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PHARMA-PLANTA


HIV/AIDS, Tuberculosis

Recombinant Pharmaceuticals from Plants for Human Health
Framework programme:
6
Call:
1
Project number:
LSHB-CT-2003-503565
EC contribution:
€ 12,000,000
Duration:
60 months
Type:
IP
Starting date:
1 February 2004

Keywords: Transgenic plants; plant-made pharmaceuticals; plantibodies; plantigens; vaccines; HIV; tuberculosis; rabies

Summary:

The Pharma-Planta project is a consortium of 39 principal investigators from institutions including SMEs in Europe and Africa. Pharma-Planta has been funded by the European Commission as part of the Sixth Framework Programme in the area of ‘Plant platforms for immunotherapeutic biomolecule production’.

Background:

The expression of recombinant pharmaceutical proteins in plants has been under investigation for over ten years. Plants are attractive for several reasons, but the primary advantages are that they represent an inexpensive and versatile expression system for a wide variety of recombinant proteins, and they offer the potential for rapid and economical scale-up. EU funding through the Fourth and Fifth Framework Programmes (FP4 and FP5) has been a major driver in this area. Pharma-Planta is an EU FP4 project, which aims to move beyond proof-of-concept studies and develop candidate products for clinical evaluation in phase I human trials. This will include compliance with all regulatory requirements, good manufacturing practice (GMP) standards and pre-clinical toxicity testing. The consortium will also develop robust risk assessment practices for recombinant pharmaceutical molecules produced in plants, based on health and environmental impact, working closely with the appropriate regulatory authorities. Finally, the consortium will develop a coordinated programme for securing and managing intellectual property, which will facilitate the availability of high priority, plant-derived recombinant pharmaceuticals to the poor in developing countries.

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