Life Sciences and Related Fields Trends Relevant to the Biological Weapons Convention (2011) / Chapter Skim
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2 The Pace of Developments in the Life Sciences
2 The Pace of Developments in the Life Sciences
Pages 25-58
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From page 25... ...
and in related, enabling technologies; • The diffusion of S&T research and its applications; and • The breadth of fields now engaged in the "life sciences." This chapter examines the first of these trends. 2.1 ADVANCES IN SCIENCE AND TECHNOLOGY 2.1.1 Developments Since 2006 As the message from United Nations Secretary General Ban Ki-moon to the BWC States Parties in 2010 (see Chapter 1)
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2.1.2 Genomics, Systems Biology, and Synthetic Biology Developments Since the draft sequence of the human genome was published in 2001 and the completed sequence announced in 2003 (HHS and DOE, 2003; International Human Genome Sequencing Consortium, 2004) , the sequencing of additional human genomes has proceeded rapidly.
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Pathways can also turn genes on and off, or spur a cell to move" (U.S. National Human Genome Research Institute, Fact Sheets: Biological Pathways, http://www.genome.gov/27530687, accessed August 29, 2011)
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Building on roots in both molecular biology and traditional engineering disciplines, synthetic biologists frequently conceive of cellular systems through the framework of elec tronic circuit design. As a result, biological modules may be viewed as functioning like switches, oscillators, logic-gates, and other electronic components; the framework is used as an aid in trying to design and conceptualize biological systems similar to the manner in which engineers design machines.
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Beyond typical circuit design issues, synthetic biologists must also account for cell death, crosstalk, mutations, intracellular, intercellular and extracellular condi tions, noise and other biological phenomena. A further difficult task is to correctly match suitable components in a designed system.
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The knowledge that results from these discoveries might eventually be used to explore new targets and mechanisms of action of biological agents, or new agents themselves, with implications for both protective and prophylactic purposes or for bioweapons. For example, understanding of immune pathways gained through systems biology approaches can be applied to the development of new vaccines (Oberg et al., 2011)
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From page 31... ...
This expanded base of knowledge is used to identify proteins, nucleic acids, or attenu ated pathogen strains for testing as vaccine candidates, to design vaccines and countermeasures that will stimulate aspects of the host immune response that are predicted to be effective in eliminating the pathogen, or to disrupt the mechanisms that a pathogen uses to bypass an effective host response. The increased DNA sequencing and characterization of individual genomic data and the correlation of different genetic variations with different responses to a pathogen or to a vaccine are also moving the field toward "personalized vaccinology" (Connell, 2010)
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The immunoprotective proteins encoded by the DNA are subsequently produced within host cells and expressed as anti gens on host cell surfaces, generating immune responses (Ledgerwood and Graham, 2009; Plotkin, 2009)
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However, advanced understanding of the immune system has potential dual use implications because it could be misap plied to create pathogens with increased virulence or to decrease the effectiveness of a human, animal, or plant immune response. A concern has been raised, for example, that as synthetic biology continues to advance it could be used to design novel pathogens for these functions.
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Developing and testing vaccines against these pathogens often requires the use of animal models because of ethical considerations that prevent experimental infection in humans and make conducting clinical trials problematic. In many cases, suitable animal models may not currently exist or the specific types and levels of immune responses that correlate with protection in humans are not well known (Matheny et al., 2007; NRC, 2006b)
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. Advances in delivery meth ods and formulations intersect with neuroscience research in, for example, developing improved therapeutics to cross the blood brain barrier (BBB)
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.16 International frameworks and conventions address appropriate uses of chemical and biological agents under treaties such as the BWC and CWC, under international human rights and humanitarian law, and in human subjects for medical research. The association of neuroscience with personality and with the integrity and dignity of a person seems to raise particular social and ethical issues that should be carefully considered.
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, and this may be an interesting area for further monitoring as research progresses and developments move closer to applications. 2.1.5 Production Systems Another area of active research in the life sciences is protein production, whether through the process of translation in transgenic organisms and cell culture systems, through the use of "cell-free" extracts, or by means of chemical synthesis.
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However, the creation of transgenic animals and the optimization of protein production in these systems generally require collaboration among teams of scientists and are both more expensive and more time consuming than is creation of a cell culture–based protein expression system (Slomski et al., 2010)
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From page 39... ...
These systems, which vary in their construction materials and in the design of components like stirrers and mixers, are used to culture bacterial, mammalian, and insect cell lines to express a desired protein, such as a monoclonal antibody therapeutic. Benchtop bioreactor systems generally hold several liters of cell culture (up to approximately 20L)
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Laboratory-scale cell culture bioreactors are already widely available and enable fairly rapid production of smaller quantities of proteins as well as the ability to scale up production by operating multiple bioreactors in parallel. The small size of laboratory-scale bioreactors also renders it
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thus have the potential to expand the definition of production facilities relevant to the BWC beyond traditional industrialscale operations. 2.1.6 Delivery Systems for Biological Molecules The prohibitions embodied by the BWC also apply to the means of delivery of biological agents.
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In particular, nanoparticulate drug delivery systems are under development that can be targeted to specific cells and organs, such as those of the reticuloendothelial system, by incorporation of surface recognition molecules from viruses or other infectious agents that normally hone to these cellular targets. The nanoparticulates may be lipid- or polymer-based and have been modified to carry antibiotics, siRNAs, peptides, nucleic acids, and other small molecules for immuno genic, therapeutic, or antimicrobial effects.
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From page 43... ...
agents or toxins for hostile purposes or in armed conflict." This provision relates to means of delivery specifically developed for the dissemination of biological and toxin agents for warfare purposes. But new biological weapons delivery methods may also come about as the result of legitimate research and development into means and methods of dissemination and administration of treatments for entirely legitimate purposes, for example to administer improved therapeutics and vaccines.
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As noted above, sensors incorporated into cell culture production systems are used to control and optimize culture conditions. However, biosensors are also used as diagnostic tools in medicine (Mascini and Tombelli, 2008; Rapp et al., 2010)
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Sensors are thus one from a range of identification and monitoring tools. The increased sequencing speed described previously is a recent development that could improve the overall efficacy of biosensors and detectors and has two main effects: first, high-speed sequencing can be incorporated into the analysis, whether as part of the device itself or as part of secondary analysis after collection of biological material; second, the pace of genetic sequencing allows researchers to create information databases that can be accessed by analysts to assist in identification of known bacteria and viruses.
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For example, a system that relies on collection of culturable material on a surface or in liquid will only be effective if the virus or bacterium survives collection and impact. A detector based on identification of genetic material will identify species that do not survive impact, but it could also issue unnecessary alerts by identifying material that belongs to dead bacteria or viruses posing no immediate risk to human or animal health.
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As discussed earlier in this chapter, this technology advances drug delivery options, allowing for improved uptake of therapeutics. However, such encapsula tion technology could also present a challenge for biosensors because it could hide the very surface characteristics being used to identify organ isms of concern.
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Understandings reached by the Sixth Review Conference of the BWC include "that all naturally or artificially created or altered microbial and other biological agents and toxins, as well as their components, regardless of their origin and method of production and whether they affect humans, animals or plants, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes, are unequivocally covered by Article I" (BWC, 2006)
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. The changing nature of biological production systems thus expands the understanding of potentially relevant production capabili ties beyond the traditional model of fixed, industrial-scale, cell culture fermentation tanks.
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Although an initial investment in such systems can be significant, they have the abil ity to greatly increase speed and capacity by analyzing multiple samples in parallel. DNA sequencing technology is one area that has experienced particularly rapid advances (de Villiers, 2010; Dhar, 2010; Pitt, 2010a,b; Taylor, 2010)
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A variety of new ("third" or "fourth" generation) DNA sequencing technologies are also on the horizon, some of which might produce longer DNA sequence lengths and higher accuracy than the current technology or might further increase speed and decrease costs (Niedringhaus et al., 2011; Shendure and Ji, 2008)
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National Human Genome Research Institute. Costs include labor, reagents and consumables, DNA preparation, amortization of instrument costs, and initial data processing, but not expenses such as technology and bioin formatics development and subsequent data analysis and interpretation.
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. These molecular dynamics simulations can be used to investigate the folding and interactions of proteins and nucleic acids, for example to examine predicted interactions between cellular receptors and drug candidates in efforts to advance biological understanding and improve therapeutics development.
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, making it the equivalent of the largest computer in the world. Similar types of volunteer distributed computing networks are available worldwide.
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. 2.2.3 Communication Technologies Changes in communication technologies, including access to the Internet, email, blogs, social media, mobile communication platforms, and open access publishing, are also enabling widespread dissemination of data and viewpoints and have the potential to change the ways in which scientists work (Meadway, 2010; Royal Society, 2011b)
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In addition, articles that will appear in future issues of a print journal are frequently available electronically in advance of print publication. The Internet also helps scientists identify specialists with whom to col laborate, although it has been reported that 90 percent of all collaborations are initiated in person (Royal Society, 2011b)
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2.2.4 Discussion and Implications of Enabling Technologies There has been particularly rapid progress in both access to and power of enabling technologies that underpin life sciences research, including computational and communication resources and high throughput labo ratory technologies. The computational power available to researchers continues to increase, through both specialized stand-alone computers and distributed computing networks.
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As discussed in Section 2.1, the committee did not identify any developments among those it surveyed that did so, a finding also reached by the scientific community at a workshop held prior to the Sixth BWC Review Conference in 2006 (Royal Society, 2006a,b)
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