There are two major aspects that define the field of Synthetic biology:
1. The design of novel biological components and systems.
2. The re-design of existing biological systems.
1. Biological Engineering uses engineering disciplines to improve and focus utilization of biological systems. (4)
2. Similar to synthetic biology, biological engineering exploits new developments other biological fields however biological engineering applies these breakthroughs to understand living systems with the goal of solving natural problems with these systems. (4)
3. Systems biology is focuses on the study on natural systems, often with some long term medical significance
4. But the work is fundamentally an engineering application of biological science, rather than an attempt to do more science. (5)
Scientists have high hopes for the future of synthetic biology. Initially scientist believe that the way the research proceeds it will illuminate previously unknown aspects of the natural world. (5) The idea is that with the ability to generate organisms, de novo, allows us to better understand how natural mechanisms and systems work. Apart from biologists, other scientists such as chemists and physicists are interested in the possibility of probing molecules of interest in living cells and systems that are currently impossible to study. The promise of developing circuits based entirely off biological parts to control things in people's bodies and in other settings is another potential outcome of the development of synthetic biology. Additionally the design of processing techniques based on novel biological organisms and machines hold the potential to revolutionize industrial manufacturing, energy production and refinement, and food and pharmaceutical processing.
As with many newly developing fields and technologies there are risks associated with each possible benefit the new technology brings. In the context of synthetic biology these risks are of the type that could potentially make people sick or come in the form of a bio-weapon, and given the seriousness of these risks many people have been questioning the risk:benefit ratio that is possible from this field. The scientists that are involved in the research are actively participating in these debates. One of the immediate goals of these scientists are to reduce the possible backlash of any negative outcomes found from synthetic biology and to help to rectify and problems found.
There are three major negative outcomes the research in synthetic biology may result in (5):
In an effort to help eliminate the above three possibilities the following three measures are being taken (5):
David Baltimore, the president of the California Institute of Technology, said, “nature is a very tough critic”. He was implying that nature has done well for herself. It is likely that any organism that we synthetically create would not survive well in a natural environment due to the large amount of competition it would have to deal with from the many other organisms in this world which have all undergone a large amount of natural selection. (6)
A study commissioned by the Alfred P Sloan foundation was designed to evaluate the risks and effects synthetic biology could entail such as: the possible biosafety and biosecurity issue, environmental issue, in intellectual property rights conflicts, and possible theological questions. The report was published through The Hastings Center, which is a institution dedicated to research on bioethics (7). The authors included Michele Garfinkel a policy analyst at the J Craig Venter Institute, Drew Endy a synthetic biologist at Stanford University, Gerald Epstein a senior fellow for science and security at the Center for strategic and International Studies, and Robert Friedman the Deputy Director of the J Craig Venter Institute. Combining these people, with broad experiences and expertises made this report quite valuable to the public and other scientists.
They began with the issue of biosafety and biosecurity in which they first identified key technologies such as DNA synthesis and gene synthesis among the more important to focus on (7). These techniques allow scientist produce artificial pieces of DNA of any length and sequence. They found that the current technologies are not sufficient to pose a large threat to actually produce and distribute some harmful DNA sequence. However they did caution that within 5-10 years time, the technology would be sufficiently efficient to produce enough large pieces of DNA to be a concern. They suggested things such as screening the sequences companies produce for the potential to be harmful. In fact firms such as Codon Devices already implement procedures like this screening to ensure they are not producing malicious DNA sequences.
The environmental impact was assessed next and the basic conclusion was that it will likely be the case that all synthetically created foods or edible organisms will need to go through the same regulations all other genetically modified organisms already are subjected to. The EPA, FDA, and Department of Agriculture already regulate the introduction of modified food, drugs, etc, so they will likely handle these new organisms as well. In addition to the environmental impact of the introduction of novel organisms there is a business and ownership associated with these introductions. The acquisition of intellectual property (IP) and patents on these novel organisms will undoubtedly be large and companies will work to move quickly to scoop up as much IP as possible. This aspect of the debate and emerging field has the potential to halt the advancement of it if institutions and companies all hold patents and are unwilling to work with one another. A situation could develop where an anticommons is created where many patent owners block each other's actions or a patent thicket develops where a person interested in doing research need to receive licenses from multiple paten-owners (7).
The final issue the study addressed, and possible the most important to the general public debate, is that of the philosophical or theological one. The goals of many of the scientist in synthetic genomics is to create a minimal genome and to develop and design completely novel organisms. These efforts may in fact also act to change the definition of life at the same time. The scientists who have been asked about the moral and ethical issues about the construction of a minimal genome have not deemed it ethically improper. There are of course people who disagreed that this is a morally acceptable thing to be pursuing, however little additional research and effort had been put into determining exactly what should be done, likely because the scientist in favor of it have more power and say in the matter than the dissenters.