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News U6

News U6

A new european infrastructure will facilitate the transfer of nano-pharmaceuticals from the lab to the clinic

Launch of the cross-european PHOENIX project, which will provide a new infrastructure available to research laboratories, SMEs and start-ups to facilitate the transfer of nano-pharmaceuticals from the laboratory to clinical practice. PHOENIX will have a duration of 4 years and a total budget of 14.45 million euros. Two CSIC Institutes, ICMAB (CSIC) and INMA (CSIC-UNIZAR), and one CSIC spin-off, Nanomol Technologies, participate in the project, will count with the expertise of NANBIOSIS unit 6 (from CIBER-BBN and ICMAB-CSIC), led by Nora Ventosa.

PHOENIX is an innovation project funded by EU’s Horizon2020 Framework Programme aimed to provide services for the development, characterization, testing, safety assessment, scale-up, good-manufacturing-practice (GMPs) production and commercialization of nano-pharmaceuticals from the lab to the market, making them available to SMEs, startups, research laboratories and interested users.

A total of 11 partners from academia and industry located all across Europe have joined forces to create this “Open Innovation Test Bed” for nano-pharmaceuticals. Two CSIC institutes participate in this initiative: the Institute of Nanoscience and Materials of Aragón (INMA, CSIC-UNIZAR) and the Institute of Materials Science of Barcelona (ICMAB, CSIC), both groups members of the CIBER-BBN. Nanomol Technologies S.L., a growing SME spin-off from ICMAB-CSIC, is also partner of the project.

PHOENIX, which is coordinated by Luxembourg Institute of Science and Technology (LIST), supported by the german SME MyBiotech in scientific coordination, will have a duration of 48 months starting on 1 March 2021 with a total budget of €14.45 million and a requested EU contribution of €11.1 million.

Open Innovation Test Bed for nano-pharmaceuticals

Nano-pharmaceuticals are drugs that use nanotechnology (the use of matter on an atomic, molecular, and supramolecular scale for industrial purposes) in some form to achieve enhanced drug products. For example, contrast agents are used in the form of nanoparticles rather than a molecule because nanoparticles are more stable and can stay longer in blood. Another example could be that a nanoparticle is used as a nanocarrier to encapsulate the drug substance and protect it while enhancing adsorption and biodistribution, or to target the drug to specific tissues or organs.

Nano-pharmaceuticals have the potential to drive the scientific and technological uplift, offering great clinical and socioeconomic benefits to society in general, industry, and patients. Nevertheless, affordable and advanced testing, manufacturing facilities and services for novel nano-pharmaceuticals are main prerequisites for successful implementation of these advances to further enhance the growth and innovation capacity.

The establishment of current good manufacturing practices (GMPs) in nano-pharmaceutical production on a large scale is the key step to successfully transferring nano-pharmaceuticals from bench to bedside (from the lab to the patients). Due to the lack of resources to implement GMP manufacturing on site, the upscaling and production of innovative nano-pharmaceuticals is still challenging to the main players of EU nanomedicine market, start-ups and SMEs. To allow a successful implementation of nano-pharmaceuticals in the nanomedicine field, there is an urgent need to establish a science and regulatory-based Open Innovation Test Bed (OITB).

PHOENIX: key project in taking nano-pharmaceuticals from bench to bedside

The PHOENIX project aims to enable the seamless, timely and cost-friendly transfer of nano-pharmaceuticals from lab bench to clinical trials by providing the necessary advanced, affordable and easily accessible PHOENIX-OITB which will offer a consolidated network of facilities, technologies, services and expertise for all the technology transfer aspects from characterisation, testing, verification up to scale up, GMP compliant manufacturing and regulatory guidance.

PHOENIX-OITB will develop and establish new facilities and upgrade existing ones to make them available to SMEs, starts-up and research laboratories for scale-up, GMP production and testing of nano-pharmaceuticals, either based on small chemical molecules or biologicals The services and expertise provided by the OITB will include production and characterisation under GMP conditions, safety evaluation, regulatory compliance and commercialisation boost.

“Our goal is to create a new infrastructure at European level available for all research centres and laboratories, SMEs and start-ups, to facilitate the transfer of nano-pharmaceuticals from the lab to the clinical practice” explains Jesús Martínez de la Fuente, INMA-CSIC-UNIZAR researcher.

“The role of INMA and ICMAB is to generate new services, open to the public, to characterize nano-pharmaceuticals in rder to ensure their quality” affirms Nora Ventosa, ICMAB-CSIC/CIBER-BBN researcher and Director of NANBIOSIS unit 6 Biomaterial Processing and Nanostructuring Unit.

Project partners

The 11 partners that form the PHOENIX consortium are the Luxembourg Institute of Science and Technology (LIST, Luxembourg), MyBiotech (SME from Germany), Nanomol Technologies SL, LeanBio SL and Grace Bio SL (SMEs from Spain), Cenya Imaging B.V. (SME from The Netherlands), BioNanoNet Forschungsgesellschaft mbH (BNN, Austria), CSIC (INMA, CSIC-UNIZAR and ICMAB, CSIC), Institute for Medical Research and Occupational Health (IMROH, Croatia), Research Center Pharmaceutical Engineering GmbH (RCPE, Austria), and Topas Therapeutics GmbH (Germany).

More information:

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A more effective nanomedicine has been developed for the treatment of Fabry rare disease.

28 February: International Rare Disease Day

  • This is one of the major achievements of the European Smart4Fabry project, which is now coming to an end after four years of work.
  • The results have been made possible by nanotechnology and the approach developed could be applied to other drugs in the future.
  • The new drug improves on current treatments and helps reduce costs and improve patients’ quality of life.

Barcelona, 26 February 2021.- The advance of nanomedicine opens up new possibilities in the development of drugs, such as the one recently developed for the rare disease Fabry, with improved efficacy compared to existing authorised treatments.

Thus, the European Smart4Fabry project has come to an end with one of the best results possible: the designation of a new orphan drug by the European Commission and the possibility of making progress in the treatment of Fabry, a rare disease that is estimated to affect approximately 2.6 out of every 10,000 people in the EU.

It is a chronic debilitating disease due to recurrent episodes of severe pain that is difficult to control with conventional analgesics, and it is life-threatening due to renal failure and associated cardiovascular and cerebrovascular complications.

With this designation we have made a major achievement, not only for Fabry patients, but also for other pathologies that can benefit from this same approach, made possible by nanotechnology,” explained Nora Ventosa, Scientific Director of NANBIOSIS Unit 6 Biomaterial Processing and Nanostructuring Unit of CIBER-BBN and ICMAB-CSIC who coordinated the project.

Need for new treatments for the disease

This disease, also known as Anderson-Fabry disease, represents the most common lysosomal storage disorder. It is caused by an absence or deficiency of the enzyme α-galactosidase A (GLA), which results in the lysosomal accumulation of globotriaosylceramide (Gb3) and its derivatives in the lysosomes of a wide variety of tissues, responsible for the clinical manifestations. Current treatments consist of intravenous administration of the GLA enzyme, but have limited efficacy and poor biodistribution.

The drug that has been developed is a new nanoformulation of GLA (nanoGLA) that improves efficacy compared to the reference treatment with non-nanoformulated GLA. “The third-generation liposomal product we have developed in the project has demonstrated, at preclinical level, improved efficacy, compared to authorised enzyme replacement treatments, demonstrating that the strategy of supplying the affected cells with the GLA enzyme via the smart nanoliposome is highly successful”, explained Ibane Abasolo, Scientific Coordinator of NANBIOSIS U20 of CIBER-BBN and VHIR, who is responsible for the efficacy studies in the project.

The nanoGLA product was obtained using DELOSTM formulation technology, an innovative platform for the robust production of nanomedicines in an efficient and sustainable manner.

The Committee for Orphan Medicinal Products, the European Medicines Agency’s (EMA) committee responsible for recommending orphan designation of medicines for rare diseases, has considered these results to have a clinically relevant advantage over current enzyme replacement therapies.

The designation of orphan drug, in addition to recognising the significant benefit of the new nanomedicine over products already licensed for Fabry disease, has important implications for the translation of the new therapeutic product from bench to bedside.

Those responsible for these results, including several CIBER-BBN groups, highlight that the new formulation helps to improve treatments, reduce costs, and improve the quality of life of Fabry patients.

Interdisciplinarity and public-private collaboration

The Smart4Fabry project has been running since 2017 thanks to European funding of €5.8 million, from the Horizon 2020 programme. This was possible thanks to the collaboration of several CIBER-BBN groups and NANBIOSIS Units at the Institute of Materials Science of Barcelona (ICMAB-CSIC) with the abouve mentioned NANBIOSIS Unit 6, the Institute for Advanced Chemistry of Catalonia (IQAC-CSIC) with NANBIOSIS Unit 3 of
Synthesis of Peptides Unit
, led by Miriam Royo, the Vall d’Hebron Research Institute (VHIR) with NANBIOSIS Unit 20 and the Institute of Biotechnology and Biomedicine of the Autonomous University of Barcelona (IBB-UAB) with NANBIOSIS Unit 1 Protein Production Platform (PPP), whose work in this project was led by José Luis Corchero. It has also been necessary to contribute knowledge from different academic and business disciplines.

The project consortium also includes public institutions such as the University of Aarhus (Denmark), Technion Israel Institute of Technology (Israel) and Joanneum Research (Austria); and the companies Biokeralty (Spain); Nanomol Technologies SL (Spain); BioNanoNet (Austria), Drug Development and Regulation SL (Spain), the Covance Laboratories LTD group (UK) and Leanbio SL (Spain), which have provided the necessary expertise in nanotechnology and biotechnology, physicochemical characterisation, in vitro and in vivo biological evaluation, formulation and grading of nanomedicines, and pharmaceutical development and production under the guidelines of regulatory agencies.

CIBER and CSIC, promoters of orphan drugs

Orphan Drug Designations (ODDs) seeks to facilitate the arrival of treatments for rare diseases on the market. Several incentives are associated with ODDs, such as market exclusivity, fee reductions and specific scientific advice.

To date, CIBER has promoted eleven orphan drugs designated by the EMA, mainly from the thematic area of Rare Diseases (CIBERER), this being the first from CIBER-BBN.

On the other hand, this is the fourth ODD that the CSIC has obtained, and the first time it refers to a nanoformulated drug.

Orphan drug designation by the European Medicines Agency has several advantages, such as receiving a commercialisation authorisation for 10 years during which similar products cannot be commercialised, the availability of free or low-cost scientific advice and support protocols, and exemption from designation fees. In addition, entities developing orphan drugs have access to specific grants from the European Union and member states’ programmes.

More information

Scientific Culture Unit UCC+i CIBER cultura.cientifica@ciberisciii.es

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NANBIOSIS Scientific Women in the International Day of Women and Girls in Science

Today February 11 is the International Day of Women and Girls in Science, a day to raise awareness of the gender gap in science and technology.

According to the United Nations, while yet women and girls continue to be excluded from participating fully in science, science and gender equality are vital to achieve the internationally agreed development goals, including the 2030 Agenda for Sustainable Development. Thus, in recent years, the international community has made a great effort to inspire and promote the participation of women and girls in science.

NANBIOSIS wants to acknowledge  the efforts made by scientific women who struggle every day to contribute their bit to Science and highlight their essential role in nowadays research. Especially we want to recognize the work of scientists women involved in NANBIOSIS, whatever is the nature of their contribution: technical, scientific development, management, coordination, direction, etc; just to mention some examples:
Neus Ferrer and Mercedes Márquez in the Scientific Direction and Coordination of Unit 1 Protein Production Platform (PPP)
Pilar Marco and Nuria Pascual in the Management and Scientific Coordination of U2 Custom Antibody Service (CAbS) 
Miriam Royo in the Scientific Direction of U3 Synthesis of Peptides Unit
Nora Ventosa and Nathaly Segovia in the Scientific Direction and Technical Coordination of U6 Biomaterial Processing and Nanostructuring Unit
Isabel Oliveira and Teresa Galán in the Coordination of U7 Nanotecnology Unit
Rosa Villa and Gemma Gabriel in the Management and Scientific Coordination of U8 Micro – Nano Technology Unit
Gema Martínez in the Scientific Coordination of U9 Synthesis of Nanoparticles Unit
Fany Peña in the Scientific Coordination of U13 Tissue & Scaffold Characterization Unit
Mª Luisa González Martín and Margarita Hierro in the of Direction and Scientific Coordination of U16 Tissue & Scaffold Characterization Unit
Gemma Pascual and Isabel Trabado in the Coordination of the U17 Confocal Microscopy Service
Isolda Casanova in the Scientific Coordination of U18 Nanotoxicology Unit
Beatriz Moreno in the Scientific Direction of Unit 19 Clinical tests lab
Ibane Abásolo in the Scientific Coordination of Unit 20 In Vivo Experimental Platformt
Verónica Crisóstomo in the Scientific Direction of Unit 24 Medical Imaging 
Ana Paula Candiota in the Scientific Coordination of Unit 25 Biomedical Applications I 
Maria Luisa García in the Scientific Direction of U28 NanoImaging Unit from Bionand, recently incorporated to NANBIOSIS, Anna Aviñó in the Scientific Coordination of U29 Oligonucleotide Synthesis Platform (OSP) – and

Nerea Argarate in the coordination of NANBIOSIS

Thanks to all of you and your teams!

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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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Mimicking lymph-nodes to proliferate T cells by Judith Guasch in Onda Cero Radio.

Judith Guasch, researcher from Nanomol group, coordinator of NANBIOSIS unit 6 of NANBIOSIS (CIBER-BBN / ICMAB-CSIC)  is interviewed in Onda Cero Radio  in the programme “De cero al infinito” con Paco de León, to talk about her recent research on hydrogels to mimic lymph nodes for cancer immunotherapy. 

You can listen the interview to Judith Guasch in this link, from minute 11: 33 to minute 29:35. In her interview, Judith Guasch explains her research on hydrogels to mimic lymph modes to grow more effectively T cells for cancer immunotherapy, about the patent, the costs of the cancer immunotherapy, and about the 3D bio-printing and scaling up of the hydrogels to increase the proliferating of T cells. 

Further information at ICMAB-CSIC web page

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Two new equipment items at the U6 of Nanbiosis with cofinancing from FEDER funds

The U6 of NANBIOSIS (Biomaterial Processing and Nanostructuring Unit) has expanded its capabilities with 2 new equipment items for the characterization unit. Both equipment items will allow the characterization of some physico-chemical properties of different nanomaterials.

The Zetasizer ULTRA is used to measure the particle size of dispersed systems from sub-nanometer to several micrometers in diameter, using the technique of Dynamic Light Scattering (DLS). Zetasizer systems are also used to analyze particle mobility and charge (Zeta potential) using the technique of Electrophoretic Light Scattering (ELS), and the molecular weight of particles in solution using Static Light Scattering (SLS).

The Green laser module for the NanoSight NS300 equipment. The NS300 allows analysis of the size distribution and concentration of all types of nanoparticles from 0.01 – 1 µm in diameter. This new laser module will allow NTA to measure a range of fluorescent particles, avoiding interferences during the measurements due to sample (auto)fluorescence and absorption.  This is done by detecting the fluorescence signal, which is emitted naturally by particles or as a result of fluorescence labeling or tagging


This equipment have been confinanced by the European Regional Development Fund (ERDF) through the Plurirregional Operational Program of Spain (POPE)2014-2020

European Regional Development Fund
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Third edition of the course on “Characterization techniques for Particulate Materials” with Amable Bernabé

The Soft Matrials Lab at ICMAB-CSIC, run by Amable Bernabé (NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit, hosted from Monday, 5 October, to Wednesday, 7 October a course on “Characterization techniques for particulate materials”.

The course was an introduction to different techniques to characterize nanoparticles and other particulate matter, including the basic fundamentals, sample preparation, practical examples and results interpretation. 

Due to the COVID-19 pandemic, the participants of the course were less than in previous years, and during the practical sessions the group was divided, so less people was at the same time inside the lab, and the safety measures could be kept. 

Theory:

  • Dynamic Light Scattering (DLS) with Zetasizer Nano ZS (Malvern Instruments)
    • Size distribution
    • Z Potential 
  • Nanoparticle Tracking Analysis (NTA) with Nanosight NS300 (Malvern Instruments)
    • Size distribution
    • Particle concentration
    • Fluorescence
  • Light Scattering (LS) with Mastersizer 2000 (Malvern Instruments)
    • Size distribution

Practice:

  • Sample analysis and practical cases of Dynamic Light Scattering with the Zetasizer Nano ZS (Malvern Instruments) equipment.
  • Samples analysis and practical cases of the Nanoparticle Tracking Analysis (NTA) technique with the Nanosight NS300 (Malvern Instruments) equipment.
  • Sample analysis and practical cases of the Light Scattering (LS) technique with the Mastersizer 2000 (Malvern Instruments) instrument.

Source of information ICMAB-CSIC

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Novel Quatsome nanovesicles, prepared using compressed CO2, for the development of advanced nanomedicines

Guillem Vargas Nadal, researcher at Nanomol Group – NANBIOSIS U6 (ICMAB-CSIC and CIBER-BBN) and Nanomol Technologies will defend his PhD thesis on Friday, 23 October 2020, at 11 am in an online session. The PhD Thesis Defense will be held by videoconference from the ICMAB Meeting Room. 

Further information and Registration to attend the PhD Thesis defense via Zoom nanoparticles at ICMAB-website.

Supervisors:

  • Nora Ventosa (Scientific Director of NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit and leader of Nanomol Group of CIBER-BBN
  • Lidia Ferrer (Nanomol Technologies S.L.)

Abstract: The nanovesicles are being developed and investigated to be used in the pharmaceutical world to deliver drug and detect diseases. However, there are some drawbacks related to the nanovesicles that must be considered, like their stability and their applicability. Concerning that, in this Thesis we have developed a new type of stable nanovesicles called MKC-Quatsomes to be used as intravenous drug delivery systems. Their production, physicochemical characteristics, and stability are strongly related to the dispersant medium. Furthermore, the MKC-Quatsomes were labeled with fluorescent organic dyes, which present FRET phenomenon in order to overcome the drawbacks of the single-dye-loaded nanoparticles.


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Workshop “Translational issues in nanomedicine” with NANBIOSIS U6 researchers at ETPN2020

ETPN2020, the 15th annual event of ETPN, European Technology Platform on Nanomedicine will take place, fully virtual on Oct. 14-15 to share the latest trends and success stories in Nanomedicine and emerging Medtech.

In the frame of ETPN2020, on thursday Oct, 15, 12:00 will tak place the Workshop “Translational issues in nanomedicine” the workshop “Translational issues in nanomedicine” organized jointly by ETPN2020 and NMBP projects. Nora Ventosa, Scientific Director of NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit, will participate as coordinator of the european project Smart 4 Fabry

The workshop chairs will be Fabrice Navarro (Head of Laboratory at CEA LETI, France) and Alan Boyd (CEO & Founder of Boyds) (NEW DEAL H2020 project)

Registration deadline: Monday 12th October 2020 16:00 CET

Registration for free for the workshop for the NMBP projects, here:

To follow the complete ETPN event (ETPN members are free), click here

The latest version of the agenda is now to be found on: http://www.etpn2020.eu/e-program/

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Impact of Extracellular Vesicle Isolation Methods on Downstream miRNA Analysis in Semen

An article by Sara Larriba of the Human Molecular Genetics Group of Bellvitge Biomedical Research Institute (IDIBELL), recently published by the International Journal of Molecular Science. entitled “Impact of Extracellular Vesicle Isolation Methods on Downstream miRNA Analysis in Semen: A Comparative Study“, acknowledges NANBIOSIS ICTS for its participation in the research results. The nanoparticle tracking analysis was performed by the ICTS NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit.

Abstract:

Seminal plasma (SP) contains a unique concentration of miRNA, mostly contained in small extracellular vesicles (sEVs) such as exosomes, some of which could be clinically useful for diagnosis and/or prognosis of urogenital diseases such as prostate cancer (PCa). We optimized several exosome-EV isolation technologies for their use in semen, evaluating EV purifying effectiveness and impact on the downstream analysis of miRNAs against results from the standard ultracentrifugation (UC) method to implement the use of SP sEV_miRNAs as noninvasive biomarkers for PCa. Our results evidenced that commercial kits designed to isolate exosomes/EVs from blood or urine are mostly applicable to SP, but showed quantitative and qualitative variability between them. ExoGAG 3500× g and the miRCURY Cell/Urine/CSF 1500× g methods resulted as equivalent alternative procedures to UC for isolating exosomes/sEVs from semen for nanoparticle characteristics and quality of RNA contained in vesicles. Additionally, the expression profile of the altered semen sEV-miRNAs in PCa varies depending on the EV isolation method applied. This is possibly due to different extraction techniques yielding different proportions of sEV subtypes. This is evidence that the exosome-EV isolation method has a significant impact on the analysis of the miRNAs contained within, with important consequences for their use as clinical biomarkers. Therefore, miRNA analysis results for EVs cannot be directly extrapolated between different EV isolation methods until clear markers for delineation between microvesicles and exosomes are established. However, EV extraction methodology affects combined models (semen exosome miRNA signatures plus blood Prostate specific antigen (PSA) concentration for PCa diagnosis) less; specifically our previously described (miR-142-3p + miR-142-5p + miR-223-3p + PSA) model functions as molecular marker from EVs from any of the three isolation methods, potentially improving the efficiency of PSA PCa diagnosis..

Article:

Impact of Extracellular Vesicle Isolation Methods on Downstream miRNA Analysis in Semen: A Comparative Study. Marina Mercadal, Carolina Herrero, Olga López-Rodrigo, Manel Castells, Alexandre de la Fuente, Francesc Vigués, Lluís Bassas and Sara Larriba. Int. J. Mol. Sci. 2020, 21, 5949; doi:10.3390/ijms21175949

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