Singular

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.