Asunto(s)
Antígenos de Superficie/inmunología , Proteínas de la Membrana Bacteriana Externa/inmunología , Vacunas Bacterianas/inmunología , Lipoproteínas , Enfermedad de Lyme/prevención & control , Proteínas Recombinantes/inmunología , Antígenos de Superficie/genética , Antígenos de Superficie/metabolismo , Proteínas de la Membrana Bacteriana Externa/genética , Proteínas de la Membrana Bacteriana Externa/metabolismo , Vacunas Bacterianas/uso terapéutico , Grupo Borrelia Burgdorferi/citología , Ensayos Clínicos como Asunto , Humanos , Enfermedad de Lyme/microbiología , Proteínas Recombinantes/genética , Proteínas Recombinantes/metabolismoRESUMEN
Risk assessment for the deliberate release of microorganisms into the environment is traditionally carried out on a case-by-case basis. In a similar approach to that used when assessing human pathogenicity, we propose an alternative approach by introducing risk classes to facilitate or complement this type of risk assessment. These consider several sets of scenarios that address the different values that need to be protected. Examples of this approach include risk-class definitions for soil fertility and biodiversity.
Asunto(s)
Biotecnología/organización & administración , Biotecnología/normas , Contaminación Ambiental/prevención & control , Bacterias/clasificación , Bacterias/patogenicidad , Reactores Biológicos/efectos adversos , Reactores Biológicos/normas , Ecosistema , Europa (Continente) , Humanos , Microbiología/legislación & jurisprudencia , Medición de Riesgo/métodos , Medición de Riesgo/normas , Gestión de Riesgos , Contaminantes del Suelo/normas , Abastecimiento de Agua/normasRESUMEN
The transport of infectious and biological material is regulated by a number of international organizations. This mini-review has been compiled to increase awareness within the scientific community of problems caused by differences in terminology (such as infectious materials/substances, biological products, diagnostic specimens, genetically modified microorganisms) and certain technical aspects of the main international guidelines, and to assist policy makers in the creation of harmonized guidelines. A list of relevant Internet resources has been compiled.
Asunto(s)
Productos Biológicos , Infecciones/etiología , Transportes , Animales , Bacterias , Hongos , Guías como Asunto , Humanos , Cooperación Internacional , Parásitos , VirusRESUMEN
The current systems for classifying human pathogens on the basis of hazard are well developed and their basic criteria are in general agreement one with another. Of more importance, the safety practices based on these classifications have generally been successful. They have enabled extensive research activities, medical practice and industrial production to be conducted on an ever-increasing scale, involving dangerous microorganisms (e.g. in vaccine production and treatment of infected patients) with a very low incidence of adverse effects on the workers involved and the general public. Although the EU has adopted a harmonised list of agents in groups 1-4 there is as yet no complete agreement among member states and individual microbiologists. The purpose of this paper is to present a historical survey and to discuss the current processes for identifying and classifying the hazards posed by the use of microorganisms in research and technology. This is essential in the design of appropriate methods of counteracting potential risks.
Asunto(s)
Sustancias Peligrosas/clasificación , Administración de la Seguridad , Bacterias/clasificación , Historia del Siglo XX , Humanos , Microbiología/historia , Investigación , Administración de la Seguridad/historia , Virus/clasificación , Organización Mundial de la SaludRESUMEN
The assessment of microorganisms in respect to human health is an important step for the introduction of new natural and genetically modified production strains to biotechnology. This report outlines the potential hazards posed by industrial microorganisms, important considerations related to pathogenicity, such as routes and portals of entry into the human body, mechanisms of spread of biological material and a definition of pathogenicity. Furthermore the most important steps in the assessment of pathogenicity of unknown strains are described. A short overview on characterization and in vitro and in vivo tests is presented. The hazard related to allergens and toxic metabolites is reviewed and the choice of methods and the handling of strains with unknown potential are discussed.
Asunto(s)
Microbiología Industrial , Alérgenos , Animales , Humanos , VirulenciaRESUMEN
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.
Asunto(s)
Biotecnología , Células Cultivadas , Contención de Riesgos Biológicos , Técnicas de Cultivo/métodos , Guías como Asunto , Infección de Laboratorio/prevención & control , Seguridad , Grupos de Población Animal/microbiología , Animales , Bacterias/clasificación , Bacterias/aislamiento & purificación , Células Sanguíneas/microbiología , Células Cultivadas/microbiología , Contención de Riesgos Biológicos/métodos , Contención de Riesgos Biológicos/normas , Técnicas de Cultivo/normas , ADN Recombinante , Hongos/clasificación , Hongos/aislamiento & purificación , Humanos , Infección de Laboratorio/microbiología , Riesgo , Virus/clasificación , Virus/aislamiento & purificaciónRESUMEN
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.
Asunto(s)
Contención de Riesgos Biológicos , Plantas/microbiología , SeguridadRESUMEN
A new tetravalent meningococcal polysaccharide vaccine containing groups A, C, W 135, and Y was administered to 40 healthy adults. The vaccine was well tolerated and bactericidal assay showed mean titre increases for the meningococcal polysaccharide groups A, C, W 135, and Y of 5.0, 7.8, 8.2, and 5.9 log(2) titre steps, respectively. The immunogenicity and side-effects of the vaccine were similar to those associated with monovalent and bivalent vaccines containing group A and C meningococcal polysaccharides.
Asunto(s)
Vacunas Bacterianas/uso terapéutico , Meningitis Meningocócica/prevención & control , Neisseria meningitidis/inmunología , Adulto , Anticuerpos Antibacterianos/análisis , Vacunas Bacterianas/efectos adversos , Femenino , Humanos , Masculino , Polisacáridos Bacterianos/inmunologíaAsunto(s)
Vacunas Bacterianas , Meningitis Meningocócica/prevención & control , Neisseria meningitidis/inmunología , Adolescente , Adulto , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Meningitis Meningocócica/epidemiología , Persona de Mediana Edad , Neisseria meningitidis/aislamiento & purificación , RwandaRESUMEN
A new procedure is described for the quantitative extraction and determination of dimethyl polysiloxane by 1H-NMR spectroscopy, using tetrachloroethylene as the solvent and dioxane as the internal reference.