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

Project information

Grant agreement ID: 646142

  • Start date

    1 January 2015

  • End date

    30 June 2019

Funded under:

H2020-EU.2.1.2.1.

  • Overall budget:

    € 6 352 003

  • EU contribution

    € 6 283 988,75

Coordinated by:

FUNDACION CIDETEC

Spain

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.

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

UNIVERSIDAD DE SANTIAGO DE COMPOSTELA

Spain

EU Contribution

€ 273 500

SYLENTIS SAU

Spain

EU Contribution

€ 643 118,75

IX-FACTORY GMBH

Germany

EU Contribution

€ 84 973,21

CHEMTRIX BV

Netherlands

EU Contribution

€ 586 450

MEJORAN LAB AUTOMATION SL

Spain

EU Contribution

€ 981 662,50

SPINVERSE OY

Finland

EU Contribution

€ 198 441,25

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

MICRONIT GMBH

Germany

EU Contribution

€ 268 033,04

Project information

Grant agreement ID: 646142

  • Start date

    1 January 2015

  • End date

    30 June 2019

Funded under:

H2020-EU.2.1.2.1.

  • Overall budget:

    € 6 352 003

  • EU contribution

    € 6 283 988,75

Coordinated by:

FUNDACION CIDETEC

Spain

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