This release is available in German.
UK regulators have approved Europe's first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.
The trial will test the safety of a plant-derived antibody designed to stop the transmission of HIV between sexual partners when applied directly to the vaginal cavity. If proven safe in the 11 participants, the researchers can then go on to test the effectiveness of the product.
The clinical trial marks the culmination of the EU Framework 6 Pharma-Planta project, which was launched by a consortium of 30 academic and industrial partners in 2004 with 12 million in funding from the European Union. The primary goal was to develop an approved manufacturing process for recombinant pharmaceutical proteins made in plants and take one such product through all the development stages including the pivotal clinical trial.
Most biopharmaceuticals are currently made at great expense in fermentation vats containing bacteria or mammalian cells, but the mass production of medicines in genetically modified plants could reduce costs and therefore make an important contribution to global health, by improving access for the poor in developing countries where diseases such as HIV are a huge problem. In addition, the simple manufacturing process could be transferred to developing countries allowing production "in the region for the region".
The approval granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a significant step forwards because it means a plant-based production system can comply with current Good Manufacturing Practice
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| Contact: Dr. Rainer Fischer rainer.fischer@ime.fraunhofer.de 49-241-608-511-021 Fraunhofer-Gesellschaft Source:Eurekalert |
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