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【bio-news】生物防务标准的建立
背景介绍
生物防务计划，是美国政府保护美国公民免受生物、化学和放射性攻击计划的重要组成部分，这一计划的实施，也将在发展稳定的生物防务产业方面迈出重要的一步。早在今年1月，布什总统在国情咨文中宣布了一项政府议案即生物防务计划，布什表示，根据这一计划，政府将在今后10年内拿出56亿美元建立反对生物恐怖主义的医药武器库。
这一计划受到了医药界的欢迎，支持者们认为这一提案一旦实施，从事生物防卫药物研究和生产的医药企业，其经济状况将得到根本改变。根据这一计划，政府不仅像过去那样对医药企业的研发进行投资，而且保证收购企业所有的产品，这样的话，医药企业再也不用担心那些治疗炭疽、波特淋菌中毒、埃博拉病毒引起的瘟疫等综合疗法没有稳定的市场了，政府将为战胜生物恐怖的药物建立有保障的市场。
Scott Jenkins and Joseph Perrone, The Need for Biodefense Standards,The scientist,2006,8
Scott Jenkins and Joseph Perrone, 需要生物防务标准，科学家，2006，8
The biodefense industry has reached a critical point in its evolution. To accelerate product development for biodefense-related diagnostics, therapeutics, and reagents, we urgently need biological consensus standards - which generally do not exist. These standards can have an impact on overall R&D productivity and quality as profound as any technological advance, a fact readily acknowledged by biodefense leaders.
Within biodefense-related R&D, standard biological materials and processes are critical in three general areas. First, standards help properly validate instruments and assays used in measuring, producing, or testing products for biodefense applications. For example, scientists need standard microorganisms to validate an instrument designed to identify threat agents from environmental samples in the field. Second, we need standard biodefense-related materials and protocols to train personnel and confirm the capabilities of a biodefense laboratory; standards are invaluable for evaluating an individual's or laboratory's performance at identifying or assaying particular bioagents. Third, standards help compare experimental results among different researchers and different laboratories, enabling groups across the hall or across the globe to weigh results meaningfully. This enables high-quality and efficient research and testing, and it also stimulates innovation.
Standards are most effective when developed by the cadre of people who have the most to gain by their use. A provision of the National Technology Transfer and Advancement Act (1996; P.L. 104-113) states: Wherever possible, groups should use voluntary consensus standards developed by a community of interested stakeholders, rather than federally mandated regulations.
To jumpstart development of these standards, the American Type Culture Collection (ATCC) convened the Expert Panel on the Development of Standards for Biodefense in Washington, DC, in early April. The meeting represented a launching point for a process that will culminate in the development of voluntary consensus standards for critical materials and protocols for biodefense-related research and product development. A group of approximately 60 experienced biodefense experts gathered from a range of government agencies, academic institutions, and private companies.
Instead of writing specific standards, participants first delineated the areas of need for biodefense materials and processes. In discussion over the course of the two-day meeting, a broad agreement was reached on a handful of areas of need for biodefense standards. Participants also generated even more questions and issues that still require resolution. The areas of need include:
>> Standard reference materials - Participants strongly agreed that a major unmet need exists for universally accepted reference standard biological materials, including microorganisms posing public health threats. Such reference materials would be used as benchmarks in the study and testing of bioagents. Discussion at the meeting, however, focused more on how to define a reference material than on which bioagents should have standards. To define a material as a reference standard, what characteristics of the organisms constitute required knowledge? Much consideration and decision-making remains before, for example, experts can establish a reference standard Bacillus anthracis Ames strain. Nonetheless, meeting participants acknowledged that the set of information should include genetic profile, phylogenic position, microbe source, purity, and chain of custody.
Standard measurement protocols - Once a set of requisite information is established, the next critical step is to define and agree to measurement protocols for each piece of information, the participants reasoned. For example, how should the purity of cultures and reagents be assessed, and what levels of impurity, if any, would be acceptable? How should one measure infectivity, virulence, or stability of an organism in various environments? Any group setting out to develop standard measurement protocols must consider what types of measurement devices and instruments on which to seek agreement, as well as what levels of specificity vs. sensitivity are acceptable. As a sample problem, what would be the criteria for successful decontamination of an area where a bioagent was detected? Panelists suggested that experts set standards on methods of bioagent characterization, and managing the information associated with the biological materials as well as evaluating countermeasures.
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作者:admin@医学,生命科学 2011-09-08 05:13
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