RESUMEN
This paper reviews some of the issues relevant to the effect of oncogene or recombinant DNAs in both in vivo and in vitro models. Many studies of directly injected DNAs alone, with mediators of DNA uptake, or as the initiator in a multi-stage tumor progression model, showed that the DNAs were only rarely (if at all) tumorigenic. Conclusions from these and other in vitro experiments were that single oncogenes transfected into human cells did not generally convert those cells to a malignant phenotype, suggesting that additional genetic insult(s) or other factors were needed. These data, in concert with other observations and standard methods for product purification, imply that recombinant DNAs or oncogenes in cell lines pose little or no risk in the production of biologicals.
Asunto(s)
Biotecnología/métodos , ADN Recombinante/normas , Vectores Genéticos , Transfección/métodos , Transformación Genética , Animales , Biotecnología/normas , Transformación Celular Neoplásica , Células Cultivadas , Humanos , Neoplasias Experimentales/genética , Proteínas Recombinantes/biosíntesis , Virus 40 de los Simios/genéticaRESUMEN
The scepticism about the future utility of newer biologicals towards reducing disease morbidity or mortality at the public health or application level can be regarded as appropriate. The financial or research inputs into producing anti-idiotypic, subunit, cloned or genetically engineered products may not be transcribed to the field level due to political or economic impediments and the putative breakdown of any specific activity at the application level, as with the conventional immunobiologicals, may also negate the utility of the newer products. Such an eventuality should be overcome by planning, during the pre-licensure phase, appropriate accelerated degradation tests on newer biologicals.
Asunto(s)
ADN Recombinante/normas , Evaluación Preclínica de Medicamentos/normas , Estabilidad de MedicamentosAsunto(s)
ADN Recombinante/biosíntesis , Pediatría , Animales , Clonación Molecular/métodos , Replicación del ADN , ADN Recombinante/normas , Electroforesis en Gel de Agar/métodos , Ética Médica , Código Genético , Humanos , Insulina/biosíntesis , Ratones , Plásmidos , Biosíntesis de Proteínas , Seguridad , beta-Galactosidasa/biosíntesisAsunto(s)
ADN Recombinante , Ética Médica , Tecnología , ADN Recombinante/normas , Humanos , Modelos Biológicos , Tecnología/normasAsunto(s)
ADN Recombinante/normas , Gobierno Federal , Regulación Gubernamental , ADN Viral/genética , Escherichia coli/genética , Escherichia coli/patogenicidad , National Institutes of Health (U.S.) , Proyectos de Investigación/normas , Medición de Riesgo , Estados Unidos , United States Dept. of Health and Human ServicesAsunto(s)
ADN Recombinante/normas , Medición de Riesgo , ADN Recombinante/efectos adversos , Maryland , RiesgoRESUMEN
This article summarizes the rationale behind the design of standardized laboratory tests for certification of bacteriophage lambda EK-2 vector systems. A discussion and description of the six vector systems which have been certified by the U.S. National Institutes of Health are also included. An appendix describes the officially approved laboratory tests in detail.