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The Development of Medium- and Large-Scale Sustainable Manufacturing Process Platforms for Clinically Compliant Solid Core Nanopharmaceuticals

Obiettivo

A number of nanomedicine formulations have enabled, or been shown to hold considerable potential for enabling more effective and less toxic therapeutic interventions. However, progress to date in translating these initiatives to commercial success has been limited. One of the main reasons for this bottleneck is due to the inability of researchers and stakeholders to manufacture batches of the nanomedicine product at the required scale and according to Good Manufacturing Practice (GMP) requirements. The NANOFACTURING project will focus on
- facilitating access to required infrastructures and expertise
- creating GMP pilot lines for up-scaling manufacturing
- addressing the current developmental and production gaps
- taking nanomaterials already successfully produced at proof-of-concept/milligram levels and facilitating their scale-up to sub-kilogram quantities
- providing large-scale and GMP production for clinical trials and nanomedicine translation.
The NANOFACTURING project, through a consortium of 9 partners, will develop the synthetic processes, process control methods, analytical assays for QA/QC, functional specifications, and best practices, interfacing existing R&D centres of excellence, transfer organisations and private GMP manufacturing facilities (including SMEs) to ensure efficient translation from discovery through to first in man, proof-of-concept studies and beyond to Phase III according to industrial and regulatory standards. Specifically, the NANOFACTURING project aims to create a platform process for early, mid- and large-scale manufacturing of glycan-coated gold nanoparticles (GNPs), a widely researched and developed class of self-forming nanoparticles. The ability to engineer new nanopharmaceuticals based on this patent protected platform technology, developed by Midatech Biogune S.L. (Project Coordinator), will have inherent advantages over existing treatments for multiple therapeutic areas.

Invito a presentare proposte

H2020-NMP-PILOTS-2014
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Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

MIDATECH PHARMA ESPANA SL
Indirizzo
Parque Tecnologico De Bizkaia Edificio 800 2A Planta
48160 Derio
Spagna
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contributo UE
€ 2 516 593,75

Partecipanti (9)

CENTRE FOR PROCESS INNOVATION LIMITED LBG
United Kingdom
Contributo UE
€ 2 080 420,50
Indirizzo
Wilton Centre Wilton
TS10 4RF Redcar Cleveland
Tipo di attività
Research Organisations
PROCHIMIA SURFACES SP. Z O.O.
Polonia
Contributo UE
€ 472 875
Indirizzo
Zacisze 2
81823 Sopot
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GALCHIMIA SA
Spagna
Contributo UE
€ 675 553,75
Indirizzo
Parque Empresarial De Touro Parcela 26-27 Fonte Diaz
15822 Touro A Coruna
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MIDATECH LTD
United Kingdom
Contributo UE
€ 866 958,75
Indirizzo
Oddfellows House 19 Newport Road
CF24 0AA Cardiff
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Irlanda
Contributo UE
€ 612 921
Indirizzo
Belfield
4 Dublin
Tipo di attività
Higher or Secondary Education Establishments
LGAI TECHNOLOGICAL CENTER SA
Spagna
Contributo UE
€ 409 708,75
Indirizzo
Ronda De La Font Del Carme Sn Bellaterra Campus De La Universitat Autonoma De Barcelona
08193 Cerdanyola Del Valles Barcelona
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IFOM FONDAZIONE ISTITUTO FIRC DI ONCOLOGIA MOLECOLARE

Partecipazione conclusa

Italia
Contributo UE
€ 76 618,41
Indirizzo
Via Adamello 16
20139 Milano
Tipo di attività
Research Organisations
ECOLE POLYTECHNIQUE FEDERALE DE LAUSANNE
Svizzera
Contributo UE
€ 0
Indirizzo
Batiment Ce 3316 Station 1
1015 Lausanne
Tipo di attività
Higher or Secondary Education Establishments
"INSTITUTO TUMORI ""GIOVANNI PAOLO II"""
Italia
Contributo UE
€ 187 131,59
Indirizzo
Via Orazio Flacco 65
70126 Bari
Tipo di attività
Research Organisations