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Nanomedicine Translation Hub

Nanomedicine Translation Hub

 

Innovation in nanomedicine is mostly taking place in start-ups, SMEs and spin-offs from academia who usually have an outstanding knowledge about their product, its characteristics, its properties, its impact in vitro or sometimes in vivo, because they are either at the origin of the technology or have joined the team who was at the origin.

However these entrepreneurs start facing some major difficulties when translating their concept towards the market.


The reason is that research on a new nanoformulation requires totally different skills from transforming it into an industrial product, especially in healthcare which is a heavily regulated market. These difficulties are for instance in the ultra fine characterisation of their product and its scale up manufacturing in GMP grade to produce the first clinical batches. Besides, young entrepreneurs are lacking coaching and mentoring to materialize their visions in successful start-ups, making the right decisions at the right time.

ETPN, the European Technology Platform for Nanomedicine, has encouraged in 2015 the submission of complementary proposals under H2020 Framework Programme tackling the limitations previously listed, under a single umbrella. The importance of this new Nanomedicine Translation Hub for the emerging industrial sector in nanomedicine has been recognised by the European public authorities which are funding 5 European projects, completely aligned with this Hub concept:

  • ENATRANS with the Nanomedicine Translation Advisory Board (TAB) as cornerstone
  • EUNCL, the European Nanomedicine Characterisation Laboratory
  • 3 pilot lines for scale up manufacturing of nanomaterials for medical applications: NanoPilot, NanoFacturing and MACIVIVA

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After two years of operation, the Nanomed Translation Hub has proven its relevance. It has contributed to the development of several tens of start-ups and SMEs on different aspects of their paths to market. The Nanomed Translation Hub is definitely a new approach with tailored services targeted to nanomed start-ups and SMEs.

Currently following items are in operation and offer services for translation to the Nanomedicine Community:

ENATRANS

ENATRANS’ main objective is to network and support SMEs in translation of nanomedicine in Europe by providing a one-stop-shop service to interact and share information, experience and advice with up-to-date information and interactive tools, but also enabling personal contacts. ENATRANS implements the concept of a Translation Advisory Board (TAB) with senior experienced translation experts to guide R&D teams (in SMEs and research institutes) along the translation process to successfully make it to clinical trials and later to the market.

Furthermore ENATRANS bundles stakeholders, capacities and knowledge within and beyond the nanobiomedical community in order to accelerate translation of individual projects but also to advance the whole sector.

EU-NCL

The EU-NCL aims at fostering innovation in Nanomedicine by providing access to state of the art full characterisation of nanomaterials intended for medical applications, developed by public labs, spin –offs and innovative SMEs. The EU-NCL shall also serve as a European knowledge base for researchers and industry ensuring that European knowledge is documented in Europe for the benefit of the European economy, healthcare systems and patients. The EU-NCL provides a comprehensive set of characterisation tests (physical, chemical, in vitro and in vivo biological properties) allowing researchers and SMEs to better understand or predict the clinical in vivo effects of their medical nanomaterials. On top of that, a full characterisation is required by regulation agencies before approval of any tests on human beings.. The knowledge base to be developed by EU-NCL will help the European Medicines Agency (EMA) or other relevant agencies (e.g. notified body) to adapt the current regulation and approval process to Nanomedicine products. Further links with EURAMET (standardisation of analytical methods of nanomedical nanomaterials) as well as with the nanomaterials eco-toxicity initiative will be implemented in order to share some analytical methods and equipment. The EU-NCL has also a strategic and political role in helping newcomers, like spin-offs or SMEs, in getting an easy access to nanocharacterisation and further to prepare their submission for product approval.
http://www.euncl.eu/

NANOFACTURING

The NanoFacturing project has two principal objectives. The first consists of scaling 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 programmes such as the antiviral dengue fever nanopharmaceuticals at the Italian Foundation for Cancer Research’s Institute of Molecular Biology, and other EU-wide nanomedicine programmes. The second objective is 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.
http://nanofacturing.eu/

NANOPILOT

The NanoPilot project will build a GMP pilot line for the production of polymer-based nanopharmaceuticals. 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.
http://www.nanopilot.eu

MACIVIVA

MACIVIVA is a highly interdisciplinary consortium among well established and innovative SMEs with scientific excellence and complementary industrial world-leading experts with unique expertise and know-how in virosome technology, spray and freeze drying, large scale manufacturing and packaging. MACIVIVA will pave the path to other large scale thermostable nanopharmaceuticals products for therapeutic and prophylactic vaccines and other potential applications for direct application by non-invasive routes.
Liquid products are inherently prone to physical and/or chemical modifications and degradations. Solid vaccine dosage formats (e.g. powder) may prevent molecular motion and shear-induced degradation, and slow down degradation involving water and oxygen radicals, resulting in improved stability and enhanced shelf-life of vaccines. The cold chain storage is still fundamental for preserving the bioactivity of most liquid and freeze-dried vaccines, and a reconstitution step prior to administration is required for freeze dried vaccines that are usually administered intramuscularly or subcutaneously. These reconstituted freeze dried vaccines harbor important instability and must be used within hours and kept refrigerated. Because most liquid and reconstituted freeze-dried vaccines are susceptible to degradations, it may affect the immunological properties of the immunogens, with unwanted immune responses or insufficient immune protection.
For addressing liquid virosome-based vaccine instability and improving their shelf-life outside the cold chain, MACIVIVA will explore new galenic vaccine formulations through careful screening of excipients, stabilization and drying methods for generating new vaccine solid forms that can be easily self-administered. Robust “universal” manufacturing processes for upscale production of virosome dried powder for the non-invasive intranasal, oral and sublingual routes should be achieved.
http://www.maciviva.eu/

Open applications for the Translation Advisory Board

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Upcoming Events
NanoMedNorth Annual Event and Seminar 2017 May 31, 2017 10:00 AM - 04:00 PM — Gothenburg (Sweden)
EuroNanoForum 2017 Jun 21, 2017 - Jun 23, 2017 — Malta
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