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U23-S09. Quality control for Human Assisted Reproduction clinics

Quality control for Human Assisted Reproduction clinics

The assisted reproduction unit has a laboratory with extensive equipment with which to carry out the basic assisted reproduction techniques, among which are extraction of gametes (ovum and sperm), extraction of embryos, sperm analysis, vitrification and devitrification of gametes and embryos, in vitro fertilization (IVF) and ICSI. It also has a small animal surgery to perform surgery on small animals, mainly mice, which is the animal species with which we preferably work. To carry out these techniques, the Assisted Reproduction Unit is equipped with two intracytoplasmic micromanipulation equipment with IMSI, Laser and Oosight systems, embryo biopsy systems, and mitotic spindle vision systems. We also have a piezoelectric device to carry out ICSI with oocytes from different animal species. We have recently incorporated a Time Lapse incubator to evaluate embryonic development; we also have flow cabinets with stereomicroscopes and heaters, plates, incubators with different gas systems, freezing and cryopreservation equipment for gametes and embryos, among others.

Customer benefits

Because our laboratory is one of the few that does research in assisted reproduction with animal models and has all this equipment, in addition to a bank of gametes and cryopreserved embryos, human reproduction clinics that wish to carry out tests with culture methods for oocytes or embryos, they can only be done with animal species, so our laboratory is suitable for this. In addition, the studies can also be carried out under regulatory requirements, since the institution that carries them out is certified in Good Laboratory Practices.
In this way, preclinical studies can be carried out in animal models in compliance with the strict guidelines of the regulatory agencies, ensuring the reliability and traceability of all the results and tests carried out in its different services.

Target customer

This unit can provide services to all those companies that want to carry out quality control for Human Reproduction clinics, studies of in vitro fertilization and viability of embryo culture media, Micromanipulation and microinjection techniques of mouse embryos or other animal species, whether that we have piezo electric. Furthermore, as we have a bank of cryopreserved mouse oocytes and embryos, any company that needs to have a large number of these gametes and embryos can benefit from this service.

Additional information

  • Comparative pilot study of surgical activation vs application of platelet-rich plasma on ovarian function in an ovine animal model. P33. S Sánchez-Mateos, F Fabregues, E Párraga-Ros, I S Alvarez, J A Domínguez, M Méndez, J Ferreri, F M Sánchez Margallo.
    British Journal of Surgery, Volume 111, Issue Supplement_1, February 2024, znae018.033, https://doi.org/10.1093/bjs/znae018.033
  • Optimizations of an ovum pick up protocol in Donkey.
    Abstract publicado en la revista: Anim Reprod. 2022;19(2 spe):e22177
    https://www.animal-reproduction.org/journal/animreprod/article/62fe8d1fa9539502764c9db4
  • Supplementation of culture medium with quercetin improves mouse blastocyst quality and increases the expression of HIF-1α protein Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Zygote, 2023 Feb 27:1-12. https://doi:10.1017/S0967199423000060
  • Effect of the addition of 4OHE2 and quercetin in culture media on ROS levels and gene expression in mouse blastocysts
    Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Reproduction. Fertility and Development Sep;34(15):980-990
    https://doi.org/10.1071/RD22041
  • 4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro, and implantation rates. Hernández N, López-Morató M, Perianes MJ, Sánchez-Mateos S, Casas-Rua V, Domínguez-Arroyo JA, Sánchez-Margallo FM, Álvarez IS.
    Mol Hum Reprod. Vol 27 (2) 2021 Nov 25:gaaa075.
    https://doi.org/10.1093/molehr/gaaa075
  • Histological cut of a paraffin-embedded blastocyst: optimized protocol for murine blastocysts.
    Alejandra Uson; Marta López-Morató; José Mijares; Soledad Sánchez-Mateos; Francisco Sánchez- Margallo; Ignacio Álvarez; Nuria Hernández, MSc
    Methods X. vol 7, pp:1-9; 2020, 100767
    https://doi.org/10.1016/j.mex.2019.12.008
• Read More

U23-S07. Laser System and Biopsed of blastomeres

Laser System and Biopsed of blastomeres

In addition to having micromanipulation and microinjection equipment that allows us to inject sperm into the cytoplasmic cavity of the oocyte (ICSI). One of these microinjectors has a built-in laser system, which allows, by means of small shots, to make a small hole in the membrane of the embryo and, after absorption with specific needles for this process, obtain two or three cells of the trophectoderm and subsequently send these cells to specialized laboratories that perform preimplantation genetic diagnosis studies, to analyze possible abnormalities of the embryo before its transfer and implantation.

Customer benefits

Having these micromanipulation and microinjection equipment that incorporates a laser system to perform trophectoderm biopsy allows us to offer this service to embryologists who wish to train in this technique and acquire the necessary skills to be able to carry out this technique in the human clinic. Furthermore, the implementation of this ICSI technique and blastomere biopsy, and the handling and use of micromanipulators and microinjectors allows the practical training of master’s students and specialization courses in human or animal assisted reproduction.
Because our laboratory is one of the few that researches assisted reproduction with animal models and has all this equipment, human reproduction clinics that want to perform tests with animal oocytes or embryos can perform their tests.
In our laboratory, since experiments can only be carried out with animal species, our laboratory is suitable for this. In addition, the studies can also be carried out under regulatory requirements, since the institution that performs them is certified in Good Laboratory Practices.
In this way, preclinical studies can be carried out in animal models in compliance with the strict guidelines of the regulatory agencies, ensuring the reliability and traceability of all the results and tests carried out in its different services.

Target customer

This service can provide assistance to all those Human Reproduction companies and clinics that want to carry out in vitro fertilization studies using Micromanipulation and microinjection techniques of mouse embryos or other animal species, since we have a piezoelectric system that facilitates this process without damaging the oocyte In addition, they can perform a biopsy of the embryo’s blastomeres in order to later perform genetic studies on it.

Additional information

  • Comparative pilot study of surgical activation vs application of platelet-rich plasma on ovarian function in an ovine animal model. P33. S Sánchez-Mateos, F Fabregues, E Párraga-Ros, I S Alvarez, J A Domínguez, M Méndez, J Ferreri, F M Sánchez Margallo.
    British Journal of Surgery, Volume 111, Issue Supplement_1, February 2024, znae018.033, https://doi.org/10.1093/bjs/znae018.033
  • Optimizations of an ovum pick up protocol in Donkey.
    Abstract publicado en la revista: Anim Reprod. 2022;19(2 spe):e22177
    https://www.animal-reproduction.org/journal/animreprod/article/62fe8d1fa9539502764c9db4
  • Supplementation of culture medium with quercetin improves mouse blastocyst quality and increases the expression of HIF-1α protein Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Zygote, 2023 Feb 27:1-12. https://doi:10.1017/S0967199423000060
  • Effect of the addition of 4OHE2 and quercetin in culture media on ROS levels and gene expression in mouse blastocysts
    Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Reproduction. Fertility and Development Sep;34(15):980-990
    https://doi.org/10.1071/RD22041
  • 4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro, and implantation rates. Hernández N, López-Morató M, Perianes MJ, Sánchez-Mateos S, Casas-Rua V, Domínguez-Arroyo JA, Sánchez-Margallo FM, Álvarez IS.
    Mol Hum Reprod. Vol 27 (2) 2021 Nov 25:gaaa075.
    https://doi.org/10.1093/molehr/gaaa075
  • Histological cut of a paraffin-embedded blastocyst: optimized protocol for murine blastocysts.
    Alejandra Uson; Marta López-Morató; José Mijares; Soledad Sánchez-Mateos; Francisco Sánchez- Margallo; Ignacio Álvarez; Nuria Hernández, MSc
    Methods X. vol 7, pp:1-9; 2020, 100767
    https://doi.org/10.1016/j.mex.2019.12.008
• Read More

U23-S06. IMSI System

IMSI System

Within the Assisted Reproduction Unit we have a laboratory equipped with two micromanipulation and microinjection equipment that allows us to inject the sperm into the cytoplasmic cavity of the oocyte (ICSI), in order to carry out fertilization. The advantage that this equipment offers is that it allows us to perform in vitro fertilization without having to have a large number of sperm and oocytes. Furthermore, to be able to perform this technique with oocytes from different animal species, we have a piezoelectric device to perform this intracytoplasmic injection without damaging the oocyte of the specific animal species. Another possibility offered by this service is that in one of these microscopes we have a 6000x objective, which allows us to see the sperm in large sizes. In this way we can select the sperm that are morphologically of the best quality for intracytoplasmic injection (IMSI), which will subsequently allow us to obtain better quality embryos.

Customer benefits

Having these micromanipulation and microinjection equipment allows us to offer this service to embryologists who wish to train in this technique and acquire the necessary skills to be able to carry out this technique in the human clinic. In addition, the implementation of this ICSI and IMSI technique and the handling and use of micromanipulators and microinjectors allows for practical training for master’s students and specialized courses in human or animal assisted reproduction.
Because our laboratory is one of the few that researches assisted reproduction with animal models and has all this equipment, human reproduction clinics that want to perform tests with animal oocytes or embryos can perform their tests.
In our laboratory, since experiments can only be carried out with animal species, so our laboratory is suitable for it. In addition, the studies can also be carried out under regulatory requirements, since the institution that performs them is certified in Good Laboratory Practices.
In this way, preclinical studies can be carried out in animal models in compliance with the strict guidelines of the regulatory agencies, ensuring the reliability and traceability of all the results and tests carried out in its different services.

Target customer

This service can provide assistance to all those Human Reproduction companies and clinics that want to carry out in vitro fertilization studies using Micromanipulation and microinjection techniques of mouse embryos or other animal species, since we have a piezoelectric system that facilitates this process without damaging the oocyte.

Additional information

  • Comparative pilot study of surgical activation vs application of platelet-rich plasma on ovarian function in an ovine animal model. P33. S Sánchez-Mateos, F Fabregues, E Párraga-Ros, I S Alvarez, J A Domínguez, M Méndez, J Ferreri, F M Sánchez Margallo.
    British Journal of Surgery, Volume 111, Issue Supplement_1, February 2024, znae018.033, https://doi.org/10.1093/bjs/znae018.033
  • Optimizations of an ovum pick up protocol in Donkey.
    Abstract publicado en la revista: Anim Reprod. 2022;19(2 spe):e22177
    https://www.animal-reproduction.org/journal/animreprod/article/62fe8d1fa9539502764c9db4
  • Supplementation of culture medium with quercetin improves mouse blastocyst quality and increases the expression of HIF-1α protein Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Zygote, 2023 Feb 27:1-12. https://doi:10.1017/S0967199423000060
  • Effect of the addition of 4OHE2 and quercetin in culture media on ROS levels and gene expression in mouse blastocysts
    Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Reproduction. Fertility and Development Sep;34(15):980-990
    https://doi.org/10.1071/RD22041
  • 4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro, and implantation rates. Hernández N, López-Morató M, Perianes MJ, Sánchez-Mateos S, Casas-Rua V, Domínguez-Arroyo JA, Sánchez-Margallo FM, Álvarez IS.
    Mol Hum Reprod. Vol 27 (2) 2021 Nov 25:gaaa075.
    https://doi.org/10.1093/molehr/gaaa075
  • Histological cut of a paraffin-embedded blastocyst: optimized protocol for murine blastocysts.
    Alejandra Uson; Marta López-Morató; José Mijares; Soledad Sánchez-Mateos; Francisco Sánchez- Margallo; Ignacio Álvarez; Nuria Hernández, MSc
    Methods X. vol 7, pp:1-9; 2020, 100767
    https://doi.org/10.1016/j.mex.2019.12.008
• Read More

U23-S05. In vitro maturation

In vitro maturation

In the assisted reproduction unit we work with experimental animal models, mainly mice, in which we usually extract gametes and embryos, in which we evaluate the maturation process and viability of these oocytes, through tests with different culture media and with enrichment of these culture media with different compounds, to observe which of them produces the best degree of maturation, development and viability of the same, not only of oocytes but also of follicles from other animal species such as sheep. This development and duration can be observed directly using the time-lapse incubator and with different viability tests that are carried out later.

Customer benefits

Because our laboratory is one of the few that does research in assisted reproduction with animal models and has all this equipment, in addition to a bank of gametes and cryopreserved embryos, human reproduction clinics that wish to carry out tests with culture methods for oocytes or embryos, they can only be done with animal species, so our laboratory is suitable for this. In addition, the studies can also be carried out under regulatory requirements, since the institution that carries them out is certified in Good Laboratory Practices.
In this way, preclinical studies can be carried out in animal models in compliance with the strict guidelines of the regulatory agencies, ensuring the reliability and traceability of all the results and tests carried out in its different services.

Target customer

This unit can provide services to all those companies that want to carry out studies of in vitro fertilization and viability of embryonic culture media for mouse embryos or other animal species, and the development and degree of maturation of oocytes and follicles after the addition of different compounds. to these culture media. Furthermore, by having a bank of cryopreserved mouse oocytes and embryos, any company that needs to have a large number of these gametes and embryos can benefit from this service.

Additional information

  • Comparative pilot study of surgical activation vs application of platelet-rich plasma on ovarian function in an ovine animal model. P33. S Sánchez-Mateos, F Fabregues, E Párraga-Ros, I S Alvarez, J A Domínguez, M Méndez, J Ferreri, F M Sánchez Margallo.
    British Journal of Surgery, Volume 111, Issue Supplement_1, February 2024, znae018.033, https://doi.org/10.1093/bjs/znae018.033
  • Optimizations of an ovum pick up protocol in Donkey.
    Abstract publicado en la revista: Anim Reprod. 2022;19(2 spe):e22177
    https://www.animal-reproduction.org/journal/animreprod/article/62fe8d1fa9539502764c9db4
  • Supplementation of culture medium with quercetin improves mouse blastocyst quality and increases the expression of HIF-1α protein Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Zygote, 2023 Feb 27:1-12. https://doi:10.1017/S0967199423000060
  • Effect of the addition of 4OHE2 and quercetin in culture media on ROS levels and gene expression in mouse blastocysts
    Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Reproduction. Fertility and Development Sep;34(15):980-990
    https://doi.org/10.1071/RD22041
  • 4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro, and implantation rates. Hernández N, López-Morató M, Perianes MJ, Sánchez-Mateos S, Casas-Rua V, Domínguez-Arroyo JA, Sánchez-Margallo FM, Álvarez IS.
    Mol Hum Reprod. Vol 27 (2) 2021 Nov 25:gaaa075.
    https://doi.org/10.1093/molehr/gaaa075
  • Histological cut of a paraffin-embedded blastocyst: optimized protocol for murine blastocysts.
    Alejandra Uson; Marta López-Morató; José Mijares; Soledad Sánchez-Mateos; Francisco Sánchez- Margallo; Ignacio Álvarez; Nuria Hernández, MSc
    Methods X. vol 7, pp:1-9; 2020, 100767
    https://doi.org/10.1016/j.mex.2019.12.008
• Read More

U23-S04. Sperm, oocyte and embryo cryopreservation

Sperm, oocyte and embryo cryopreservation

The assisted reproduction unit has a laboratory with extensive equipment with which to perform basic assisted reproduction techniques, including the extraction of gametes (egg and sperm), the extraction of embryos, the analysis of sperm, the vitrification and devitrification of gametes and embryos obtained by in vitro fertilization, IVF and ICSI. Because we work mainly with a murine animal model, obtaining gametes, both oocytes and spermatozoa, is easy and allows us to obtain a large number of gametes, since we have this animal species in the animal facility service of the centre itself, making it easy to access, to this animal model, as well as the large number of gametes that we obtain allows us to create a germplasm biobank, in addition to embryos, which we vitrify and cryopreserve and that can be used and requested by companies for their studies.

Customer benefits

Because our laboratory is one of the few that does research in assisted reproduction with animal models and has all this equipment, in addition to a bank of gametes and cryopreserved embryos, human reproduction clinics that wish to carry out tests with culture methods for oocytes or embryos, they can only be done with animal species, so our laboratory is suitable for this. In addition, the studies can also be carried out under regulatory requirements, since the institution that carries them out is certified in Good Laboratory Practices.
In this way, preclinical studies can be carried out in animal models in compliance with the strict guidelines of the regulatory agencies, ensuring the reliability and traceability of all the results and tests carried out in its different services.

Target customer

This unit can provide services to all those companies that want to carry out studies of in vitro fertilization and viability of embryo culture media. Furthermore, as we have a bank of cryopreserved mouse oocytes and embryos, any company that needs to have a large number of these gametes and embryos can benefit from this service.

Additional information

  • Comparative pilot study of surgical activation vs application of platelet-rich plasma on ovarian function in an ovine animal model. P33. S Sánchez-Mateos, F Fabregues, E Párraga-Ros, I S Alvarez, J A Domínguez, M Méndez, J Ferreri, F M Sánchez Margallo.
    British Journal of Surgery, Volume 111, Issue Supplement_1, February 2024, znae018.033, https://doi.org/10.1093/bjs/znae018.033
  • Optimizations of an ovum pick up protocol in Donkey.
    Abstract publicado en la revista: Anim Reprod. 2022;19(2 spe):e22177
    https://www.animal-reproduction.org/journal/animreprod/article/62fe8d1fa9539502764c9db4
  • Supplementation of culture medium with quercetin improves mouse blastocyst quality and increases the expression of HIF-1α protein Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Zygote, 2023 Feb 27:1-12. https://doi:10.1017/S0967199423000060
  • Effect of the addition of 4OHE2 and quercetin in culture media on ROS levels and gene expression in mouse blastocysts
    Hernández, Nuria; Sánchez-Mateos, Soledad; López-Morató, Marta; Sánchez-Margallo, Francisco; Álvarez, Ignacio.
    Reproduction. Fertility and Development Sep;34(15):980-990
    https://doi.org/10.1071/RD22041
  • 4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro, and implantation rates. Hernández N, López-Morató M, Perianes MJ, Sánchez-Mateos S, Casas-Rua V, Domínguez-Arroyo JA, Sánchez-Margallo FM, Álvarez IS.
    Mol Hum Reprod. Vol 27 (2) 2021 Nov 25:gaaa075.
    https://doi.org/10.1093/molehr/gaaa075
  • Histological cut of a paraffin-embedded blastocyst: optimized protocol for murine blastocysts.
    Alejandra Uson; Marta López-Morató; José Mijares; Soledad Sánchez-Mateos; Francisco Sánchez- Margallo; Ignacio Álvarez; Nuria Hernández, MSc
    Methods X. vol 7, pp:1-9; 2020, 100767
    https://doi.org/10.1016/j.mex.2019.12.008
• Read More

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.
• Read More

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.
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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.
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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.

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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.
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