The Pharma-Planta Consortium comprises 33 academic and industry partners in Europe and South Africa. The Pharma-Planta project was funded by the European Commission as part of the Sixth Framework Programme in the area of "Plant platforms for immunotherapeutic biomolecule production" and was originally intended toi run from 2004 to 2009. Because the development of a new regulatory pathway for plant-derived pharmaceuticals has been very time consuming, the project will now end in October 2011.
Pharma-Planta aimed to build a plant based production platform for pharmaceuticals in Europe and to enter the first candidate pharmaceuticals into human clinical trials, a feat that was achieved in June 2011. The programme has developed robust risk-assessment and risk-management practices based on health and environmental impact, and worked with EU regulatory authorities such as EMA and EFSA to deal with issues surrounding safety and acceptance.
Plants have enormous potential for the production of recombinant pharmaceutical proteins as they are inexpensive and versatile, amenable to rapid and economical scale-up. The use of GM for the production of 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. Our major goal was to address the necessary biosafety and regulatory requirements for the use of plant derived pharmaceuticals through a process of engagement and consultation with regulatory bodies involved in GM plants as well as new medicines. The project addresses pharmaceuticals for the prevention of HIV, rabies, tuberculosis and diabetes, that remain significant health problems both in Europe and the developing world.
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. This project provides a unique opportunity to make an impact on EU and global health through the responsible development of plant biotechnology.