of in vivo Toxicology in both Rodent and Non-Rodent species to evaluate possible toxicological effects of chemical, pharmaceutical and biological compounds. Our veterinarians guarantee and ethical and safe environment, performing a wide variety of standard and customized tests, such as acute, subchronic, chronic, reproductive, developmental, toxicity and mutagenicity studies. We work according to rigorous ethical and regulatory standards to generate reliable data essential for risk assessment in product development.We work with researchers to design and develop animal models, tailored to their specific needs. From the selection of the right animal to the methodology of disease induction, we ensure to create relevant and reliable models.

Customer benefits

All areas and facilities integrated in the unit have obtained certifications according to ISO-9001 and Good Laboratory Practices (GLP) standards, guaranteeing the production of highly accurate results.
This allows us to carry out preclinical research and safety and efficacy studies in animal models in full compliance with the rigorous criteria established by regulatory agencies, ensuring the reliability and traceability of all results and tests performed in the different services that we offer.

Target customer

• Agrochemical companies.
• Food and beverage industry.
• Chemical manufacturers.
• Academic institutions.
• Regulatory agencies.
• Pharmaceutical industry.
• Any organization involved in the development, manufacture or products’ regulation with potential risks to human, animal or environmental health.

Additional information

Selected publications:

• Soria F, Delacruz JE, Aznar-Cervantes SD, Aranda J, Martínez-Pla L, Cepeda M, Pérez-Lanzac A, Bueno G, Sánchez-Margallo FM. Animal model assessment of a new design for a coated mitomycin-eluting biodegradable ureteral stent for intracavitary instillation as an adjuvant therapy in upper urothelial carcinoma. Minerva Urol Nephrol. 2023 Apr;75(2):194-202.
• Soria F, Morcillo E, López de Alda A, Pastor T, Sánchez-Margallo FM. Catéteres y stents urinarios biodegradables. ¿Para cuándo? [Biodegradable catheters and urinary stents. When?]. Arch Esp Urol. 2016 Oct;69(8):553-564.

U22-S02. In vivo experimental design/consultancy for preclinal studies

In vivo experimental design/consultancy for preclinal studies

Committed to excellence in preclinical research, we offer complete services on in vivo experimental design. We strive to facilitate the advancement of your research on an ethically and efficient way, wether in person or remotely. We work closely with researchers to maximise the quality of the data and minimize resource usage, always prioritizing animal welfare. Our facilities feature state of the art animal housing designed to ensure the comfort and safety of animals used in preclinical studies. Our services include guidance in animal model selection, personalized experimental design, ethical and regulatory supervision of in vivo procedures, and detailed data analysis to support result interpretation.

Customer benefits

Quality Certificate from AENOR (ER-0430/2002) according to UNE-EN-ISO 9001:2015.
Certificate of Compliance with Good Laboratory Practices (BPLI 23.05/001 AEMPS) to conduct studies in both human and veterinary medicine, including:

• In vivo toxicity.
• Tolerance.
• Pharmacodynamics.
• Administration of investigational product and collection of non-clinical specimens.
• Biocompatibility studies of medical devices.

We also have an associated Animal Care and Use Committee (Authorized body by the Government of Extremadura)

Target customer

• Academic researchers.
• Pharmaceutical and biotechnology companies.
• Medical research centres.
• Regulatory agencies and governmental organizations.
• Clinical researchers.

Additional information

Selected publications:

• Ballestín A, Casado JG, Abellán E, Vela FJ, Campos JL, Martínez-Chacón G, Bote J, Blázquez R, Sánchez-Margallo FM. A Pre-clinical Rat Model for the Study of Ischemia-reperfusion Injury in Reconstructive Microsurgery. J Vis Exp. 2019 Nov 8;(153).
• Blázquez R, Álvarez V, Antequera-Barroso JA, Báez-Díaz C, Blanco V, Maestre J, Moreno-Lobato B, López E, Marinaro F, Casado JG, Crisóstomo V, Sánchez-Margallo FM. Altered hematological, biochemical and immunological parameters as predictive biomarkers of severity in experimental myocardial infarction. Vet Immunol Immunopathol. 2018 Nov;205:49-57. 
• Sun F, Báez-Díaz C, Sánchez-Margallo FM. Canine prostate models in preclinical studies of minimally invasive interventions: part II, benign prostatic hyperplasia models. Transl Androl Urol. 2017 Jun;6(3):547-555.