UK Starts Trial for Plant-produced Monoclonal Antibody

The mass production of medicines in genetically modified plants could reduce costs and improve access to drugs in developing countries where diseases such as HIV are a huge problem.

Clinical trials for a monoclonal antibody produced in genetically modified tobacco plants have begun in the UK. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first trial in Europe, which means a plant-based production system can comply with Good Manufacturing Practice.

The clinical trial, which is taking place at the University of Surrey Clinical Research Centre, will test a topically applied anti-HIV microbicide. The 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 €12m of EU funding. 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