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Genetically modified organisms

GlaxoSmithKline is in the forefront of the development and application of new scientific techniques to discover and develop new medicines and vaccines. We routinely use genetically modified organisms (GMOs) in the research and discovery of new therapeutic agents and also in the efficient manufacture of certain medical products such as vaccines.

Research & development operations use GMOs in a wide range of laboratory activities in our work to discover and develop new medicines. More specifically, they are used to identify the genetic targets and causes of disease, and to develop new drugs for conditions such as heart disease, diabetes and depression, as well as antibiotics. We use a number of different GMOs, predominantly harmless organisms such as disabled strains of the bacterium E.coli and eukaryotic cells in culture.

All work with GMOs within GlaxoSmithKline is controlled to the strictest national and international regulations, and we apply best practice across all our facilities. Any work with GMOs is subject to full risk assessment including safe conditions of use, storage and disposal. Any laboratory work with GMOs is performed under conditions of contained use, using containment laboratories appropriate to the risk of the materials handled. The large-scale fermentation or propagation of GMOs in research & development is always undertaken in fully contained systems. All processes are performed in closed vessels minimising the risk of release, in line with existing legislation and best practice. All work is controlled by written procedures, and regular maintenance checks ensure the processes are operated to the necessary level of contained use.

We also manufacture a number of products that are derived from genetically modified materials, such as Hepatitis B vaccine. GMOs are sometimes used as intermediates in the manufacturing process of medicines such as antibiotics, but GlaxoSmithKline does not produce any products that are or contain viable organisms. We have no plans to introduce products that are live GMO's for the foreseeable future. All manufacturing processes also operate under conditions of contained use to prevent the release of any GMOs to the environment.

GlaxoSmithKline has a policy of routinely treating all waste from our GMO operations, to ensure we do not release viable GMOs from our contained processes into the environment. As a result, all GMOs are inactivated prior to disposal by chemical or heat treatment.

We do not routinely undertake research & development involving the cultivation of genetically modified plant species. However, one exception was a small-scale field trial undertaken in Australia to develop morphine-containing medicines, which are only available on prescription from a doctor. Research was focused on increasing the yield of alkaloids in poppies with enhanced properties to develop more effective pain management medicines. The Australian government strictly controlled these small-scale trials. These trials have now been completed, and there are no plans at this stage to move to large scale production of GM poppies.

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