Developments in biologicals (Dev Biologicals )

Publisher: International Association for Biologicals, Karger

Description

The International Association for Biologicals (formerly the International Association of Biological Standardization) organizes international meetings which confront the numerous practical problems involved in standardization and bring together researchers, manufacturers, public health authorities and government officials. Books in this series, which record these meetings, are respected as definitive references to current work on international biological standards, biological reference preparations and biological reference reagents.

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  • 5-year impact
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  • Website
    Developments in Biologicals website
  • ISSN
    1424-6074
  • OCLC
    43626012
  • Material type
    Conference publication, Series, Internet resource
  • Document type
    Journal / Magazine / Newspaper, Internet Resource

Publisher details

Karger

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author can archive a post-print version
  • Conditions
    • On author or institutional server
    • Server must be non-commercial
    • Publisher's version/PDF cannot be used, unless Authors Choice fee is paid
    • Publisher copyright and source must be acknowledged
    • Must link to publisher version
    • Articles in some journals can be made Open Access on payment of additional charge
  • Classification
    ​ green

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: In late 2011 a novel virus of the Simbu serogroup, family Bunyaviridae, genus Orthobunyavirus, was discovered at the German-Dutch border and named "Schmallenberg virus" (SBV). Since then, the virus has spread rapidly to other European countries, and the involvement of biting midges has been demonstrated. Affected adult ruminants show none or only mild clinical signs including fever, reduced milk production or diarrhoea. However, in keeping with related viruses, an infection of SBV-naive cows and ewes during a critical period of pregnancy can lead to severe foetal malformations summarized as "arthrogryposis- hydranencephaly syndrome." Diagnostic assays like real-time RT-PCR and antibody ELISA are now available; and substantial knowledge of this virus has been gathered quickly. However, further research and exchange of information are essential. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:175-182.
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    ABSTRACT: Vaccination continues to be the most effective way to control Rift Valley fever (RVF), a zoonotic insect-borne viral disease of livestock. The irregular, cyclical and persistent nature of RVF in its occurrence in enzootic situations suggests that the vaccination strategy to be considered for these regions should be different from what is envisaged for free from risk regions. Currently available RVF vaccines have been extensively used for the control of the disease. However, these vaccines have shortcomings that have encouraged many research groups to develop new vaccine candidates that would address a large number of the current challenges, and be suitable for use both in disease-free regions and in different contingency and emergency preparedness strategies. The characteristics of different RVF vaccines and vaccination strategies are discussed in this report. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:61-72.
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    ABSTRACT: The development of countermeasures to support an effective response to Transboundary Animal Diseases (TAD) poses a challenge on a global scale and necessitates the coordinated involvement of scientists from government, industry and academia, as well as regulatory entities. The Agricultural Defense Branch under the Chemical and Biological Defense Division (CBD) of the Department of Homeland Security (DHS), Science and Technology Directorate (S&T) supports this important mission within the United States. This article provides an overview of the Agricultural Defense Branch's vaccine and diagnostic TAD project. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:3-14.
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    ABSTRACT: Since 1959, 32 epizootics of high pathogenicity avian influenza (HPAI) have occurred in birds. Rapid detection and accurate identification of HPAI has been critical to controlling such epizootics in poultry. Specific paradigms for the detection and diagnosis of avian influenza virus (AIV) in poultry vary somewhat among different countries and industry compartments depending on specific needs and resources. Importantly, since HPAI and low pathogenicity (LP) AI of the H5 and H7 subtypes are reportable to the World Organization for Animal Health (OIE), diagnostic procedures are implemented for regulatory purposes and are harmonized to some degree. Most current tests are adequate and have been in use for some time, therefore they have been well validated and presently there is no reported new technology that will completely replace the current tests. However, some modifications, updates or additional tests could be beneficial. The element of AIV diagnostics that is most in need of improvement is in determining the hemagglutinin and neuraminidase subtype specificity of antibody to AIV. Most HPAI epizootics have been eradicated using traditional stamping-out programs, but beginning in 1995, five epizootics have added vaccination as an additional, interim control tool. From 2002-2010, >113 billion doses of AI vaccine have been used in poultry; 95.5% as oil-emulsified, inactivated whole AIV vaccines and 4.5% as live vectored vaccines. The majority of vaccine has been used in the four H5N1 HPAI enzootic countries (China [91%], Egypt [4.7%], Indonesia [2.3%], and Vietnam [1.4%]) where vaccination programs are directed to all poultry. The 10 other countries/regions have used less than 1% of the vaccine, administered in a focused, risk- based approach. Some vaccine "failures" have resulted from antigenic drift of field viruses away from the vaccine viruses, but most have resulted from failures in the vaccination process; i.e. failure to adequately administer the vaccine to at risk poultry resulting in lack of population immunity. China, as the major AIV vaccine user, will drive innovation and commercialization of new vaccine technologies, but because of the low-cost to manufacture the current high quality inactivated whole AIV vaccines, such vaccines will continue to dominate the market for the next 10 years. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:79-94.
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    ABSTRACT: Classical swine fever is a serious and economically important transboundary disease threatening pig production globally. The infection may occur in backyard pigs, feral pig populations and domestic pigs. Whereas there are proven control strategies for the latter pig population, control in backyard pigs with poor biosecurity settings or in wild boar populations of high density still poses a problem in some parts of the world. Laboratory diagnostic methods, efficacious vaccines and contingency plans are in place in most industrialised countries. So far modified live vaccines (MLV) are still the first choice for rapid and reliable immune protection. Since antibodies elicited by conventional MLV cannot be distinguished from antibodies after natural infection, considerable efforts are put into the development of a live marker vaccine accompanied by a serological test. Nevertheless, some remaining gaps with respect to the diagnosis of and vaccination against classical swine fever have been identified. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:167-174.
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    ABSTRACT: Ebola viruses (EBOV; genus Ebolavirus, family Filoviridae) cause often fatal, hemorrhagic fever in several species of simian primates including human. While fruit bats are considered a natural reservoir, the involvement of other species in the EBOV transmission cycle is unclear, especially for domesticated animals. Dogs and pigs are so far the only domestic animals identified as species that can be infected with EBOV. In 2009 Reston-EBOV was the first EBOV reported to infect swine with indicated transmission to humans; and a survey in Gabon found over 30% seroprevalence for EBOV in dogs during the Ebola outbreak in 2001-2002. While infections in dogs appear to be asymptomatic, pigs experimentally infected with EBOV can develop clinical disease, depending on the virus species and possibly the age of the infected animals. In the experimental settings, pigs can transmit Zaire-Ebola virus to naive pigs and macaques; however, their role during Ebola outbreaks in Africa needs to be clarified. Attempts at virus and antibody detection require as a prerequisite validation of viral RNA and antibody detection methods especially for pigs, as well as the development of a sampling strategy. Significant issues about disease development remain to be resolved for EBOV. Evaluation of current human vaccine candidates or development of veterinary vaccines de novo for EBOV might need to be considered, especially if pigs or dogs are implicated in the transmission of an African species of EBOV to humans. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:211-218.
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    ABSTRACT: Heartwater, caused by the Rickettsiales Ehrlichia ruminantium (ER), is a tropical tick-borne disease of wild and domestic ruminants, transmitted by Amblyomma ticks. It causes significant economic losses due to high mortality and the high cost of antibiotic treatment of affected animals, limiting herd productivity. It is present in sub-Saharan Africa, islands in the Indian Ocean and two Caribbean islands (Guadeloupe and Antigua) from where it threatens the American mainland due to risk of the spread of infected A. variegatum by migratory birds or by uncontrolled movement of animals. If an accidental introduction of a tick-free ER carrier animal occurs, autochthonous A. maculatum has proven to be a good experimental vector for heartwater. Modeling A. variegatum population dynamics has been developed, but further work is needed to predict favourable habitats and allow targeted surveillance. We overview here the advances in diagnostics, vaccines and epidemiology of heartwater and analyze the research gaps and needs to mitigate potential ER introduction and spread on the American mainland. Effective serologic ELISA tests allow prevalence studies, and several PCR-based diagnostic tests are currently available to detect ER in sick animals. However, the development of rapid assays, including multi-pathogen tests, would enhance the efficacy and cost-effectiveness of heartwater diagnosis. Several experimental vaccines (inactivated, attenuated and recombinant) are under development. Attenuated and inactivated vaccines are effective against homologous strains but their efficacy in the field is decreased due to broad antigenic diversity of ER. New molecular typing assays are now being used to study the genetic structure of ER populations worldwide, but the linking of genotyping to cross-protection is still not straightforward. Currently an inactivated vaccine would be the most appropriate vaccine for the American mainland due to its safety, the availability of a fully controlled bioprocess allowing ER mass production andthe possibility to design "regional cocktail vaccines". This would require the selection andisolation of Caribbean ER strains supported by data of molecular epidemiology studies in thisregion. Development of an universal recombinant vaccine requires increased knowledge of ERbiology, including virulence mechanisms. Comparison of virulent and attenuated strains using"omic approaches" is on-going and will be crucial to understand these mechanisms and todevelop improved vaccines. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:191-200.
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    ABSTRACT: The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Veterinary Services (VS) is charged with monitoring, controlling, and responding to select reportable diseases and all foreign animal diseases. Emergency Management and Diagnostics (EM&D) oversees Foreign Animal Disease (FAD) preparedness and response. In order to effectively prepare for and respond to FADs, such as highly pathogenic avian influenza and foot-and-mouth disease, VS develops plans, strategies, and policies to effectively combat an intrusion. USDA APHIS VS has made significant gains in preparedness and response planning. However, much remains to be done especially in surveillance, diagnostic tools, and vaccines. There are significant needs for novel medical technologies to improve diagnostic capabilities and offer additional approaches for FAD response. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:15-22.
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    ABSTRACT: The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:53-58.
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    ABSTRACT: The need for better foot-and-mouth disease (FMD) vaccines is not new, a report from the Research Commission on FMD, authored by F. Loeffler and P. Frosch in 1897, highlighted the need for developing a vaccine against FMD and qualified this as a devastating disease causing "severe economic damage to the country's agriculture" [1]. Inactivated antigen vaccines have been available since the early 1900s and have been instrumental in eradicating FMD from parts of the world and repressing clinical disease in others. However, these vaccines require using live virulent FMDV for manufacturing, fail to prevent infection resulting in the establishment of carrier animals, require multiple vaccination schedules (every six months) and have limited coverage to the specific serotype and in many cases subtype of FMDV. Therefore, FMD vaccinology continues to be a very active research field. Research-based novel vaccine approaches over the last decade have resulted in at least one novel molecular vaccine being licensed for emergency use in the US and multiple other vaccine approaches being actively pursued as alternatives to current vaccines. Here we will review and update the main research efforts on FMD vaccines, including subunit and peptide vaccines, DNA vaccines, empty capsid vaccines (directly delivered or vector delivered), novel inactivated antigen production platforms and live attenuated vaccines. Each of these approaches will be discussed in terms of their safety and efficacy characteristics, product transition feasibility as well as their applicability to global control and eradication efforts. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:107-116.
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    ABSTRACT: Foot-and-mouth disease virus (FMDV) exists as multiple serotypes and strains that infect a range of cloven-hoofed animals with variable severity. Clinical diagnosis reinforced by diagnostic tests support timely intervention, whilst virus characterisation helps trace routes of spread and select appropriate vaccine strains. To speed up and simplify diagnosis, penside tests have recently been developed. Serology is used to identify undisclosed infection and substantiate freedom from infection and specific tests are needed to detect infected animals in vaccinated populations. Serology is also used to estimate post-vaccinal population immunity. Contingency plans are required to enable countries to scale up diagnosis at short notice. Improvements are needed in preclinical and penside diagnosis and in our ability to model vaccine effectiveness. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:117-123.
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    ABSTRACT: The National Animal Health Program at the Agricultural Research Service (ARS), United States Department of Agriculture (USDA), includes research programs dedicated to the defense of animal agriculture against the treat of biological agents with the potential of significant economic harm and/or public health consequences. This article provides a summary of the program and identifies its relevance to national initiatives to protect livestock and poultry as well as global food security. An introduction to setting research priorities and a selection of research accomplishments that define the scope of the biodefense research program is provided. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:23-37.
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    ABSTRACT: Ebola viruses are zoonotic pathogens with the potential of causing severe viral hemorrhagic fever in humans and nonhuman primates. Bats have been identified as a reservoir for Ebola viruses but it remains unclear if transmission to an end host involves intermediate hosts. Recently, one of the Ebola species has been found in Philippine pigs raising concerns regarding animal health and food safety. Diagnostics have so far focused on human application, but enhanced pig surveillance and diagnostics, particularly in Asia, for Ebola virus infections seem to be needed to establish reasonable guidelines for public and animal health and food safety. Livestock vaccination against Ebola seems currently not justified but proper preparedness may include experimental vaccine approaches. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:201-209.
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    ABSTRACT: Hendra virus and Nipah virus are viral zoonoses first recognized in the mid and late 1990's and are now categorized as the type species of the genus Henipavirus within the family Paramyxoviridae. Their broad species tropism together with their capacity to cause severe and often fatal disease in both humans and animals make Hendra and Nipah "overlap agents" and significant biosecurity threats. The development of effective vaccination strategies to prevent or treat henipavirus infection and disease has been an important area of research. Here, henipavirus active and passive vaccination strategies that have been examined in animal challenge models of Hendra and Nipah virus disease are summarized and discussed. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:125-138.
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    ABSTRACT: African swine fever virus is a large DNA virus which can cause an acute haemorrhagic fever in pigs resulting in high mortality. No vaccine is available, limiting options for control. The virus encodes up to 165 genes and virus particles are multi-layered and contain more than 50 proteins. Pigs immunised with natural low virulence isolates or attenuated viruses produced by passage in tissue culture and by targeted gene deletions can be protected against challenge with virulent viruses. CD8+ cells are required for protection induced by attenuated strain OURT88/3. Passive transfer of antibodies from immune to naïve pigs can also induce protection. Knowledge of the genome sequences of attenuated and virulent strains and targeted gene deletions from virulent strains have identified a number of virus genes involved in virulence and immune evasion. This information can be used to produce rationally attenuated vaccine strains. Virus antigens that are targets for neutralising antibodies have been identified and immunisation with these recombinant proteins has been shown to induce partial protection. However knowledge of antigens which encode the dominant protective epitopes recognised by CD8+ T cells is lacking. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:147-157.
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    ABSTRACT: Hendra virus (HeV) and Nipah virus (NiV) are the causative agents of emerging transboundary animal disease in pigs and horses. They also cause fatal disease in humans. NiV has a case fatality rate of 40 - 100%. In the initial NiV outbreak in Malaysia in 1999, about 1.1 million pigs had to be culled. The economic impact was estimated to be approximately US$450 million. Worldwide, HeV has caused more than 60 deaths in horses with 7 human cases and 4 deaths. Since the initial outbreak, HeV spillovers from Pteropus bats to horses and humans continue. This article presents a brief review on the currently available diagnostic methods for henipavirus infections, including advances achieved since the initial outbreak, and a gap analysis of areas needing improvement. Copyright © 2013 by the International Alliance for Biological Standardization (IABS), Carouge-Geneva (Switzerland).
    Developments in biologicals 01/2013; 135:139-145.

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