RESUMO
The benefits of using animal or human cell cultures have been clearly demonstrated in diagnostic and therapeutic research and in their application for manufacturing. Cell cultures serve as a tools for the production of vaccines, receptors, enzymes, monoclonal antibodies and recombinant DNA-derived proteins. They represent an integral part of drug development for which corresponding facilities, equipment and manufacturing processes are required. Although the cells themselves offer no particular risk to workers in laboratories and production areas or to the environment, the cell cultures may be contaminated with viruses, mycoplasma, bacteria, yeast and fungi or might contain endogenous viruses. The containment level for animal and human cells is therefore determined by the risk class of these agents. The history of animal and human cell cultures has proved that they can be handled safely. The recommendations in this publication concern the safe handling of cell cultures (tissue explants, primary cell cultures) and permanent cell lines of animal and human origin. A classification system of safety precautions has been elaborated according to the potential for contamination with the pathogenic agents involved.
Assuntos
Biotecnologia , Células Cultivadas , Contenção de Riscos Biológicos , Técnicas de Cultura/métodos , Guias como Assunto , Infecção Laboratorial/prevenção & controle , Segurança , Grupos de População Animal/microbiologia , Animais , Bactérias/classificação , Bactérias/isolamento & purificação , Células Sanguíneas/microbiologia , Células Cultivadas/microbiologia , Contenção de Riscos Biológicos/métodos , Contenção de Riscos Biológicos/normas , Técnicas de Cultura/normas , DNA Recombinante , Fungos/classificação , Fungos/isolamento & purificação , Humanos , Infecção Laboratorial/microbiologia , Risco , Vírus/classificação , Vírus/isolamento & purificaçãoRESUMO
The Working Party on Safety in Biotechnology of the European Federation of Biotechnology has proposed a classification of microorganisms that cause diseases in plants. In this paper appropriate safety levels are proposed for these classes of microorganisms in order to ensure that research, development and industrial fermentation work with plant pathogens will limit the risk of outbreaks of diseases in crops that could result from work with such microorganisms when they are cultivated in laboratories, glasshouses and biotechnology installations.
