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

Objective

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.

Field of science

  • /medical and health sciences/medical biotechnology/nanomedicine

Call for proposal

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

Funding Scheme

RIA - Research and Innovation action

Coordinator

MIDATECH PHARMA ESPANA SL
Address
Parque Tecnologico De Bizkaia Edificio 800 2A Planta
48160 Derio
Spain
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 2 516 593,75

Participants (9)

CENTRE FOR PROCESS INNOVATION LIMITED LBG
United Kingdom
EU contribution
€ 2 080 420,50
Address
Wilton Centre Wilton
TS10 4RF Redcar Cleveland
Activity type
Research Organisations
PROCHIMIA SURFACES SP. Z O.O.
Poland
EU contribution
€ 472 875
Address
Zacisze 2
81823 Sopot
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GALCHIMIA SA
Spain
EU contribution
€ 675 553,75
Address
Lugar De Cebreiro Sn
15823 O Pino A Coruna
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MIDATECH LTD
United Kingdom
EU contribution
€ 866 958,75
Address
Oddfellows House 19 Newport Road
CF24 0AA Cardiff
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland
EU contribution
€ 612 921
Address
Belfield
4 Dublin
Activity type
Higher or Secondary Education Establishments
LGAI TECHNOLOGICAL CENTER SA
Spain
EU contribution
€ 409 708,75
Address
Ronda De La Font Del Carme Sn Bellaterra Campus De La Universitat Autonoma De Barcelona
08193 Cerdanyola Del Valles Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IFOM FONDAZIONE ISTITUTO FIRC DI ONCOLOGIA MOLECOLARE

Participation ended

Italy
EU contribution
€ 76 618,41
Address
Via Adamello 16
20139 Milano
Activity type
Research Organisations
ECOLE POLYTECHNIQUE FEDERALE DE LAUSANNE
Switzerland
EU contribution
€ 0
Address
Batiment Ce 3316 Station 1
1015 Lausanne
Activity type
Higher or Secondary Education Establishments
"INSTITUTO TUMORI ""GIOVANNI PAOLO II"""
Italy
EU contribution
€ 187 131,59
Address
Via Orazio Flacco 65
70126 Bari
Activity type
Research Organisations