[Recent advances in understanding and diagnosing hepatitis B virus infection]. / Progrès récents dans la compréhension et le diagnostic de l'infection chronique par le virus de l'hépatite B.

Hepatitis B virus (HBV) infects approximately 257 million individuals worldwide. Recent advances in the virology and diagnosis of HBV infection are summarized in this review article. A novel classification of the different phases of chronic HBV infection, proposed by the European Association for the Study of the Liver (EASL), is presented. New diagnostic and monitoring tools are now available, including rapid diagnostic tests for hepatitis B surface antigen (HBsAg) detection, HBsAg quantification assays, an HBV core-related antigen (HBcrAg) quantification test, and HBV RNA quantification testing. Their clinical utility under study is discussed in this review.

A guide to the contained use of plant virus infectious clones.

Plant virus infectious clones are important tools with wide-ranging applications in different areas of biology and medicine. Their uses in plant pathology include the study of plant-virus interactions, and screening of germplasm as part of prebreeding programmes for virus resistance. They can also be modified to induce transient plant gene silencing (Virus Induced Gene Silencing - VIGS) and as expression vectors for plant or exogenous proteins, with applications in both plant pathology and more generally for the study of plant gene function. Plant viruses are also increasingly being investigated as expression vectors for in planta production of pharmaceutical products, known as molecular farming. However, plant virus infectious clones may pose a risk to the environment due to their ability to reconstitute fully functional, transmissible viruses. These risks arise from both their inherent pathogenicity and the effect of any introduced genetic modifications. Effective containment measures are therefore required. There has been no single comprehensive review of the biosafety considerations for the contained use of genetically modified plant viruses, despite their increasing importance across many biological fields. This review therefore explores the biosafety considerations for working with genetically modified plant viruses in contained environments, with focus on plant growth facilities. It includes regulatory frameworks, risk assessment, assignment of biosafety levels, facility features and working practices. The review is based on international guidance together with information provided by plant virus researchers.

Recently Patented Viral Nucleotide Sequences and Generation of Virus-Derived Vaccines.

BACKGROUND: With an increase in comprehension of the molecular biology of viruses, there has been a recent surge in the application of virus sequences and viral gene expression strategies towards the diagnosis and treatment of diseases. RESULTS: The scope of the patenting landscape has widened as a result and the current review discusses patents pertaining to live / attenuated viral vaccines. The vaccines addressed here have been developed by both conventional means as well as by the state-of-the-art genetic engineering techniques. CONCLUSION: This review also addresses the applications of these patents for clinical and biotechnological purposes.

Meeting Report: 2013 PDA Virus & TSE Safety Forum.

The report provides a summary of the presentations and discussions at the Virus & TSE Safety Forum 2013 organized by the Parenteral Drug Association (PDA) and held in Berlin, Germany, from June 4 to 6, 2013. The conference was accompanied by a workshop, "Virus Spike Preparations and Virus Removal by Filtration: New Trends and Developments". The presentations and the discussion at the workshop are summarized in a separate report that will be published in this issue of the journal as well. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2013 provided again an excellent opportunity to exchange information and opinions between the industry, research organizations, and regulatory bodies. Updates on regulatory considerations related to virus and transmissible spongiform encephalopathy (TSE) safety of biopharmaceuticals were provided by agencies of the European Union (EU), the United States (US), and Singapore. The epidemiology and detection methods of new emerging pathogens like hepatitis E virus and parvovirus (PARV 4) were exemplified, and the risk of contamination of animal-derived raw materials like trypsin was considered in particular. The benefit of using new sequence-based virus detection methods was discussed. Events of bioreactor contaminations in the past drew the attention to root cause investigations and preventive actions, which were illustrated by several examples. Virus clearance data of specific unit operations were provided; the discussion focused on the mechanism of virus clearance and on the strategic concept of viral clearance integration. As in previous years, the virus safety section was followed by a TSE section that covered recent scientific findings that may influence the risk assessment of blood and cell substrates. These included the realization that interspecies transmission of TSE by blood components in sheep is greater than predicted by assays in transgenic mice. Also, the pathogenesis and possibility of productive TSE infection of cell substrates were considered, and cell-based assays that may be suitable for use in TSE clearance studies were discussed. The current report provides an overview about the outcomes of the 2013 PDA Virus & TSE Safety Forum, a unique event in this field.

Medical devices; immunology and microbiology devices; classification of reagents for detection of specific novel influenza A viruses. Final rule.

The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, "Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses" and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.

Prevention of the Xenogenic Infection Risk and the Spanish and German Constitutions

Si el problema de una infección xenogénica o de una posterior xenozoonosis es probablemente el obstáculo más importante en el camino de un xenotrasplante terapéuticamente aceptable en su salto a su aplicación clínica, es por lo mismo fundamental evaluar Ias posibilidades que ofrece el Derecho para atajar tal riesgo. Este artículo tratará de ofrecer un marco de Ias soluciones preventivas - es decir, tras la operación y antes de la aparición de pruebas inequívocas de infección xenogénica - que sean posibles desde los ámbitos constitucionales de los sistemas jurídicos alemán y español. Principalmente en cuanto a sus dos propuestas más representativas: la posibilidad de experimentar y mantener a los animales fuente de los injertos en condiciones especial y específicamente higiénicas, así como la eventualidad de obligar al paciente (y/o a sus contactos íntimos o próximos) a observar ciertas medidas profilácticas, en tal fase temprana de riesgo, con el fin de prevenir la expansión de una posible xenoenfermedad a terceros (AU)

No disponible

El status moral de los animales en la discusión sobre xenotrasplantes (parte II) / The moral status of animals in the discussions on xenotransplantation (Part II)

No disponible

No disponible

[The creation and functions of the Depository of Microorganism Strains in the Institute of Microbiology and Virology of the National Academy of Sciences of Ukraine]. / Stvorennia ta funktsii depozytariiu shtamiv mikroorhanizmiv Instytutu mikrobiolohiï i virusolohiï NAN Ukraïny.

The legislative and other standard acts regulating the functioning of the home depositories and the procedure of microorganism strains deposition when patenting the inventions in Ukraine have been developed and came in force. The depository created on the basis of the Institute of Microbiology and Virology of the National Academy of Sciences of Ukraine to deposit nonpathogenic strains of microorganisms and to execute a number of service works in the field of microbiology and biotechnology began its activities (investigation, identification, certification, preservation of cultures, development of the methods of long-term preservation, toxico-biological evaluation of producers, delivery of strains, consultations, obtaining of information materials).