Keywords: Transgenic plants; plant-made pharmaceuticals; plantibodies; plantigens; vaccines; HIV; tuberculosis; rabies
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’.
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.
Pharma-Planta aims to build a plant-based production platform for pharmaceuticals in Europe and to enter the first candidates of this pipeline into phase I clinical trials. The project will develop robust risk-assessment and risk-management practices based on health and environmental impact, and will work with EU regulatory authorities to ensure safety and acceptance.
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. With this proposal, the primary aim is to build on previous proof-of-concept studies to develop a pharmaceutical product through to phase I clinical trials. The use of GM pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant-derived materials used in humans have not been formally addressed within the EU. A major outcome will, therefore, 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 to a clinical trial 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 also included will be neutralising antibodies for both HIV and rabies. The proposal also includes a limited range of other targets that 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 the principle aim of developing plant-derived recombinant pharmaceuticals, there is a recognised need to put in place comprehensive risk assessments based on health and environmental impacts, and to work with EU regulatory authorities to ensure that GM plant production systems are compliant with all biosafety regulations. An intellectual property management component will be incorporated to facilitate the availability of plant derived recombinant pharmaceuticals to the poor in developing countries, particularly in view of the fact that many of the priority molecular targets will have significant demand in these countries. This proposal is a unique opportunity to make an impact on EU and global health through the responsible development of plant biotechnology.
Pharma-Planta consortium partners represent many of the major laboratories in Europe focusing on the creation of transgenic plants that express important pharmaceuticals for human health. Collectively, the consortium has a wide range of expertise spanning the areas of molecular biology, plant biology, immunology, recombinant protein expression technology, vaccinology, plant biotechnology, risk assessment and IP management. Using commercially relevant molecules, the project brings together all of the state of the art technologies relevant to the production of recombinant pharmaceuticals in plants.
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V
c/o RWTH Aachen
Tel: +49 241 8026631
Fax: +49 241 871062
Project Manager: Richard M. Twyman
Department of Biology
University of York
YO10 5DD York
Tel: +44 1430 872694
Fax: +44 1430 872694