Assuntos
Segurança do Sangue/tendências , Doenças Transmissíveis Emergentes/sangue , Animais , Bancos de Sangue/organização & administração , Transfusão de Componentes Sanguíneos/efeitos adversos , Transfusão de Componentes Sanguíneos/métodos , Transfusão de Componentes Sanguíneos/normas , Transfusão de Componentes Sanguíneos/tendências , Segurança do Sangue/métodos , Segurança do Sangue/normas , Canadá/epidemiologia , Doenças Transmissíveis Emergentes/epidemiologia , Doenças Transmissíveis Emergentes/prevenção & controle , Doenças Transmissíveis Emergentes/transmissão , Congressos como Assunto , Seleção do Doador/métodos , Educação , Humanos , Setor Público , Cruz Vermelha/organização & administração , Medição de Risco , Inquéritos e Questionários , Estados Unidos/epidemiologia , United States Food and Drug Administration/organização & administraçãoRESUMO
In this paper the authors discuss the role of regulation in assuring blood safety. After an overview of the subject by a leading expert, examples are provided of regulatory systems for blood transfusion services in several countries and regions. Additionally, the perspective of WHO is given on the essential role of national regulatory authorities in assuring the quality of national blood programmes. Collectively, the sections of this paper afford an opportunity for readers to make comparisons among different regulatory frameworks and to "benchmark" among the existing systems. Despite many differences in approach, a clear pattern emerges of worldwide efforts to strengthen blood regulatory systems.
Assuntos
Transfusão de Sangue/legislação & jurisprudência , Regulamentação Governamental , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , África , Sudeste Asiático , Brasil , Canadá , Humanos , Agências Internacionais/legislação & jurisprudência , Irã (Geográfico) , Segurança , Reação Transfusional , Organização Mundial da SaúdeRESUMO
Production of recombinant subunit vaccines in transgenic plants may be a means of reducing vaccine costs while increasing availability and safety. A plant-derived product found safe and effective for oral administration would provide additional advantages when used as a vaccine. Outstanding issues with the technology include transgene stability through successive generations and consistent bioproduction. We previously reported expression of glycoprotein B (gB) of human cytomegalovirus in seeds of transgenic tobacco. Here the goal was to determine if gB could be similarly expressed in rice, and if so, to examine expression over several plant generations. Results show that immunoreactive gB was successfully expressed in transgenic rice seeds, with sustained expression over three generations. The gB contained several neutralizing epitopes and was stable over 27 months.
Assuntos
Homozigoto , Oryza/embriologia , Sementes/metabolismo , Proteínas do Envelope Viral/metabolismo , Southern Blotting , Ensaio de Imunoadsorção Enzimática , Plantas Geneticamente Modificadas , Reação em Cadeia da Polimerase , Proteínas Recombinantes/metabolismoRESUMO
The use of transgenic plants in the production of recombinant proteins for human therapy, including subunit vaccines, is being investigated to evaluate the efficacy and safety of these emerging biopharmaceutical products. We have previously shown that synthesis of recombinant glycoprotein B (gB) of human cytomegalovirus can be targeted to seeds of transgenic tobacco when directed by the rice glutelin 3 promoter, with gB retaining critical features of immunological reactivity (E.S. Tackaberry et al. 1999. Vaccine, 17: 3020-3029). Here, we report development of second generation transgenic plant lines (T1) homozygous for the transgene. Twenty progeny plants from two lines (A23T(1)-2 and A24T(1)-3) were grown underground in an environmentally contained mine shaft. Based on yields of gB in their seeds, the A23T(1)-2 line was then selected for scale-up in the same facility. Analyses of mature seeds by ELISA showedthat gB specific activity in A23T(1)-2 seeds was over 30-fold greater than the best T0 plants from the same transformation series, representing 1.07% total seed protein. These data demonstrate stable inheritance, an absence of transgene inactivation, and enhanced levels of gB expression in a homozygous second generation plant line. They also provide evidence for the suitability of using this environmentally secure facility to grow transgenic plants producing therapeutic biopharmaceuticals.