Research

CMCiB is a 4500 m2 one-stop shop dedicated to supporting early-stage research and advanced acute or chronic studies with a great variety of models, including clinical-stage studies requiring MRI image acquisition and processing. Its well-equipped advanced surgical facility and newly-built additional operating theatres offer multiple possibilities for medtech and medical companies to undergo medical device validation studies and perform advanced surgical training for healthcare professionals.

Your Project at CMCiB

CMCiB offers a broad range of services within its SPF biocontainment, Biosafety level 3 (BSL-3), and surgical area facilities, complemented by advanced bioimaging technologies to support preclinical research and clinical research studies requiring Magnetic Ressonance Imaging (MRI). The newly created Computational Analysis Unit can also offer bioimaging data processing services.

The centre is equipped to host multiple model types and alternative models, tailored to the specific needs, types of studies, and research objectives of all clients. CMCiB holds all main certifications and is fully accredited by the competent authorities for conducting preclinical research with various species. All studies are performed adhering to stringent good practice and quality standards.

CMCiB is fully committed to animal care and welfare, ensuring the 3R principles are upheld in all activities, with prior authorization from the CMCiB Ethics Committee and the governmental authority in line with Directive 2010/63/EU.

The state-of-the-art surgical facilities are equipped for conducting Medical Device Validation Good Laboratory Practice (GLP) studies requiring large animal models, utilising advanced bioimaging technologies such as Vascular Interventional Radiology and Magnetic Resonance Imaging (3T). These facilities also comply with other International Quality Standards (ISO 10993-2:2006, ISO 10993-6, and ISO 10993-4).

CMCiB adheres to the Good Laboratory Practice Principles set out by Royal Decree 822/1993, in the performance of non-clinical studies with medical devices: Analytical and clinical chemistry testing (8*) and Other studies (9*), in accordance with OECD Decision C(89)87.

Services for studies involving medical devices include designing study guides based on the client's study protocol, conducting experimental studies in the  accredited large model surgical facilities with standard operating procedures, calibrated equipment, and skilled personnel. This also encompasses data recording and the preparation of formal study reports intended to support regulatory submissions of the product to regulatory bodies.

CMCiB is staffed by a dedicated team of multidisciplinary experts in laboratory animal science, biosafety, surgery, and bioimaging. CMCiB's mission is to assist clients in designing unique research strategies and achieving successful outcomes for their projects.

What we offer

CMCiB offers state-of-the art facilities for preclinical research studies under Biocontainment and Biosafety Level 3 (BSL-3) conditions with small animal models (rodents) and alternative models such as Drosophila Melanogaster, as well as in-vitro and in-silico models. Activities requiring large animals (swine and ovine) or cadaver models can be performed in the advanced surgical facility, in combination with bioimaging tecnologies. The biocontainment, BSL-3 and surgical areas have hosted and helped develop or validate more than 60 disease models and 20 surgical techniques, whereas the Bioimaging Unit has welcomed more than 300 human volunteers that have participated in MRI studies.

Besides research studies, its privileged location at Can Ruti Campus, about 30 km from El Prat Barcelona Airport, and its well-equipped, versatile and modular operating theatres offer multiple opportunities for medical companies seeking a high-quality facility to conduct specialized trainings for healthcare professionals.

Biocontainment and BSL-3 facilities

CMCiB's infrastructure is equipped with two distinct biocontainment areas: 1) conventional/Specific-Pathogen-free (SPF) facilities and 2) Biosafety level-3 housing and laboratories. Service areas have been designed with built-in sterilization equipment at entry points. The integrated organizational designs allows carrying out research and service activities simultaneously and independently, with domotic systems in place to control conditions and processes.

The biocontainment area offers the possibility of working with humanized models (Caessium irradiator available in-house) and develop research projects in therapeutic areas related to genetic diseases, immunology, oncology and gene therapies, in SPF conditions.

  • Models: small rodents (mice, hamster, rat) and rabbit.
  • Experience with multiple mice models in various therapeutic areas: breast cancer, lung cancer, ovarian cancer, colon cancer, melanoma, multiple sclerosis, diabetes type I, Rett Syndrome,...

Services:

  • Breeding area only available for transgenic mice.
  • Experimental studies with immunodepressed and humanized small rodents and Genetically Modified Organisms (GMO's)
  • Transgenic colony management
  • Humanization of mice with human cells of patients & healthy controls
  • Inoculation of substances, drugs, reagents, etc. through various administration modes: oral, subcutaneous, intraperitoneal, intradermal, intramuscular, intratibial, intravenous, intraocular, intravaginal, orthotopic (direct to the organ, tumor, etc.)
  • Extraction of blood and cerebrospinal fluid
  • Organ perfusion with PBS and Formaldehyde
  • C- section (mice)
  • Embryo transfer
  • Biopsy: ears and tail for genotyping, intracardiac blood (endpoint) or maxillofacial vein (submandibular), saphenous vein, jugular vein (rat, hamster)
  • Generation PDX (Patient-Derived Xenograft) tumors
  • Necropsy and organ extraction: blood, pancreas, liver, kidney, heart, lung, timus, thyroid, leg muscles, gastrocnemius, brain, spinal bulb, bone marrow
  • Ear marking, microchips, tattooing

The BSL-3 area allows for the development of research projects requiring infectious agents, for the development of vaccines and multidrug-resistant agents, among others. Facilities comprise 3 in-vitro laboratories, 4 animal laboratories and 2 imaging labs, with in-vivo imaging techniques (fluorescence and bioluminescence, LI-COR) and a super-resolution confocal microscope (Abberior Infinity).

A Middlebrook Aerosol generation apparatus with capacity for 120 mice is also available to generate respiratory disease animal models. CMCiB's has a track-record in research and development of studies with infectious agents such as HIV, SARS-CoV-2, tuberculosis, monkeypox, syphilis and respiratory syncytial virus (RSV), among others.

  • Models. In-vitro: cellular cultures & organoids; In-vivo: Drosophila Melanogaster fly, small rodents
  • Experience in multiple models with various diseases: Drosophila models (M. Tuberculosis), organoids (SARS-CoV-2), respiratory models (M. Tuberculosis, SARS-CoV-2, RSV), HIV models with humanized mice, Rabies Mouse model, Lymphocyte Choriomeningitis Virus (LCV) Mouse model, Resistant bacterial strains mouse models, RSV Cotton Rat model

Services:

  • Processing of biological samples:
  • Cell cultures
  • Animal Tissues (Tissuelyser Technology)
  • Extractions of Genetic Material by PCR
  • Bacterial cultures (M. tuberculosis, E. coli, N gonorrheae, etc.)
  • Preparation and inactivation of samples
  • Sample preparation for transcriptomics studies
  • Intranasal, endovenous and aerosolization infections
  • Vaccine efficacy models and drug potency studies

Advanced Surgical Area

Activities in the advanced surgical area play a significant role at CMCiB. The veterinarians and technicians of the surgical area provide support to complex biomedical research projects requiring large animals (pig and sheep) or alternative models in many therapeutic areas, from testing of new technologies and surgical techniques, therapies or drug products to medical device validation.

The facilities offer housing and pens for swine and sheep models and well-equipped operating theatres, customisable to each study and client's needs. The housing capabilities allow for acute and long-term chronic studies while guaranteeing animal control, care and welfare. Added to the possibility of including complex bioimaging techniques, these features make CMCiB a unique facility for conducting complex preclinical research.

The surgical area counts with 8 surgical operating rooms (4 new ORs in a modular room, dedicated to training, and 4 modular experimental ORs: 3 x 35 m2 modular ORs and 1 x 35 m2 X-ray OR, which features ORs feature broadcasting capabilities with the multi-purpose training room on the main floor and lounge area, with capacity for 50 people). The experimental operating theatres can feature up to 10 surgical stations and contain all basic surgical material as well as specific equipment and imaging tecnologies (ultrasound, endoscopy, laparoscopy, ...).

CMCiB's research track-record comprises multiple complex procedures, techniques and models in cardiovascular and respiratory diseases, CNS, nephrology, ophthalmology, digestive and endocrine system diseases, among others (non-exhaustive list):

  • Brain stroke model
  • Rette mirabile embolization
  • Interventionist thrombectomy
  • Myocardial infarction
  • Epicardia ablation model
  • Cardiac mapping
  • Validation of medical devices (endovascular, protheses, implants, stents, muscular electrostimulation devices, tendon and articular regeneration models, etc.)
  • Chronic Renal disease model
  • Renal embolization/transplant model
  • Glaucoma model

The facilities also feature a Cath lab OR with a Canon Medical Alphenix Core+ Vascular Interventional Radiology (VIR) angiograph and they are supported by imaging technologies such as 3T MRI (Canon Medical), which are often used in the validation of medical devices, and are certified for conducting GLP studies.

CMCiB Surgical Facility and Operating Room tour

Medical device validation and GLP studies

Good Laboratory Practices (GLP) are the highest quality standard that CMCiB offers to its clients in the pharmaceutical and medtech (medical devices) sectors, ensuring that data obtained during product validation trials are reliable, reproducible, and auditable, following international criteria recognised by regulatory agencies. The reaccreditation in 2023* and obtaining the GLP compliance certificate for the surgical area underscore the trajectory and quality of CMCiB's services for medical device validation and the goal of achieving excellence in research and translating results into clinical practice.

Since the centre's inception, the surgical team has been involved in development and functional validation projects for a wide range of medical devices in various therapeutic areas and for different indications, such as prostheses, catheters, valves, stents, embolizing fluids, biodegradable implants, etc., which have been fundamental in achieving the experience and establishing the quality and demanding system required for GLP certification.

CMCiB has participated in the GLP Validation Studies of vascular embolizing products from iVascular and Rob Surgical's Bitrack Robot.

*CMCiB facilities renewed its certificate of compliance with Good Laboratory Practices (GLP) in accordance with Directive 2004/9/EC in October 2023.

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Bioimaging

One of CMCiB's main objectives is to contribute to the fulfilment of all 3R principles through the use of complex bioimaging technologies, working closely with equipment suppliers and partners to apply the latest developments and add value to preclinical research in various therapeutic areas.

In addition to image acquisition, the Bioimaging Unit offers image processing services in neuroimaging, cardiology and semi-automated whole-body segmentation for radiomics and artificial intelligence studies.

The future of bioimaging at CMCiB is to meet the most advanced biomedical research needs, always facilitating the transferability of results to improve human health while minimising the use of animals.

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The Animal Experimentation Ethics Committee CEEA

All work at the CMCiB must comply with current Spanish and European legislation regulating ethical research and animal welfare. To ensure this, in July 2018 the Animal Experimentation Ethics Committee (CEEA) of the Comparative Medicine and Bioimage Centre of Catalonia (CEEA-CMCiB) of the IGTP was set up to ensure a rapid, transparent approval of proposed experiments according to international standards and an effective monitoring body.

Functions:

  • Checking and approval of all research project proposals ensuring that the appropriateness of the procedure in relation to the objectives of the study, the relevant conclusions can be reached with the smallest number of animals and that the effect on the animals is not disproportional in relation to the potential benefits of the research
  • Acting as an intermediate between the Government of the Catalonia and the researchers who will carry out the research
  • Quantifying and reporting on the functioning of the centre regarding animal welfare, veterinary reports, periodic checks carried out by the committee and acting on comments received from users of the centre
  • Reporting on the state of the centre's facilities for animal housing and research and revision of reports for the Management of the institute (IGTP)

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Legal Framework

Work at the CMCiB complies with the following Spanish and European laws:

  • Law 5/1995, 21 June, Protection of Animals used in Scientific Experiments
  • Decree 214/1997, 30 July, Regulation of use of animals for Scientific Experiments
  • Royal Decree 1201/2005, 10 de octuber, for the protection of animals used in experiments and for other scientific purposes.
  • European Parliament Directive 2010/63/EU and Council of 22 September 2010 regarding protection of animals used for scientific purposes
  • Royal Decree 53/2013 1 February establishing basic rules applicable to the protection of animals used in experiments and for other scientific purposes including teaching
  • Law 6/2013, 11 June modifying Law 32/2007, 7 November for the care, use, transport, experimentation and euthanasia of animals

Transparency

The IGTP has set up the CMCiB to carry out essential biomedical research to improve healthcare and quality of life of citizens while fully following a 3R policy to: reduce the number of animals used, refine techniques to maximize welfare and where possible to replace animal subjects.

In line with this objective the Germans Trias i Pujol Research Institute (IGTP) has joined the agreement on Openness on Animal Research, promoted from the Federation of Scientific Societies in Spain (COSCE), with the collaboration of the European Association of Research Animals (EARA) launched on 20 September 2016.

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