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EC-sponsored Research on Safety of Genetically Modified Organisms - A Review of Results
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imageimageimage Plant  microbes
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image Assessment of environmental risks and containment of biotechnological scaled-up processes

Background and objectives

The introduction of recombinant DNA techniques into large-scale bioprocessing has raised safety concerns, and in particular those about the risks of exposure of the operator and environment. Public perception of this risk is preventing more rapid adoption of recombinant DNA bioprocesses. The most common form of occupational exposure is from air via the respiratory route into the lungs. Although the micro-organisms used in the majority of biotechnological processes are unlikely to be pathogenic in themselves, the molecules they produce or express may in some cases present a health risk if the micro-organism is able to colonise the body following inhalation.

Approach and methodology

Technical information about bioprocessing safety is an integral part of the developing regulatory framework in biotechnology. A review of risks associated with bioprocessing revealed equipment and processing operations where problems might occur. The project developed and used methods to assess risk and containment for selected unit operations and components

Main findings and outcome

The evaluation of risks in biotechnology is far more difficult than that for the chemical industry. This is mainly due to the lack of reliability of data and gaps in knowledge about fundamental mechanisms underlying the properties of fugitive micro-organisms and their products. Various methods involving the use of aerobiological samplers and particle monitors were applied to containment testing of bioprocess unit operations. The project identified the need for rapid and sensitive methods for detecting breaches of containment. Indeed, tests carried out during the project identified difficulties with fermenter off-gas filters, cell disrupters, and a continuous centrifuge


The application of a biochemical method, the ATP assay, to aerobiology was found to be particularly effective for the rapid determination of microbiological emissions from equipment. The fermenter air filtration test apparatus was acknowledged by industrialists to be an excellent design which addressed many of the problems limiting previous research work in the field and the testing procedure has recently (2000) been submitted to EHEDG (European Hygienic Equipment Design Group) to become a standard.

Major publications

Kastelein J., Deans J.S., Logtenberg M.T., Hesselink P.G.M., Stewart I.W., “Risk Assessment in Industrial Biotechnology”.
Agro-Industry Hi-Tech, May 1992, pp. 26-28.

Hesselink P.G.M., Kastelein J. and Logtenberg M.T., “Biosafety Aspects of Biotechnological Processes; Testing and Evaluating Equipment and Components”, in Fermentation Technologies: Industrial Applications, edited by Pak-Lam YU, Department of Biotechnology, Massey University, Palmerston North, New Zealand, Elesevier Applied Science, London and New York.

Kastelein J., Logtenberg M.T. and Hesselink P.G.M., “Testing and Evaluation of off-gas filters for bioreactors by a new bacterial aerosol challenge test method (TBAC)”.
Enzyme Microb. Technol., 1992, vol. 14 July, pp. 553-560.
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Contract number

June 1986 – December 1989



M.T. Logtenberg
TNO Environment, Energy and Process Innovation
Apeldoorn (NL)

I.W. Stewart
AEA Technology
Didcot (UK)

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