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Recombinant Pharmaceuticals from Plants for Human Health

Recombinant Pharmaceuticals from Plants for Human Health

Objective

Plants are attractive vehicles for the expression of recombinant pharmaceutical proteins as they are inexpensive and versatile systems, amenable to rapid and economical scale-up. Public opinion in Europe is generally negative towards GM plants, which has led to the loss of many SMEs and commercial development from the Union. However, the use of GM plants for medicines and vaccines rates very highly in terms of public acceptance. With this proposal, our primary aim is to build on previous proof-of-concept studies to develop pharmaceutical products through to clinical trials. The use of GM pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant-derived materials used in humans has not been formally addressed within the EU. A major outcome will be to define the regulatory requirements through a process of engagement and consultation with all relevant regulatory bodies (involved in GM plants as well as new pharmaceuticals), in order to move through clinical trials and gain permission for the use of plant derived pharmaceuticals in practice. Monoclonal antibodies will be the first generation of molecules to be developed for Phase I clinical evaluation, and we include 2 neutralising antibodies each for HIV and rabies. The proposal also includes a limited range of other targets, against HIV, TB and diabetes, and for some of these, new expression strategies will need to be developed. They represent the second-generation molecules, which will feed the development pipeline for SMEs in Europe, beyond the lifetime of the project. In each case, plant-based systems offer a real advantage, if not the only option for production on a scale relevant to the needs for that molecule. Alongside our principle aim of developing plant derived recombinant pharmaceuticals, we recognise the need to put in place comprehensive risk assessments based on health and environmental impacts, and to work with EU regulatory authorities.

Coordinator

FRAUNHOFER-GESELLSCHAFT ZUR FÖRDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Address

Hansastrasse 27c
MÜNchen

Germany

Administrative Contact

Stefan SCHILLBERG (Dr)

Participants (31)

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ST. GEORGE'S HOSPITAL MEDICAL SCHOOL'

United Kingdom

RHEINISCH-WESTFÄLISCHE TECHNISCHE HOCHSCHULE

Germany

NATIONAL UNIVERSITY OF IRELAND, MAYNOOTH

Ireland

JOHN INNES CENTRE

United Kingdom

CENTRE DE COOPÉRATION INTERNATIONALE EN RECHERCHE AGRONOMIQUE POUR LE DÉVELOPPEMENT

France

OXFORD BROOKES UNIVERSITY

United Kingdom

UNIVERSITY OF WARWICK

United Kingdom

UNIVERSITÄT FÜR BODENKULTUR

Austria

POLYMUN SCIENTIFIC IMMUNBIOLOGISCHE FORSCHUNG GMBH

Austria

UNIVERSITA' DEGLI STUDI DI VERONA

Italy

ENTE PER LE NUOVE TECHOLOGIE, L'ENERGIA E L'AMBIENTE'

Italy

UNIVERSITÉ BLAISE PASCAL - CLERMONT-FERRAND II

France

INSTITUT NATIONAL DE LA RECHERCHE AGRONOMIQUE

France

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE

United Kingdom

UNIVERSITY OF GLASGOW

United Kingdom

RUPRECHT-KARLS-UNIVERSITÄT HEIDELBERG

Germany

UNIVERSITÉ CATHOLIQUE DE LOUVAIN

Belgium

UNIVERSITY OF LEEDS

United Kingdom

CONSIGLIO NAZIONALE DELLE RICERCHE

Italy

COUNCIL FOR SCIENTIFIC AND INDUSTRIAL RESEARCH

South Africa

ROTHAMSTED RESEARCH

United Kingdom

UNIVERSITÉ DE NEUCHÂTEL

Switzerland

MAX-PLANCK-SOCIETY FOR THE ADVANCEMENT OF SCIENCE

Germany

THE PROVOST, FELLOWS AND SCHOLARS OF THE COLLEGE OF THE HOLY AND UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN ( HEREINAFTER CALLED TCD)

Ireland

INSTITUT FÜR PFLANZENGENETIK UND KULTURPFLANZENFORSCHUNG GATERSLEBEN

Germany

FLANDERS INTERUNIVERSITY INSTITUTE FOR BIOTECHNOLOGY

Belgium

CENTRE FOR THE MANAGEMENT OF INTELLECTUAL PROPERTY IN HEALTH REARARCH AND DEVELOPMENT

United Kingdom

MOSAIC SYSTEMS BV

Netherlands

UNIVERSITAT DE LLEIDA

Spain

SARTORIUS AG

Germany

THE UNIVERSITY OF SURREY

United Kingdom

Project information

Grant agreement ID: 503565

  • Start date

    1 February 2004

  • End date

    31 October 2011

Funded under:

FP6-LIFESCIHEALTH

  • Overall budget:

    € 17 575 968

  • EU contribution

    € 11 972 714

Coordinated by:

FRAUNHOFER-GESELLSCHAFT ZUR FÖRDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany