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A Pilot Plant for the Production of Polymer based Nanopharmaceuticals in Compliance with GMP

Objective

The aim of NanoPilot will be to set-up a flexible and adaptable pilot plant operating under GMP for the production of small batches of polymer-based nanopharmaceuticals, which exhibit significant potential in the field of drug-delivery particularly for the design of second-generation nanopharmaceuticals.
Three different processes will be established for the production of three different nanopharmaceuticals selected on the basis of their TRL and positive commercial evaluation: a) topical treatment of ocular pain associated with dry eye syndrome containing short interfering RNA and lactic acid, b) A resuspendable HIV nanovaccine for intranasal vaccination containing 12 peptides in its formulation. c) Hyaluronan based hollow spheres intended for intravesical instillation, for the treatment of interstitial cystitis/painful bladder syndrome.
State of the art production processes including micro reactors and highly advanced characterization techniques will ensure the quality of the nanodrugs. Existing laboratories suitable for large-scale production of biologics in compliance with GMP, and owned by the coordinator, will be adapted and certified within this project to enable the operability of the pilot plant.
NanoPilot consists of nine complementary partners composed by 1 Industry and 2 academia developers of the nanosystems to scale-up. A research Institute expert in nanoparticle characterizacion and already operating in compliance with Good laboratory practices. An SME and an Industry that will develop ad-hoc continuous flow reactors for the optimization of two of the three processes. A consultancy (SME) expert in Quality system implementation and laboratory information management systems. A second consultancy (SME) in charge of the business plan, that will also help the coordinator in dissemination and exploitation activities. Finally, a research centre with a recorded track in nanomedicine, already operating under ISO 9001, and will be in charge of the pilot plant.

Field of science

  • /social sciences/economics and business
  • /medical and health sciences/medical biotechnology/nanomedicine
  • /social sciences/economics and business/economics/production economics

Call for proposal

H2020-NMP-PILOTS-2014
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

FUNDACION CIDETEC
Address
Paseo Miramon 196 Parque Tecnologico De Miramon
20014 San Sebastian
Spain
Activity type
Research Organisations
EU contribution
€ 2 045 560

Participants (9)

NATIONAL UNIVERSITY OF IRELAND GALWAY
Ireland
EU contribution
€ 531 500
Address
University Road
H91 Galway
Activity type
Higher or Secondary Education Establishments
UNIVERSIDAD DE SANTIAGO DE COMPOSTELA
Spain
EU contribution
€ 273 500
Address
Colexio De San Xerome Praza Do Obradoiro S/n
15782 Santiago De Compostela
Activity type
Higher or Secondary Education Establishments
SYLENTIS SAU
Spain
EU contribution
€ 643 118,75
Address
Plaza Descubridor Diego De Ordas 3
28003 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IX-FACTORY GMBH

Participation ended

Germany
EU contribution
€ 84 973,21
Address
Konrad Adenauer Allee 11
44263 Dortmund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CHEMTRIX BV
Netherlands
EU contribution
€ 586 450
Address
Urmonderbaan 22
6167 RD Geleen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MEJORAN LAB AUTOMATION SL
Spain
EU contribution
€ 981 662,50
Address
Calle Agustin Querol 8
28014 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SPINVERSE OY
Finland
EU contribution
€ 198 441,25
Address
Tekniikantie 14
02150 Espoo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSOCIATION POUR LE DEVELOPPEMENT DE L'ENSEIGNEMENT ET DES RECHERCHES AUPRES DES UNIVERSITES, DES CENTRES DE RECHERCHE ET DES ENTREPRISES D'AQUITAINE
France
EU contribution
€ 670 750
Address
Avenue Du Docteur Albert Schweitzer - Centre Condorcet 162
33608 Pessac
Activity type
Research Organisations
MICRONIT GMBH
Germany
EU contribution
€ 268 033,04
Address
Konrad-adenauer-allee 11
44263 Dortmund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)