The emergence of synthetic biology holds the potential of a major breakthrough in the life sciences by transforming biology into a predictive science. The dual-use characteristics of similar breakthroughs during the twentieth century have led to the application of benignly intended research in e.g. virology, bacteriology and aerobiology in offensive biological weapons programmes. Against this background the article raises the question whether the precautionary governance of synthetic biology can aid in preventing this techno-science witnessing the same fate? In order to (...) address this question, this paper proceeds in four steps: it firstly introduces the emerging techno-science of synthetic biology and presents some of its potential beneficial applications. It secondly analyses contributions to the bioethical discourse on synthetic biology as well as precautionary reasoning and its application to life science research in general and synthetic biology more specifically. The paper then identifies manifestations of a moderate precautionary principle in the emerging synthetic biology dual-use governance discourse. Using a dual-use governance matrix as heuristic device to analyse some of the proposed measures, it concludes that the identified measures can best be described as “patchwork precaution” and that a more systematic approach to construct a web of dual-use precaution for synthetic biology is needed in order to guard more effectively against the field’s future misuse for harmful applications. (shrink)

The phrase ‘synthetic biology’ is used to describe a set of different scientific and technological disciplines, which share the objective to design and produce new life forms. This essay addresses the following questions: What conception of life stands behind this ambitious objective? In what relation does this conception of life stand to that of traditional biology and biotechnology? And, could such a conception of life raise ethical concerns? Three different observations that provide useful indications for the conception of life in (...) synthetic biology will be discussed in detail: 1. Synthetic biologists focus on different features of living organisms in order to design new life forms, 2. Synthetic biologists want to contribute to the understanding of life, and 3. Synthetic biologists want to modify life through a rational design, which implies the notions of utilising, minimising/optimising, varying and overcoming life. These observations indicate a tight connection between science and technology, a focus on selected aspects of life, a production-oriented approach to life, and a design-oriented understanding of life. It will be argued that through this conception of life synthetic biologists present life in a different light. This conception of life will be illustrated by the metaphor of a toolbox. According to the notion of life as a toolbox, the different features of living organisms are perceived as various rationally designed instruments that can be used for the production of the living organism itself or secondary products made by the organism. According to certain ethical positions this conception of life might raise ethical concerns related to the status of the organism, the motives of the scientists and the role of technology in our society. (shrink)

The emergent new science of synthetic biology is challenging entrenched distinctions between, amongst others, life and non-life, the natural and the artificial, the evolved and the designed, and even the material and the informational. Whenever such culturally sanctioned boundaries are breached, researchers are inevitably accused of playing God or treading in Frankenstein’s footsteps. Bioethicists, theologians and editors of scientific journals feel obliged to provide an authoritative answer to the ambiguous question of the ‘meaning’ of life, both as a scientific definition (...) and as an explication with wider existential connotations. This article analyses the arguments mooted in the emerging societal debates on synthetic biology and the way its practitioners respond to criticism, mostly by assuming a defiant posture or professing humility. It explores the relationship between the ‘playing God’ theme and the Frankenstein motif and examines the doctrinal status of the ‘playing God’ argument. One particularly interesting finding is that liberal theologians generally deny the religious character of the ‘playing God’ argument—a response which fits in with the curious fact that this argument is used mainly by secular organizations. Synthetic biology, it is therefore maintained, does not offend so much the God of the Bible as a deified Nature. While syntheses of artificial life forms cause some vague uneasiness that life may lose its special meaning, most concerns turn out to be narrowly anthropocentric. As long as synthetic biology creates only new microbial life and does not directly affect human life, it will in all likelihood be considered acceptable. (shrink)

This paper examines how scientific understanding is enhanced by virtual entities, focusing on the case of the synthetic cell. Comparing it to other virtual entities and environments in science, we argue that the synthetic cell has a virtual dimension, in that it is functionally similar to living cells, though it does not mimic any particular naturally evolved cell (nor is it constructed to do so). In being cell-like at most, the synthetic cell is akin to many other virtual objects as (...) it is selective and only partially implemented. However, there is one important difference: it is constructed by using the same materials and, to some extent, the same kind of processes as its natural counterparts. In contrast to virtual reality, especially to that of digital entities and environments, the details of its implementation is what matters for the scientific understanding generated by the synthetic cell. We conclude by arguing for the close connection between the virtual and the artifactual. (shrink)

According to Bedau and Triant decision-makers will be substantially ignorant about the consequences of their candidate choices when making decisions about synthetic biology. Bedau and Triant charac...

Recently, several critics of the multiple realizability thesis have argued that philosophers have tended to accept the thesis on too weak grounds. On the one hand, the analytic challenge has problematized how philosophers have treated the multiple realization relation itself, claiming that assessment of the sameness of function and the relevant difference of realizers has been uncritical. On the other hand, it is argued that the purported evidence of the thesis is often left empirically unverified. This paper provides a novel (...) strategy to answer these worries by introducing a role for multiple realizability in the context of biological engineering. In the field of synthetic biology, bioengineers redesign the evolutionary realizations of biological functions, even constructing artificial chemical surrogates in the laboratory. I show how in the rational design approach to biological engineering, multiple realizability can function as a design heuristic in which the sameness of function and difference of realizers can be controlled. Although practically motivated, this engineering approach has also a theoretical, exploratory component that can be used to study the empirical limitations of multiple realizability. Successful realization of the engineering designs would amount to a concrete demonstration of multiple realizability, taking evidence for MRT beyond what is readily found in nature. (shrink)

Vitalism was long viewed as the most grotesque view in biological theory: appeals to a mysterious life-force, Romantic insistence on the autonomy of life, or worse, a metaphysics of an entirely living universe. In the early twentieth century, attempts were made to present a revised, lighter version that was not weighted down by revisionary metaphysics: “organicism”. And mainstream philosophers of science criticized Driesch and Bergson’s “neovitalism” as a too-strong ontological commitment to the existence of certain entities or “forces”, over and (...) above the system of causal relations studied by mechanistic science, rejecting the weaker form, organicism, as well. But there has been some significant scholarly “push-back” against this orthodox attitude, notably pointing to the 18th-century Montpellier vitalists to show that there are different historical forms of vitalism, including how they relate to mainstream scientific practice. Additionally, some trends in recent biology that run counter to genetic reductionism and the informational model of the gene present themselves as organicist. Here, we examine some cases of vitalism in the twentieth century and today, not just as a historical form but as a significant metaphysical and scientific model. We argue for vitalism’s conceptual originality without either reducing it to mainstream models of science or presenting it as an alternate model of science, by focusing on historical forms of vitalism, logical empiricist critiques thereof and the impact of synthetic biology on current theorizing of vitalism. (shrink)

Synthetic biology is described as a new field of biotechnology that models itself on engineering sciences. However, this view of synthetic biology as an engineering field has received criticism, and both biologists and philosophers have argued for a more nuanced and heterogeneous understanding of the field. This paper elaborates the heterogeneity of synthetic biology by clarifying the role of design and the variability of design methodologies in synthetic biology. I focus on two prominent design methodologies: rational design and directed evolution. (...) Rational design resembles the design methodology of traditional engineering sciences. However, it is often replaced and complemented by the more biologically-inspired method of directed evolution, which models itself on natural evolution. These two approaches take philosophically different stances to the design of biological systems. Rational design aims to make biological systems more machine-like, whereas directed evolution utilizes variation and emergent features of living systems. I provide an analysis of the methodological basis of these design approaches, and highlight important methodological differences between them. By analyzing the respective benefits and limitations of these approaches, I argue against the engineering-dominated conception of synthetic biology and its “methodological monism”, where the rational design approach is taken as the default design methodology. Alternative design methodologies, like directed evolution, should be considered as complementary, not competitive, to rational design. (shrink)

A majority opinion seems to have emerged in scholarly analysis of the assortment of technologies that have been given the label “synthetic biology.” According to this view, society should allow the technology to proceed and even provide it some financial support, while monitor­ing its progress and attempting to ensure that the development leads to good outcomes. The near‐consensus is captured by the U.S. Presidential Commission for the Study of Bioethical Issues in its report New Directions: The Ethics of Synthetic Biology (...) and Emerging Technologies, which arguably marked the end of a preliminary round of analysis about the ethical and policy questions raised by synthetic bi­ology. Like a number of other, earlier documents issued by various groups around the world, the re­port called attention to questions about how the technology will be used; whether it might be mis­used; what sorts of accidents might happen along the way; the economic, environmental, and social impacts of the eventual applications; whether the very idea of “synthetic biology” should be trou­bling; and how the debate over all of these ques­tions will be conducted. Also like most similar documents, however, while it called for careful monitoring and oversight of technology, it did not recommend any significant new constraints on its development and use. The commission's stance was that it would be “imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply ‘let science rip,’ regardless of the likely risks.”In this report, we will take stock of the current consensus, comment on some of the major points of disagreement, and identify the next steps for the debate. In part I, we offer a brief overview of the research and applications commonly grouped together under the heading of synthetic biology, partly in order to set the stage for the rest of the discussion and partly because we want to highlight some conceptual problems that attend the very la­bel given this field. In parts II, III, and IV, we take up, respectively, three broad classes of concerns that arise in the context of synthetic biology: con­cerns about the intrinsic or inherent value of do­ing synthetic biology, concerns about the concrete harms and benefits of doing synthetic biology, and concerns about justice. Addressing these concerns requires a method for bringing the public's values to bear on policy‐making concerning emerging biotechnologies; in part V, we discuss the chal­lenges in developing such a method. (shrink)

“Proof of concept” is a phrase frequently used in descriptions of research sought in program announcements, in experimental studies, and in the marketing of new technologies. It is often coupled with either a short definition or none at all, its meaning assumed to be fully understood. This is problematic. As a phrase with potential implications for research and technology, its assumed meaning requires some analysis to avoid it becoming a descriptive category that refers to all things scientifically exciting. I provide (...) a short analysis of proof of concept research and offer an example of it within synthetic biology. I suggest that not only are there activities that circumscribe new epistemological categories but there are also associated normative ethical categories or principles linked to the research. I examine these and provide an outline for an alternative ethical account to describe these activities that I refer to as “extended agency ethics”. This view is used to explain how the type of research described as proof of concept also provides an attendant proof of principle that is the result of decision-making that extends across practitioners, their tools, techniques, and the problem solving activities of other research groups. (shrink)

Synthetic biologists try to engineer useful biological systems that do not exist in nature. One of their goals is to design an orthogonal chromosome different from DNA and RNA, termed XNA for xeno nucleic acids. XNA exhibits a variety of structural chemical changes relative to its natural counterparts. These changes make this novel information‐storing biopolymer “invisible” to natural biological systems. The lack of cognition to the natural world, however, is seen as an opportunity to implement a genetic firewall that impedes (...) exchange of genetic information with the natural world, which means it could be the ultimate biosafety tool. Here I discuss, why it is necessary to go ahead designing xenobiological systems like XNA and its XNA binding proteins; what the biosafety specifications should look like for this genetic enclave; which steps should be carried out to boot up the first XNA life form; and what it means for the society at large. (shrink)

Synthetic biology is an umbrella term that covers a range of aims, approaches, and techniques. They are all brought together by common practices of analogizing, synthesizing, mechanicizing, and kludging. With a focus on kludging as the connection point between biology, engineering, and evolution, I show how synthetic biology’s successes depend on custom-built kludges and a creative, “make-it-work” attitude to the construction of biological systems. Such practices do not fit neatly, however, into synthetic biology’s celebration of rational design. Nor do they (...) straightforwardly embody Richard Feynman’s “last blackboard” statement that without creating something it cannot be understood. Reflecting further on the relationship between synthetic construction and knowledge making gives philosophy of science new avenues of insight into scientific practice. (shrink)

A widespread and influential characterization of synthetic biology emphasizes that synthetic biology is the application of engineering principles to living systems. Furthermore, there is a strong tendency to express the engineering approach to organisms in terms of what seems to be an ontological claim: organisms are machines. In the paper I investigate the ontological and heuristic significance of the machine analogy in synthetic biology. I argue that the use of the machine analogy and the aim of producing rationally designed organisms (...) does not necessarily imply a commitment to mechanical biology. The ideal of applying engineering principles to biology is best understood as expressing recognition of the machine-unlikeness of natural organisms and the limits of human cognition. The paper suggests an interpretation of the identification of organisms with machines in synthetic biology according to which it expresses a strategy for representing, understanding, and constructing living systems that are more machine-like than natural organisms. (shrink)

Synthetic genomics is a new field of research in which small DNA pieces are assembled in a series of steps into whole genomes. The highly reduced genomes of host‐associated bacteria are now being used as models for de novo synthesis of small genomes in the laboratory. Bacteria with the smallest genomes identified in nature provide nutrients to their hosts, such as amino acids, co‐factors and vitamins. Comparative genomics of these bacteria enables predictions to be made about the gene sets required (...) for core cellular functions and the associated metabolic network for the biosynthesis of host‐selected compounds. Synthetic biology may ultimately enable researchers to make customized cell‐specific organelles for the production and delivery of drugs to humans and domestic animals. Synthetic genomics may also become the method of choice for functional analyses of genes and genomes from bacteria that cannot be cultivated in the laboratory. (shrink)

In this short contribution we explore the historical roots of recent synthetic approaches in biology and try to assess their real potential, as well as identify future hurdles or the reasons behind some of the main difficulties they currently face. We suggest that part of these difficulties might not be just the result of our present lack of adequate technical skills or understanding, but could spring directly from the nature of the biological phenomenon itself. In particular, if life is conceived (...) as autonomy in open-ended evolution, which would help to explain the highly complex and dynamic organization of the simplest known organisms (i.e., genetically-instructed cellular metabolisms), external synthetic implementations of such systems, or interventions on them, are bound to interfere with some of their characteristic transformation processes, both at the ontogenetic and phylogenetic scales. In any case, this will prove very revealing and productive, technologically and scientifically speaking, since the knowledge gathered from those implementations/interventions will be extremely valuable in establishing our capacities and limitations to fully comprehend, utilize, and expand the living domain as we know it today. (shrink)

In this paper, I discuss the aetiological account of biological interests, developed by Varner, in the context of artefactual organisms envisioned by current research in synthetic biology. In “Sections 2–5”, I present Varner's theory and criticise it for being incapable of ascribing non-derivative interests to artefactual organisms due to their lack of a history of natural selection. In “Sections 6–7”, I develop a new alternative to Varner's account, building on the organisational theory of biological teleology and function. I argue that (...) the organisational account of biological interest is superior to Varner's aetiological account because it can accommodate both artefactual and naturally evolved organisms, provides a non-arbitrary and practical way of determining biological interests, supports the claim that organisms have interests in a sense in which artefacts do not, and avoids the possibility of there being a conflict between what an organismic part is supposed to do and what is in the interest of the organism. (shrink)

Vitalism was long viewed as the most grotesque view in biological theory: appeals to a mysterious life-force, Romantic insistence on the autonomy of life, or worse, a metaphysics of an entirely living universe. In the early twentieth century, attempts were made to present a revised, lighter version that was not weighted down by revisionary metaphysics: “organicism”. And mainstream philosophers of science criticized Driesch and Bergson’s “neovitalism” as a too-strong ontological commitment to the existence of certain entities or “forces”, over and (...) above the system of causal relations studied by mechanistic science, rejecting the weaker form, organicism, as well. But there has been some significant scholarly “push-back” against this orthodox attitude, notably pointing to the 18th-century Montpellier vitalists to show that there are different historical forms of vitalism, including how they relate to mainstream scientific practice (Wolfe and Normandin, eds. 2013). Additionally, some trends in recent biology that run counter to genetic reductionism and the informational model of the gene present themselves as organicist (Gilbert and Sarkar 2000, Moreno and Mossio 2015). Here, we examine some cases of vitalism in the twentieth century and today, not just as a historical form but as a significant metaphysical and scientific model. We argue for vitalism’s conceptual originality without either reducing it to mainstream models of science or presenting it as an alternate model of science, by focusing on historical forms of vitalism, logical empiricist critiques thereof and the impact of synthetic biology on current (re-)theorizing of vitalism. (shrink)

Theorists analyzing the concept of disease on the basis of the notion of dysfunction consider disease to be dysfunction requiring. More specifically, dysfunction-requiring theories of disease claim that for an individual to be diseased certain biological facts about it must be the case. Disease is not wholly a matter of evaluative attitudes. In this paper, I consider the dysfunction-requiring component of Wakefield’s hybrid account of disease in light of the artifactual organisms envisioned by current research in synthetic biology. In particular, (...) I argue that the possibility of artifactual organisms and the case of oncomice and other bred or genetically modified strains of organism constitute a significant objection to Wakefield’s etiological account of the dysfunction requirement. I then develop a new alternative understanding of the dysfunction requirement that builds on the organizational theory of function. I conclude that my suggestion is superior to Wakefield’s theory because it (a) can accommodate both artifactual and naturally evolved organisms, (b) avoids the possibility of there being a conflict between what an organismic part is supposed to do and the health of the organism, and (c) provides a nonarbitrary and practical way of determining whether dysfunction occurs. (shrink)

The Precautionary Principle is a highly influential feature of an extensive body of environmental law, and is also highly controversial and continues to generate scholarly debates along several dim...

New health technologies are rapidly emerging from various areas of bioscience research, such as gene editing, regenerative medicine and synthetic biology. These technologies raise promising medical possibilities but also a range of ethical considerations. Apart from the issues involved in considering whether novel health technologies can or should become part of mainstream medical treatment once established, the process of research translation to develop such therapies itself entails particular ethical concerns. In this paper I use synthetic biology as an example of (...) a new and largely unexplored area of health technology to consider the ways in which novel health technologies are likely to emerge and the ethical challenges these will present. I argue that such developments require us to rethink conventional attitudes towards clinical research, the roles of doctors/researchers and patients/participants with respect to research, and the relationship between science and society; and that a broader framework is required to address the plurality of stakeholder roles and interests involved in the development of treatments based on novel technologies. (shrink)

Social scientific and humanistic research on synthetic biology has focused quite narrowly on questions of epistemology and ELSI. I suggest that to understand this discipline in its full scope, researchers must turn to the objects of the field—synthetic biological artifacts—and study them as the objects in the making of a science yet to be made. I consider one fundamentally important question: how should we understand the material products of synthetic biology? Practitioners in the field, employing a consistent technological optic in (...) the study and construction of biological systems, routinely employ the mantra ‘biology is technology’. I explore this categorization. By employing an established definition of technological artifects drawn from the philosophy of technology, I explore the appropriateness of attributing to synthetic biological artifacts the four criteria of materiality, intentional design, functionality, and normativity. I then explore a variety of accounts of natural kinds. I demonstrate that synthetic biological artifacts fit each kind imperfectly, and display a concomitant ontological ‘messiness’. I argue that this classificatory ambivalence is a product of the field’s own nascence, and posit that further work on kinds might help synthetic biology evaluate its existing commitments and practices. (shrink)

Social studies of knowledge have contributed many insights into the making and the character of scientific and technological knowledge. However, studies of knowledge use are scarce. This article engages with under-examined topics concerning epistemic utility. I posit and demonstrate that scientific and technological knowledge claims are functional. I argue that knowledge and its functions are mutually-enabling and mutually-sustaining constructs. To substantiate my claims, I present useful conceptualisations of ‘function’ and ‘functionality’ and employ them in an empirical case study. I examine (...) knowledge use in synthetic biology, a young form of biological engineering. I demonstrate that knowledge in the field is brought into existence with function in mind, kept in existence through functional use, qualified and situated by its functionality and evaluated by its functional operation. The case study reveals the effectiveness of my conceptualisations and offers lessons about knowledge as both an end-result of epistemic work and a mechanism for practice. My theoretical and empirical contributions expand understanding of scientific and technological knowledge and shed light on an area of study awaiting investigation. I conclude with open-ended reflections on work yet to be done. (shrink)

Synthetic biology is a research field that has grown rapidly and attracted considerable attention. Most prominently, it has been labelled the ‘engineering of biology’. While other attempts to label the field have been also pursued, the program of engineering can be considered the core of the field’s disciplinary program, of its identity. This article addresses the success of the ‘engineering program’ in synthetic biology and argues that its success can partly be explained by distinct practices of persuasion that aim at (...) persuading scientific, but also non-scientific audiences. The article explores two different modes of persuasion:, building tools as heuristic models and posing visionary claims. Objects such as the toggle switch or the synthetic oscillator in synthetic biology can more adequately be described as heuristic models of engineering instead of simply as prototypes of ‘tools’. Posing visionary claims can be also understood as a persuasion practice, since the claims are used to construct the societal relevance of the field. Drawing upon Michel Callon’s ‘sociology of translation’, I argue that both practices of persuasion aim at ‘enrolling’ entities into the disciplinary identity. The article is based on the textual analysis of rhetorical practices in three synthetic biology review articles which are considered seminal for the history of the field. (shrink)

A team of US researchers recently reported the design, assembly and in vivo functionality of a synthetic chromosome III (SynIII) for the yeast Saccharomyces cerevisiae. The synthetic chromosome was assembled bottom‐up from DNA oligomers by teams of students working over several years with researchers as the first part of an international synthetic yeast genome project. Embedded into the sequence of the synthetic chromosome are multiple design changes that include a novel in‐built recombination scheme that can be induced to catalyse intra‐chromosomal (...) rearrangements in a variety of different conditions. This system, along with the other synthetic sequence changes, is intended to aid researchers develop a deeper understanding of how genomes function and find new ways to exploit yeast in future biotechnologies. The landmark of the first synthesised designer eukaryote chromosome, and the power of its massively parallel recombination system, provide new perspectives on the future of synthetic biology and genome research. (shrink)