The Assurance Timeline: Building Assurance Cases for Synthetic Biology
The Assurance Timeline: Building Assurance Cases for Synthetic Biology
复制标题
保证时间表：构建合成生物学的保证案例
DOI：
10.1007/978-3-319-45480-1_7
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发表时间：
2016
影响因子：
3.4
通讯作者：
M. Pierobon
中科院分区：
文献类型：
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作者：
Myra B. Cohen;Justin W. Firestone;M. Pierobon
最近在修饰和控制DNA方面的研究进展创造了一个蓬勃发展的生物工程领域，称为合成生物学。在合成生物学中，工程师操纵和修改活的有机体以改变(并产生全新的)功能，这导致了新的燃料来源或减轻污染的能力。合成生物学的研究也有望带来智能药物输送的方法。在合成生物学中，设计首先是使用生物编程语言构建的，然后在实验室实现。这些合成有机体可以被认为是生命程序，当人类在自然环境中生存时，它们将感知、反应并与人类互动。我们认为，我们应该将这些设备视为安全关键设备，既可以进行监管，也可以进行认证。由于合成工程生物遵循涉及突变的繁殖和复制的规则周期，它们最终将随着时间的推移适应和进化新的行为。在这篇文章中，我们建议使用一个合成工程生物体的保证案例，并提出一个正交维，一个保证时间表，可以用来推理这些系统的动态、不断演变的方面。我们给出了一个基于实际应用的案例研究来说明我们的想法。
Recent research advances in modifying and controlling DNA have created a booming field of biological engineering called synthetic biology. In synthetic biology engineers manipulate and modify living organisms to change (and produce entirely novel) functionality, which has led to new fuel sources or the ability to mitigate pollution. Synthetic biology research is also expected to lead to methods of intelligent drug delivery. In synthetic biology, designs are first built using biological programming languages and then implemented in a laboratory. These synthetic organisms can be considered living programs that will sense, respond and interact with humans while they persist in the natural environment. We argue that we should view these as safety critical devices which can be both regulated and certified. Since the synthetically engineered organisms follow a regular cycle of reproduction and replication that involves mutations, they will eventually adapt and evolve new behavior over time. In this paper we propose the use of an assurance case for synthetically engineered organisms, and present an orthogonal dimension, an assurance timeline, that can be used to reason about the dynamic, evolving aspects of these systems. We present a case study based on a real application to illustrate our ideas.