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NANBIOSIS in the new poster of ICTS map published by Spanish Goverment.

ICTS underpins the Spanish reputation for research excellence.

In the picture: the new poster of the ICTS map in which NANBIOSIS facilities have been highlighed

The term Unique Scientific and Technical Infrastructure (ICTS) refers to facilities, resources, or services for the development of top-quality cutting-edge research, as well as the communication, exchange, and preservation of knowledge, the transfer of technology, and promotion of innovation. They are unique or exceptional in their fields, with a high cost of investment, maintenance, and operation, and are of a strategic importance that justifies their availability to all actors in the field of R&D&I. The ICTS share three fundamental characteristics; they are infrastructures with public ownership, unique and open to competitive access.

ICTS offer an opening capacity percentage of their essential services under ‘Competitive Open Access’ for the use by national and international public and private sector researchers, with the support of technical and administrative personnel of the ICTS. Infrastructures access is ruled by a public “Access Protocol” that describes the procedure and criteria for access to the infrastructure. The main features of ‘Competitive Open Access’ are that R + D + i quality of activities developed at the infrastructure should be proven and that requests for access should be prioritized on the basis of objective criteria.

The dissemination of ICTS and their capabilities is essential to provide Spanish and international researchers with access to a large base of quality services and facilities, a basic requirement for the development of excellent science.

The new posster pushised by the General Subdirectorate of Large
Scientific-Technical Facilities of the of the Sapanish Ministry of Science and Research Innovation helps to disseminate and understand the map of ICTS wich are located throughout the country

NANBIOSIS, is one of the five ICTS in the field of Health Sciences and Biotecnology

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Fabry Desease in the Rare Disease Day: A New Hope

WHY DO CELEBRATE TODAY THE INTERNATIONAL #RareDiseaseDay?

29 of February is a ‘rare’ date and February, a month with a ‘rare’ number of days, has become a month to raise awareness about rare diseases and their impact on patients’ lives.  Since 2008 thousands of events happen every year all around the world and around the last day of February with the aim of improving equity and reducing stigmatization for people who live with more than 6,000 rare diseases.

WHAT ARE RARE DISEASES

Rare diseases are pathologies or disorders that affect a small part of the population (less than 5 per 10,000 inhabitants) and generally have a genetic component. They are also known as orphan diseases.

Diseases present a series of particular symptoms, and it is very difficult to diagnose what their true cause is. These disorders or alterations that patients present must be evaluated by a specialist, depending on each case.

Today 5% of the world population suffer from them. This translated into numbers, corresponds to approximately 300 million affected.

A patient with a rare disease waits an average of 4 years to obtain a diagnosis, in 20% of cases it takes 10 or more years to achieve the proper diagnosis.

ORPHAN DRUGS

To combat this disease, patients need to be treated with so-called orphan drugs. They serve to prevent and treat pathology. Its composition is based on biotechnological compounds whose manufacture is very expensive and not profitable for companies. For this reason, cooperation of governments is needed as well as financial incentives to encourage pharmaceutical companies to develop and market medicines to make these treatments accessible to a greater number of people.

FABRY DISEASE

Fabry is one of the rare diseases that currently lack a definitive cure. Symptoms may include episodes of pain, especially in the hands and feet (acroparesthesias); small dark red spots on the skin called angiokeratomas; decreased secretion of sweat (hypohidrosis); opacity of the cornea (cataracts) and hearing loss. Internal organs such as the kidney, heart, or brain may be involved, resulting in progressive kidney damage, heart attacks, and strokes.

Fabry disease is a lysosomal storage disease arising from a deficiency of the enzyme α-galactosidase A (GLA). The enzyme deficiency results in an accumulation of glycolipids, which over time, leads to cardiovascular, cerebrovascular, and renal disease, ultimately leading to death in the fourth or fifth decade of life. Currently, lysosomal storage disorders are treated by enzyme replacement therapy (ERT) through the direct administration of the missing enzyme to the patients.

SMART 4 FABRY” EUROPEAN PROJECT

CIBER-BBN, through the researcher Nora Ventosa has coordinated the european project “Smart-4-Fabry” developed during 2017-2021, the proyect was undertaken by a consortium formed by ten partners, including private companies and public institutions in Europe and Israel, with a Horizon 2020 financial programme by the European Commission (H2020-NMBP-2016-2017; call for nanotechnologies, advanced materials, biotechnology and production; Proposal number: 720942-2).

In view of their advantages as drug delivery systems, liposomes are increasingly being researched and utilized in the pharmaceutical, food and cosmetic industries, but one of the main barriers to market is their scalability.

Depressurization of an Expanded Liquid Organic Solution into aqueous solution (DELOS-susp) is a compressed fluid-based method that allows the reproducible and scalable production of nanovesicular systems with remarkable physicochemical characteristics, in terms of homogeneity, morphology, and particle size. The objective of this work was to optimize and reach a suitable formulation for in vivo preclinical studies by implementing a Quality by Design (QbD) approach, a methodology recommended by the FDA and the EMA to develop robust drug manufacturing and control methods, to the preparation of α-galactosidase-loaded nanoliposomes (nanoGLA) for the treatment of Fabry disease.

Through a risk analysis and a Design of Experiments (DoE), researechers obtained the Design Space in which GLA concentration and lipid concentration were found as critical parameters for achieving a stable nanoformulation. This Design Space allowed the optimization of the process to produce a nanoformulation suitable for in vivo preclinical testing.

The new nanoformulation developed by Smart4Fabry for the treatment of Fabry disease achieved the ODD (Orphan Drug Designation) by the European Commission. The new nanomedicine is more effective and has a better biodistribution than the current treatments, based on enzyme replacement. The new nanomedicine is based on a nanovesicle that protects the enzyme and achieves a better cell internalisation, thus reducing the doses needed, the total cost and improving the quality of patients.

Four units of NANBIOSIS participated in the project:

– U1 Protein Production Platform (PPP) led by Neus Ferrer and Antony Villaverde at IBB-UAB for the production and purification in different expression systems for R&D purposes.

– U3 Synthesis of Peptides Unit led by Miriam Royo at IQAC-CSIC performed all the chemical process of the Smart-4-Fabry project, i.e. design and synthesis of peptides used as targeting ligands in the nanoliposome formulation.

– U6 Biomaterial Processing and Nanostructuring Unit led by Nora Ventosa at ICMAB-CSIC developed tasks related to the manufacture of the nanoliposome formulation of GLA enzyme and the physico-chemical characterization (this unit counts with plants at different scales, from mL to L, which allow process development by QbD and process scale-up, as well as instrumental techniques for assessment of particle size distribution, particle concentration, particle morphology and stability, and Z-potential) .

– U20 In Vivo Experimental Platform led by Ibane Abásolo at VHIR carried out the non-GLP preclinical assays of the project (in vivo efficacy, biodistribution and tolerance/toxicity assays).

PHOENIX: OPEN INNOVATION TEST BED

Researchers of CIBER-BBN and NANBIOSIS, led by Nora Ventosa, are currently participating in another european project, PHOENIX “Enabling Nano-pharmaceutical Innovative Products” in the framework of which this novel nanomedicine developed under the Smar4Fabry project and designed as Orphan Drug by the EMA, will be scaled-up and manufactured under GMP to enable its clinical testing.

Articles of reference:

Josep Merlo-Mas, Judit Tomsen-Melero, José-Luis Corchero, Elisabet González-Mira, Albert Font, Jannik N. Pedersen, Natalia García-Aranda, Edgar Cristóbal-Lecina, Marta Alcaina-Hernando, Rosa Mendoza, Elena Garcia-Fruitós, Teresa Lizarraga, Susanne Resch, Christa Schimpel, Andreas Falk, Daniel Pulido, Miriam Royo, Simó Schwartz, Ibane Abasolo, Jan Skov Pedersen, Dganit Danino, Andreu Soldevila, Jaume Veciana, Santi Sala, Nora Ventosa, Alba Córdoba, “Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method”, The Journal of Supercritical Fluids, Volume 173, 2021, 105204, https://doi.org/10.1016/j.supflu.2021.105204.

Judit Tomsen-Melero, Solène Passemard, Natalia García-Aranda, Zamira Vanessa Díaz-Riascos, Ramon González-Rioja, Jannik Nedergaard Pedersen, Jeppe Lyngsø, Josep Merlo-Mas, Edgar Cristóbal-Lecina, José Luis Corchero, Daniel Pulido, Patricia Cámara-Sánchez, Irina Portnaya, Inbal Ionita, Simó Schwartz, Jaume Veciana, Santi Sala, Miriam Royo, Alba Córdoba, Dganit Danino, Jan Skov Pedersen, Elisabet González-Mira, Ibane Abasolo, and Nora Ventosa. Impact of Chemical Composition on the Nanostructure and Biological Activity of α-Galactosidase-Loaded Nanovesicles for Fabry Disease Treatment, ACS Appl. Mater. Interfaces 2021, 13, 7, 7825–7838 ( https://doi.org/10.1021/acsami.0c16871).

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1,800,000 euro for the improvement of NANBIOSIS laboratories

The final decision on the call for funding of Singular Scientific and Technical Infrastructures (ICTS) within the framework of the Recovery, Transformation and Resilience Plan in 2021 for has been published. These grants are intended to facilitate the execution of the Strategic Plans of the ICTSs included in the current National Map of ICTSs, through the execution of the investments provided for in their investment plans and declared of high priority by the Advisory Committee for Singular Infrastructures (CAIS).

Two applications were submitted to this call by NANBIOSIS: one by the CIBER node named “Towards a new generation of Infrastructure for the design, production and preclinical characterization of nanomedicines, biomaterials and biomedical systems in the units of the CIBER node of NANBIOSIS ” for the amount of € 2,522,128.02 of which € 1,785,706.36 have been granted, and another for the BIONAND node entitled “Update and improvement of the equipment of the BIONAND node of the NANBIOSIS distributed ICTS ”, for the amount of € 339,633.59, of which € 29,000 have been awarded.

These grants will allow the acquisition and improvement of the equipment and laboratories for the preclinical production and characterization of biomaterial nanomedicines and NANBIOSIS biomedical systems.

This call from the Ministry of Science and Innovation is funded with 37 million euros by the Recovery and Resilience Mechanism of the European Union. This is the first grant of aid for all ICTS in the last decade that is approved with funds from the General State Budget that finances 100% of the eligible costs and will allow the development and improvement of critical facilities for science and Spanish innovation. The Ministry of Science and Innovation has announced that in 2022 another call for 37 million euros will be published to finance actions of the new strategic plans of the ICTS 2021-2024.

The reinforcement of NANBIOSIS research capacities through these projects will result in a qualification of the research tissue at the national level necessary for the development of the next generation of advanced therapy drugs and diagnostic innovation linked to precision medicine and ensure the production of essential drugs.

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Vaccines against Covid, biomedical signal processing for sleep disorders and regenerative medicine, at the XV CIBER-BBN Annual Conference

The CIBER for Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN) will hold its XV Annual Congress, which will be held online for another year, on November 15 and 16. The conference will begin with a welcome that will be given by Cristóbal Belda, director of the ISCIII, and the scientific director of CIBER-BBN Ramón Martínez Máñez, and will aim to share advances in research in bioengineering, biomaterials and nanomedicine, in addition to advancing synergies with other disciplines and institutions.

This year’s edition will include three plenary talks given by internationally recognized experts in the fields of SARS-CoV-2 infection and vaccination, biomedical signal processing for sleep disorders, and regenerative medicine and biosensors.

In addition to a selection of internal collaborations, valorization projects and collaboration with the CIBER de Cáncer (CIBERONC), the CIBER-BBN researchers will be able to know first-hand the three programs of the Precision Medicine Infrastructure (IMPaCT) and the perspectives of NANBIOSIS ICTS.

Likewise, there will also be time to highlight the best works of young researchers in recognition of the best publications of 2020 with CIBER-BBN member authors under 30 years of age.

Access to the broadcast talks and subsequent debate is free after registering for the event at this link: https://jornadasanuales.ciber-bbn.es/

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CIBER renews its ISO 9001: 2015 Quality Certificate for its Management System

CIBER | October 14, 2021

CIBER, the main partner of NANBIOSIS obtained, last month, the ISO 9001: 2015 accreditation, issued by the ENAC (National Accreditation Entity) through TÜV Rheinland Ibérica Inspection, Certification and Testing SA, by which the quality in the CIBER management system is certified.

The scope of the quality management system defined in the certificate covers: “Staff and training management services, administrative accounting and communication management services for the Center for Biomedical Research on the Net”.

CIBER keeps updated the Quality Management System (QMS) designed to continuously improve the effectiveness and efficiency of performance, through the consideration of the needs of the interested parties, and to increase the satisfaction perceived by its clients. .

The CIBER obtained, in September 2021, the ISO 9001: 2015 accreditation, issued by the ENAC (National Accreditation Entity) through TÜV Rheinland Ibérica Inspection, Certification and Testing SA, by which the quality in the CIBER management system.

The scope of the quality management system defined in the certificate covers: “Personnel and training management services, administrative accounting and communication management services for the Center for Biomedical Research on the Net”.

The CIBER keeps updated the Quality Management System (QMS) designed to continuously improve the effectiveness and efficiency of performance, through the consideration of the needs of the interested parties, and to increase the satisfaction perceived by its clients. .

All the documented information related to the Quality Management System (QMS) implemented in CIBER, as well as the “Quality Manual” document are available in the “Document Manager” section of the CIBER Intranet. Likewise, the CIBER “Quality Policy” can be consulted on the Transparency Portal of the Web.

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Smart-4-Fabry final workshop

Next Wedneday, February 3, 2021 will take place the on-line event Smart-4-Fabry Final Workshop.  

Smart-4-Fabry is a european project, coordinated by CIBER-BBN wich has been developed during four years. This project is a sign of cooperation at European level to boost nanomedicine development and translation to clinical stages.

This project is also a clear example of the relevance of access to advanced research infrastructures as NANBIOSIS -ICTS. Four NANBIOSIS units have collaborated and contributed to Smart-4-Fabry development:

“The Fabry disease (FD) is a lysosomal storage disorder (LSD) that currently lacks an effective treatment” as Prof. Nora Ventosa, IP of the project, explained for NANBIOSIS blog – The aim of Smart-4-Fabry is to obtain a new nanoformulation of GLA, that will improve the efficacy and toleration compared to the actual treatment with non-formulated GLA.

In the final workshop experts will talk about how, why and for what the solution proposed by Smart4Fabry was conceived.

Registrations and program at https://smart4fabry.cientifis.com/

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NANBIOSIS in the new poster of ICTS map published by Spanish Goverment.

ICTS underpins the Spanish reputation for research excellence.

In the picture: the new poster of the ICTS map in which NANBIOSIS facilities have been highlighed with a red square

The term Unique Scientific and Technical Infrastructure (ICTS) refers to facilities, resources, or services for the development of top-quality cutting-edge research, as well as the communication, exchange, and preservation of knowledge, the transfer of technology, and promotion of innovation. They are unique or exceptional in their fields, with a high cost of investment, maintenance, and operation, and are of a strategic importance that justifies their availability to all actors in the field of R&D&I. The ICTS share three fundamental characteristics; they are infrastructures with public ownership, unique and open to competitive access.

ICTS offer an opening capacity percentage of their essential services under ‘Competitive Open Access’ for the use by national and international public and private sector researchers, with the support of technical and administrative personnel of the ICTS. Infrastructures access is ruled by a public “Access Protocol” that describes the procedure and criteria for access to the infrastructure. The main features of ‘Competitive Open Access’ are that R + D + i quality of activities developed at the infrastructure should be proven and that requests for access should be prioritized on the basis of objective criteria.

The dissemination of ICTS and their capabilities is essential to provide Spanish and international researchers with access to a large base of quality services and facilities, a basic requirement for the development of excellent science.

The new posster pushised by the General Subdirectorate of Large
Scientific-Technical Facilities of the of the Sapanish Ministry of Science and Research Innovation helps to disseminate and understand the map of ICTS wich are located throughout the country

NANBIOSIS, is one of the five ICTS in the field of Health Sciences and Biotechnology

Further informations: MICINN

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Scientists of Bionand, University of Malaga and CIBER identify a new drug that could mitigate the consequences of COVID infection.

Researchers from Bionand, partner of NANBIOSIS and ​​the University of Malaga toguether with Red de Terapia Celular, CIBER-BBN and CIBER-NED have taken another step in the search for new rapidly implantable therapies to stop the pandemic caused by the coronavirus disease, identifying a new drug that could prevent or mitigate the consequences of the SARS-CoV-2 infection.

The team, led by UMA researchers Iván Durán and Fabiana Csukasi, will study over the next year how treatment with 4-Phenylbutyrate (4-PBA) modulates the inflammatory response that occurs in the most severe cases of COVID-19.

The first results have already been published in the scientific journal ‘Cytokine and Growth Factors Review’

The inflammatory process that is identified in the most serious cases of coronavirus causes uncontrolled and excess cytokines – molecules responsible for organizing the body’s defenses – even triggering vascular hyperpermeability and multi-organ failure. Precisely, the control of this “storm” of cytokines, through those who control them, that is, the infected cells, is the proposal of the researchers from the University of Malaga.

“When cells are stressed by the infection they call up the cytokines and, the more stressed they are, the more insistently they call them, causing that uncontrolled inflammation. For this reason, one possibility to treat COVID-19 is to reduce the stress on the cells, “explained Durán.

According to the researcher, repositioning with the anti-stress drug ‘4-PBA’, approved for clinical use against other diseases and, therefore, easy to take to the clinic, could modulate this cellular stress, which is also present in pathologies such as diabetes, aging or carcinogenesis, in turn, classified as risk for Covid-19.

For further information click here

Other members of the Bioengineering and Tissue Regeneration Laboratory (Labret), led by Professor José Becerra, and of which the researchers Manuel Mari-Beffa, Gustavo Rico, José Miguel Tejeiro, Rick Visser and David Baglietto are also part of the team of researchers in this project granted by de Andalucía Government with 90.000€.

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NANBIOSIS AT THE CIBER-BBN ANNUAL CONFERENCE 2019

On October 21 and 22, CIBER-BBN has celebrated its 13th Annual Conference  in Tarragona, with a session dedicated to NANBIOSIS on the afternoon of Monday 21. The Singular Technical Scientific Infrastructure (ICTS) for the production and characterization of biomaterials, nanomaterials and devices up to its preclinical validation for the production and characterization of biomaterials, nanomaterials and devices up to its preclinical validation is integrated by of the CIBER-BBN, the Minimally Invasive Surgery Center Jesus Usón and Bionand after its incorporation to the ICTS last year. NANBIOSIS, presented its annual activity.

The Session was chaired by its Scientific Director, Jaume Veciana who also gave an Annual Summary, after that, the new unit 29 of NANBIOSIS, the Oligonucleotide Synthesis Platform, was presented by its Scientific Director Ramon Eritja Casadellà, from CIBER-BBN and Catalan Institute of Advanced Chemistry- CSIC . Finally, the Infrastructure for OMICS technologies (OmicsTech ICTS): metabolomics for clinical and nutritional research, was presented by Xavier Domingo-Almenara, Centre for Omics Sciences, EURECAT- Rovira i Virgili University.

After the NANBIOSIS Session, was the NANBIOSIS Scientificic Advisory Board meeting.

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CIBER-BBN Annual Conference 2019

In one month CIBER-BBN will celebrate its 13th Annual Conference on October 20 and 21 in Tarragona, at the Hotel Ciutat de Tarragona, Tarragona.

This year there several scientific sessions are planned about related leading issues with research topics of interest to CIBER-BBN. On Monday there will be three sessions centered in:

  • artificial intelligence and big data
  • gene editing and CRISPR and
  • liquid biopsy and point-ofcare.

Each of these sessions will include a plenary conference given by an expert
guest and two talks by BBN researchers, followed by an open debate.

The program will complete a session focused on the Singular Technical Scientific Infrastructure NANBIOSIS-ICTS.

On Tuesday, the four prizes will be awarded to the best scientific articles published by young researchers of CIBER-BBN during 2018 and there will be two other sessions on

  • nanobots and emerging drug administration technologies and
  • senescence and reprogramming

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