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In the frame of the main European event on nanotechnology, CIDETEC will present the Project of the first plant in Europe for the production of polymeric nanoparticles

ImagineNano’s third edition started last Tuesday, 10th March. The major nanoscience and nanotechnology European meeting congregates the main nanotechnology actors and constitutes a bridge between the scientific community and industry.

 

The event, which finishes next Friday 13th March, has been organized by the Phantoms Foundation, the Center of Cooperative Investigation (CIC) nanoGUNE, the Donostia International Physics Center (DIPC), the Basque Country’s University (UPV/EHU) and the Bilbao Exhibition Centre (BEC).

 

Besides the conferences, ImagineNano has a wide program that includes an industrial forum designed to promote meetings, identify business opportunities and stimulate networking, and an exhibition area with more than one hundred of exhibitors that present the most innovative technologies related to nanoscience.

 

During the closing session, CIDETEC will present his capacities in nanotechnology, focusing on the presentation of NANOPILOT project. The main objective of the project, led by CIDETEC and with the support of the European Commission, is the construction of the first European production plant of polymeric nanoparticles for the pharmaceutical industry. This plant, which aims to accelerate the step between scientific experimentation and clinical test phases, will produce small size batches that will be used in clinical tests for the treatment of cystitis, dry-eye syndrome and AIDS.

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NANOPILOT project members meet at CIDETEC to celebrate the project’s launch

The official meeting to launch the NanoPilot project was held on 14 and 15 January at CIDETEC. This initiative aims to build a pilot line for the production of polymer-based nanopharmaceuticals in compliance with GMP (Good Manufacturing Practices) standards.

By funding this project, with a total cost of €6 million over four years, the EU wants to increase the transfer of technology to the business sector, and thus to society, in order to promote the production and validation of new nanotechnology-based drugs.

As already published in several media outlets that have picked up the news, the manufacturing of these products cannot be easily implemented in existing manufacturing plants at large companies, which are specialised and optimised for the production of conventional drugs. Moreover, small businesses and research centres generally lack the resources to scale and implement manufacturing of new nanopharmaceuticals with GMP standards. Therefore, these organisations are limited in terms of research advancement, resulting in a slowdown in the development of innovative nanopharmaceuticals for the treatment of different diseases.

The consortium partners had the opportunity to visit CIDETEC’s new facilities, the site of the new pilot plant that will allow the partners to carry out product development through to clinical stages, a phase that requires batches of products manufactured according to strict quality standards.

Along these same lines, the meeting also served to bring to light the different specifications that must be taken into account in order to comply with the standards required by the Regulatory Agency for Medicines, as well as to develop a work plan based on the needs of each of the innovative developments proposed by the consortium members.

The NanoPilot project has begun designing a plan that ensures that the pilot plant obtains GMP certification, in turn making possible the GMP-compliant production of three nanopharmaceuticals based on polymeric nanoparticles for different diseases such as interstitial cystitis or painful bladder syndrome, dry eye syndrome and a new HIV vaccine.

Through this research, CIDETEC and the NanoPilot members will strive to position the project at the forefront of international nanomedicine, responsibly facing the enormous challenge of contributing to the betterment of society by successfully achieving the project’s objectives.

 

Consortium: UT2A-ADERA (FR); National University of Ireland, Galway (IE); Universidad de Santiago de Compostela (ES); Sylentis (ES); Chemtrix (NL); iX-Factory (DE); Mejoran (ES); Spinverse (FI) and CIDETEC (ES).

 

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Three European projects enter the finalisation stage of their EU Grant Agreements, driving forward the implementation of the ETPN Translation Hub.

A major step in implementing the ETPN Translation Hub (an umbrella of dedicated new infrastructures, programmes and projects to enhance the innovation capacity of SMEs and academia in order to accelerate the development of nanomedicines towards the market) has been reached, with three European projects entering the finalisation stage of their EU Grant Agreements. The project ENATRANS is for networking of SMEs in the nano-biomedical sector and supporting the SMEs with getting their products from the laboratory phase to the clinical applications.  The projects ‘NANOFACTURING’ and ‘NANOPILOT’ will establish pilot lines to scale-up the production of novel nanopharmaceuticals from the lab-scale to the quantities needed for clinical testing.

 

The ENATRANS project (Enabling NAnomedicine TRANSlation) will ensure the global coherence of the Translation Hub and build a functioning supply chain of nanomedicine projects mainly ran by SMEs and ready to meet industrial and clinical needs. A Translational Advisory Board (TAB) will serve as the cornerstone to provide specific advice, guidance and recommendations to all nanomedicine actors dealing with translation issues and in need of assistance in specific areas of expertise.

Coordinator: ETPN Secretariat c/o VDI/VDE-IT (DE)

Consortium: Nanobiotix (FR), CEA-Leti (FR), Bioanalytik Muenster e.V. (DE), Tel-Aviv University (IL), Fondazione Don Carlo Gnocchi ONLUS (IT), and TecMinho (PT).

Duration: 3 years – Budget: € 2 Mio.

 

The NanoFacturing project has two principal objectives. Firstly to scale up an existing Good Manufacturing Practice (GMP) pilot line to a medium scale sustainable manufacturing process for solid core nanopharmaceuticals with a primary focus on glycan-coated gold nanoparticles. The process will also support consortium partners’ clinical programs such as IFOM’s antiviral Dengue fever NP and other EU-wide nanomedicine programs. Secondly to create a large scale process platform that would serve as the basis for GMP compliant industrial manufacture and that will be available as a model for other European companies wishing to develop their own products.

Coordinator: Midatech Biogune (ES)

Consortium: Centre for Process Innovation Limited (UK), Prochimia Surfaces SP.Z.O.O (PL), Galchimia S.A (ES), the University College Dublin and the National University of Ireland (IE), Applus S.A. LGAI Technological Center, S.A (ES), IFOM, Fondazione Istituto FIRC di Oncologia Molecolare (IT), and Ecole Polytechnique Federale de Lausanne (CH).

Duration: 4 years – Budget: € 8 Mio.

 

The NanoPilot project will build a pilot line for the production of polymer based nanopharmaceuticals in compliance with GMP. The size of the plant aims to be very small, with three systems to be produced at the end of the project. Continuous flow microreactors will be employed for two of the nanopharmaceuticals to be manufactured.

Coordinator: CIDETEC Research Centre (ES)

Consortium : A Research Institute – UT2A-ADERA (FR); two Universities – National University of Ireland, Galway (IE) and Universidad de Santiago de Compostela (ES) ; two industries – Sylentis (ES) and Chemtrix (NL) ; and three SMEs – iX-Factory (DE), Mejoran (ES) and Spinverse (FI).

Duration: 4 years – Budget: € 6, 28 Mio.

 

This announcement has taken place at the ETPN Annual Event 2014 that is being celebrated in San Sebastian (Spain) from October 15th to 16th, kindly co-organised by the nanoBasque Agency (SPRI) and hosted by CIC nanoGUNE, the Basque nanoscience cooperative research centre.

Patrick Boisseau, chairman of the ETPN, has added:

“We are very proud to announce such important news during the ETPN Annual Event 2014. The success of the EU calls – 18 proposals have been received for pilot lines for upscaling the manufacturing of nanopharmaceuticals – shows the adequacy of ETPN recommendations with real SMEs needs. We also look forward for the perspectives on a nano-characterisation infrastructure, another major pillar of the Translation Hub asked by European nanomedicine actors. The ETPN is excited to work hand in hand with the different coordinators for a global coherence of actions and a more efficient European value chain in nanomedicine.”

 

About ETPN ‐ www.etp‐nanomedicine.eu

The European Technology Platform Nanomedicine was established in 2005 as a joint initiative of the European Commission and CEOs of large industrial companies, SMEs and academic research institutions to investigate and advance joint activities in the area of nanotechnology in medicine. Since 2005 the ETPN published a number of strategic documents, roadmaps and structural requirements for an efficient translation of R&D results into innovative nanomedicine. The ETPN supports its members in coordinating their joint research efforts and improving communication amongst the members as well as towards the European Commission and the European Member States.

ETPN Secretariat – ENATRANS Coordinator

Nicolas Gouze

Head of Secretariat

nicolas.gouze@vdivde-it.de

 

About Midatech – http://midatechgroup.com/

Midatech is a world leader in the design, synthesis and manufacture of biocompatible gold nanoparticles (GNPs) with a core focus on therapeutics for diabetes and cancer. The Company is also exploring the use of GNPs in other healthcare applications including vaccines, diagnostics and medical imaging.

Midatech – NanoFacturing Coordinator

Justin Barry

CEO Midatech Biogune S.L.

barry@midatech.eu

 

About CIDETEC – cidetec.es

CIDETEC is specialised in generating and transferring knowledge and technology in the areas of materials, surfaces and energy. NanoPilot will be coordinated by the CIDETEC Biomaterials Unit specialised in the synthesis and characterisation of biomaterials (polymer nanoparticles, colloids, hydrogels and bioactive surfaces).

CIDETEC – NanoPilot Coordinator

Dr. Iraida Loinaz

Head of Biomaterials Unit

iloinaz@cidetec.es

 

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CIDETEC leads the European consortium to fight antibiotic-resistant bacterial infections.

Ø The 6 million euro budget project, counts with the presence of large companies, research centres and universities in Europe


 


Ø The treatment will include a diagnostic kit that will quickly and accurately identify the type of bacteria that causes the infection and an inhaler that will dispense the drug effectively.


 


Incidence of infections from resistant bacteria is causing alarm worldwide. It is estimated that each year about 400,000 patients in Europe suffer from what is known as resistant infections, of which 25,000 die yearly. These diseases involve certain additional costs in treatments and lost work productivity estimated at about 1.5 billion euros per year. The problem is even greater, considering the low number of active ingredients in development. In a 2009 study carried out in Europe, only 15 systemic application antibacterial agents based on new targets or novel action mechanisms were recorded as being at clinical stages.


Because of the above, in 2013, the European Union launched an action plan aimed at funding research projects based on this topic, approaching the problem from different perspectives (new treatments, prevention, resource optimization…). PneumoNP, one of the projects funded and led by CIDETEC, aims to attract a new treatment against pneumonia caused by Gram-negative resistant bacteria. The treatment will integrate a diagnostic kit to quickly and accurately determine the particular type of organism causing the infection, and a new inhaler capable of effectively administering the dose of the drug through the use of nanoparticles.


One of the reasons why bacteria become resistant is because of the misuse and abuse ​​of antibiotics. Resistant bacteria become immune to conventional antibiotics, which is why the development of drugs that have antimicrobial activity by using different routes to traditional antibiotics, has a great chance of becoming new star drugs.


PneumoNP addresses the development of two new active ingredients, but also aims to direct the drugs by means of nanoparticles directly into the lungs using inhalers, and avoiding side effects. In order to avoid the unnecessary use of broad-spectrum antibiotics, PneumoNP will be developing a diagnostic kit that will identify the particular strain that causes the infection and will allow for the selection of the most effective treatment easily and reliably.


To test the efficiency and safety of the developed Nano systems and to allow them to become drugs, the PneumoNP consortium counts on renowned European partners who will develop all the necessary in vitro and in vivo testing needed to reach the clinical phase (trials in humans). Apart from the Fraunhofer Institute in Germany and the Erasmus Medical Center in the Netherlands, the research centre, CIC biomaGUNE, will also be involved in all related to radiology studies in order to observe the bio distribution of the Nano systems. CIDETEC also counts on the appropriate facilities to manufacture Nano systems under the most stringent quality certifications required for the elaboration of drugs.


It should be mentioned that the PneumoNP consortium intends to enter the new strategic model called “Open Innovation (OI).” This model is the result of the huge changes that are taking place in the pharmaceutical industry due to patent expirations and subsequent competition from generic drug manufacturers. In the past, the same company carried out the whole drug research phase and development, while now products that have been developed by third parties and need to complete clinical phases for future marketing are now licensed.


PneumoNP began operations in January 2014 and the opening meeting will take place on 28th and 29thJanuary at CIDETEC headquarters in the Scientific and Technological Park of Gipuzkoa. The total budget for 4 years is about 6 million euros and comes as a great challenge for the consolidation of CIDETEC in the emerging field of Nano medicine research.

 

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