Synthetic Biology Needs Safety and Stability before Real World Application

Synthetic biology needs robust safety mechanisms before real world application

Ethics and technology hold the key to the success of synthetic biology

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Amsterdam

September 16, 2015

Targeted cancer treatments, toxicity sensors and living factories: synthetic biology has the potential to revolutionize science and medicine. But before the technology is ready for real-world applications, more attention needs to be paid to its safety and stability, say experts in a review article published in Current Opinion in Chemical Biology.

[caption id="attachment_270" align="aligncenter" width="560"] Synthetic Biology Needs Safety and Stability before Real World Application[/caption]

Synthetic biology involves engineering microbes like bacteria to program them to behave in certain ways. For example, bacteria can be engineered to glow when they detect certain molecules, and can be turned into tiny factories to produce chemicals.

Synthetic biology has now reached a stage where it's ready to move out of the lab and into the real world, to be used in patients and in the field. According to Professor Pamela Silver, one of the authors of the article from Harvard Medical School in the US, this move means researchers should increase focus on the safety of engineered microbes in biological systems like the human body.

"Historically, molecular biologists engineered microbes as industrial organisms to produce different molecules," said Professor Silver. "The more we discovered about microbes, the easier it was to program them. We've now reached a very exciting phase in synthetic biology where we're ready to apply what we've developed in the real world, and this is where safety is vital."

Microbes have an impact on health; the way they interact with animals is being ever more revealed by microbiome research - studies on all the microbes that live in the body - and this is making them easier and faster to engineer. Scientists are now able to synthesize whole genomes, making it technically possible to build a microbe from scratch.

"Ultimately, this is the future - this will be the way we program microbes and other cell types," said Dr. Silver. "Microbes have small genomes, so they're not too complex to build from scratch. That gives us huge opportunities to design them to do specific jobs, and we can also program in safety mechanisms."

One of the big safety issues associated with engineering microbial genomes is the transfer of their genes to wild microbes. Microbes are able to transfer segments of their DNA during reproduction, which leads to genetic evolution. One key challenge associated with synthetic biology is preventing this transfer between the engineered genome and wild microbial genomes.

There are already several levels of safety infrastructure in place to ensure no unethical research is done, and the kinds of organisms that are allowed in laboratories. The focus now, according to Dr. Silver, is on technology to ensure safety. When scientists build synthetic microbes, they can program in mechanisms called kill switches that cause the microbes to self-destruct if their environment changes in certain ways.

Microbial sensors and drug delivery systems can be shown to work in the lab, but researchers are not yet sure how they will function in a human body or a large-scale bioreactor. Engineered organisms have huge potential, but they will only be useful if proven to be reliable, predictable, and cost effective. Today, engineered bacteria are already in clinical trials for cancer, and this is just the beginning, says Dr. Silver.

"The rate at which this field is moving forward is incredible. I don't know what happened - maybe it's the media coverage, maybe the charisma - but we're on the verge of something very exciting. Once we've figured out how to make genomes more quickly and easily, synthetic biology will change the way we work as researchers, and even the way we treat diseases."

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Read the story on Elsevier Connect

Article details

"Synthetic biology expands chemical control of microorganisms" by Tyler J Ford and Pamela A Silver (doi: 10.1016/j.cbpa.2015.05.012). The article appears in Current Opinion in Chemical Biology, Volume 28 (October 2015), published by Elsevier.

News Release Source : Synthetic biology needs robust safety mechanisms before real world application

Ecological Risk Research Agenda for Synthetic Biology

An Ecological Risk Research Agenda for Synthetic Biology

Report Developed by the Ecological Community Highlights Priority Research Areas

WASHINGTON, May 29, 2014 /PRNewswire-USNewswire/ -- Environmental scientists and synthetic biologists have for the first time developed a set of key research areas to study the potential ecological impacts of synthetic biology, a field that could push beyond incremental changes to create organisms that transcend common evolutionary pathways.

[caption id="attachment_200" align="alignleft" width="600"] Ecological Risk Research Agenda for Synthetic Biology[/caption]

The Synthetic Biology Project at the Wilson Center and the Program on Emerging Technologies at the Massachusetts Institute of Technology convened the interdisciplinary group of scientists and are releasing the report, Creating a Research Agenda for the Ecological Implications of Synthetic Biology. The work was funded by a grant from the National Science Foundation (NSF).

"We hope this report raises awareness about the lack of research into these ecological issues," says Dr. James Collins, Ullman Professor of Natural History and the Environment at Arizona State University and former Director of the Population Biology and Physiological Ecology Program and Assistant Director of Biological Sciences at NSF. "We involved experts in the ecological research and synthetic biology communities to help identify priority research areas – and we believe the report can be a roadmap to guide the necessary work. The rapid pace of research and commercialization in the field of synthetic biology makes it important to begin this work now."

The report prioritizes key research areas for government agencies, academia and industry to fund. Research areas include species for comparative research; phenotypic characterization; fitness, genome stability and lateral gene transfer; control of organismal traits; monitoring and surveillance; modeling and standardization of methods and data.

In developing the report, various applications were used to stimulate discussion among synthetic biologists, ecologists, environmental scientists and social scientists, as well as representatives from government, the private sector, academia, environmental organizations and think tanks. Applications considered in the process included bio-mining; nitrogen fixation by engineered crops; gene drive propagation in populations of invasive species; and engineered seeds and plants destined for distribution to the public.

The report says it is necessary to establish and sustain interdisciplinary research groups in order to conduct the research. Long-term support is also needed to address complex questions about how synthetic biology could impact the environment and overcome communication barriers across disciplines, the report says.

The report can be downloaded from the Synthetic Biology Project website:http://www.synbioproject.org/library/publications/archive/6685/

About the Synthetic Biology Project
The Synthetic Biology Project is an initiative of the Woodrow Wilson International Center for Scholars supported by a grant from the Alfred P. Sloan Foundation. The Project aims to foster informed public and policy discourse concerning the advancement of synthetic biology. For more information, visit: http://www.synbioproject.org

About the MIT Program on Emerging Technologies
The Center for International Studies (CIS) aims to support and promote international research and education at MIT. The CIS Program on Emerging Technologies (PoET) seeks to improve responses to implications of emerging technologies. PoET was created with support of an NSF IGERT. Research has included retrospective studies on past emerging technologies led byMerritt Roe Smith, Larry McCray and Daniel Hastings, as well as prospective studies on next-generation internet (led by David D. Clark) and synthetic biology (led by Kenneth A. Oye). For more information, visit: http://web.mit.edu/cis/

About The Wilson Center
The Wilson Center provides a strictly nonpartisan space for the worlds of policymaking and scholarship to interact. By conducting relevant and timely research and promoting dialogue from all perspectives, it works to address the critical current and emerging challenges confronting the United States and the world. For more information, visit: http://www.wilsoncenter.org

 SOURCE Synthetic Biology Project

News Release Source :  An Ecological Risk Research Agenda for Synthetic Biology

Challenges and Options for Oversight of Organisms Engineered Using Synthetic Biology

Venter Institute-Led Policy Group Publishes Report on Challenges and Options for Oversight of Organisms Engineered Using Synthetic Biology Technologies

ROCKVILLE, Md. and SAN DIEGO, May 28, 2014 /PRNewswire/ -- Policy researchers from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO today released a report detailing the challenges faced by regulators with the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes and some options for dealing with these challenges.

[caption id="attachment_196" align="alignleft" width="300"] Challenges and Options for Oversight of Organisms Engineered Using Synthetic Biology[/caption]

The authors conclude that while the United States governmental agencies tasked with oversight of products derived through synthetic biology have adequate legal jurisdiction to address most, but not all, environmental, health and safety concerns, several key issues could challenge these agencies including: the advent of newer plant engineering technologies that are outside the authority of some agencies, and increased use of more complex engineered microbes that could overwhelm regulators both from a science and safety review and increasing cost perspective.

Genetic engineering to make relatively minor manipulations of small numbers of genes in plants, microbes, and animals has been utilized in science and biotechnology to develop products since the 1980s. Three agencies are tasked with oversight of genetically engineered organisms—the US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA). Through the years these agencies have successfully reviewed products for potential environmental, health and safety concerns, and have also issued regulations and industry guidelines.

Over the last five years breakthroughs and advances in the new field of synthetic biology—the newest generation of genetic engineering—are enabling construction and synthesis of whole genes and genomes opening even more new avenues for product development in many industries including new food and nutritional products, vaccines and pharmaceuticals, and biofuels.

With these advances in mind, the JCVI led team examined how well APHIS, EPA, and FDA will be able to review the potential rapid increase of new plants and microbes developed using synthetic biology. They found areas of concern and offered the following options for oversight.

Genetically Engineered Plants
APHIS has reviewed engineered plants for the past 25 years. This authority is based on genetic engineering technology that uses plant pests or some component of plant pests. Synthetic biology is accelerating development and use of new genetically engineered plants that fall outside APHIS' purview and thus without regulatory review before potential use in the environment.  The authors outline the following options:

1. Maintain existing regulatory system and rely on a voluntary approach for those genetically engineered plants not subject to review.


2. Identify the most likely risks from newer plant biotechnology and apply existing laws that would best mitigate them.


3. Give APHIS additional authority to review and regulate genetically engineered plants.


4. Distribute rules under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) or the Toxic Substances Control Act (TSCA) for EPA to regulate engineered plants.

Genetically Engineered Microbes
Synthetic biology is enabling a larger number of increasingly more complex engineered microbes for commercial use, particularly those intended for use in the open environment. This influx may overwhelm the EPA's Biotechnology Program both from an expertise and funding perspective. The policy team outlined the following options for consideration to help alleviate any regulatory delays or deficiencies for microbial products:

1. If and when needed, provide additional funding for EPA's Biotechnology Program under TSCA and pursue efficiency measures to expedite reviews.


2. Amend TSCA to strengthen EPA's ability to regulate engineered microbes.

"Synthetic biology offers great promise for a new and improved generation of genetically engineered microbes, plants, and animals," said Robert Friedman, Ph.D., JCVI's Vice President for Policy.  "To achieve this promise, the public must be assured that the U.S. regulatory agencies are able to review these products as effectively as they have over the past two decades.  Our report identifies several issues and options for policymakers to update the current U.S, regulatory system for biotechnology."

The report is funded by the United States Department of Energy Office of Biological and Environmental Research with additional support from the Sloan Foundation. Authors of the report are: Sarah R. Carter, Ph.D., JCVI; Michael Rodemeyer, J.D.,University of Virginia, Michele S. Garfinkel, Ph.D., EMBO, Germany, Robert M. Friedman, Ph.D., JCVI. The full report can be downloaded here:   http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-system/

About the J. Craig Venter Institute (JCVI)
The JCVI is a not-for-profit research institute in Rockville, MD and San Diego, CA dedicated to the advancement of the science of genomics; the understanding of its implications for society; and communication of those results to the scientific community, the public, and policymakers. Founded by J. Craig Venter, Ph.D., the JCVI is home to approximately 250 scientists and staff with expertise in human and evolutionary biology, genetics, bioinformatics/informatics, information technology, high-throughput DNA sequencing, genomic and environmental policy research, and public education in science and science policy. The legacy organizations of the JCVI are: The Institute for Genomic Research (TIGR), The Center for the Advancement of Genomics (TCAG), the Institute for Biological Energy Alternatives (IBEA), the Joint Technology Center (JTC), and the J. Craig Venter Science Foundation. The JCVI is a 501 (c)(3) organization. For additional information, please visit http://www.JCVI.org.

 SOURCE J. Craig Venter Institute

News Release Source :  Venter Institute-Led Policy Group Publishes Report on Challenges and Options for Oversight of Organisms Engineered Using Synthetic Biology Technologies

Synthetic Biology Still in Uncharted Waters of Public Opinion

Synthetic biology still in uncharted waters of public opinion

Focus group concerns centered on specific applications of the technology

The Synthetic Biology Project at the Woodrow Wilson International Center for Scholars is releasing the results of a new set of focus groups, which find continued low awareness of synthetic biology among the general public.

The focus groups also sought opinions on the emerging field of neural engineering.

The focus group results support the findings of a quantitative national poll conducted by Hart Research Associates in January 2013, which found just 23 percent of respondents reported they had heard a lot (6 percent) or some (17 percent) about synthetic biology.

The focus group discussions also reinforce earlier findings that specific applications impact people's hopes and anxieties around synthetic biology. For example, medical applications including disease cures gained the most support in the focus groups, while the biological production of chemicals and food additives received little to no support.

Participants focused their concern on unforeseen, unintended consequences that might occur from synthetic biology. There was a clear and strong desire to study and monitor the potential risks of synthetic biology, which may require a variety of organizations.

For the first time, the focus groups also sought opinions on neural engineering – an area of science that uses engineering and brain science to build devices to support brain control of prosthetic or robotic devices in humans. In contrast to synthetic biology, participants in these sessions found few downsides to neural engineering applications that could help people with motor disabilities or who have lost a limb.

To the extent unease surfaced about neural engineering, participants were concerned about inequitable access to the technologies. There was little concern about the adverse consequences of neural engineering beyond the individual patient, unlike applications of synthetic biology, which participants feared could have much broader implications for society and the environment.

Because this is qualitative research among only a small number of individuals, the findings from these two focus groups cannot be generalized to represent the entire population of adults in the United States. Rather, these qualitative findings provide context for evaluating the 2013 survey findings and depth of understanding about how these audiences respond to these areas of science and their potential applications.

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The focus groups were conducted in Maryland in April 2014. The full report and video clips from the focus groups, as well as the 2013 survey report, can be found here: http://www.synbioproject.org/news/project/6683/

About the Synthetic Biology Project

The Synthetic Biology Project is an initiative of the Woodrow Wilson International Center for Scholars supported by a grant from the Alfred P. Sloan Foundation. The Project aims to foster informed public and policy discourse concerning the advancement of synthetic biology. For more information, visit: http://www.synbioproject.org

About The Wilson Center

The Wilson Center provides a strictly nonpartisan space for the worlds of policymaking and scholarship to interact. By conducting relevant and timely research and promoting dialogue from all perspectives, it works to address the critical current and emerging challenges confronting the United States and the world. For more information, visit: http://www.wilsoncenter.org

News Release Source :  Synthetic biology still in uncharted waters of public opinion

The Societal Impacts of Synthetic Biology

The Societal Impacts of Synthetic Biology

Online Survey Seeks Public Input into Prioritizing Action

Washington, D.C. (PRWEB) March 15, 2012

The Woodrow Wilson International Center for Scholars is soliciting public opinion on the most critical ethical, legal, and social implications (ELSI) for synthetic biology in a new online survey, which will provide guidance as federal agencies, foundations, industry, NGOs, and other stakeholders with limited resources seek to address key ELSI concerns.

[caption id="attachment_79" align="aligncenter" width="500"] The Societal Impacts of Synthetic Biology[/caption]

The online survey asks respondents to rate a number of actions that could address ELSI issues, such as ensuring long-term effects of synthetic biology are benign, tracking public and private investment in the field, or labeling products that include synthetic biology in their manufacture. By prioritizing these potential actions, resources can be better focused on areas of public concern. The results of this anonymous survey will be analyzed and compiled into a report, which will be released in mid- to late-May 2012.

To take the survey, please visit: https://docs.google.com/spreadsheet/viewform?formkey=dERxQ1F5b1RKX3hDTC0xVnRRaWk3Q2c6MA

This survey builds on a workshop held Nov. 8-9, 2010, at the Wilson Center in Washington, D.C. The workshop culminated in a July 2011 report, Issues Arising from Synthetic Biology: What Lies Ahead?, which identified potential challenges and pressing research needs. More information and a link to the report can be found here:http://www.synbioproject.org/events/archive/what_lies_ahead/

The workshop was sponsored by the Wilson Center, the Department of Energy, and the Alfred P. Sloan Foundation. Following the workshop, an online survey was conducted to gather further input about which ELSI issues should be considered in the context of synthetic biology. The list of priorities in the new survey integrates the workshop-generated ideas with the post-workshop online input.

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Synthetic Biology Project 

The Synthetic Biology Project is an initiative of the Woodrow Wilson International Center for Scholars supported by a grant from the Alfred P. Sloan Foundation. The Project aims to foster informed public and policy discourse concerning the advancement of synthetic biology. For more information, visit: http://www.synbioproject.org

Woodrow Wilson International Center for Scholars
The Woodrow Wilson International Center for Scholars is the national, living memorial honoring President Woodrow Wilson. The Wilson Center provides a strictly nonpartisan space for the worlds of policymaking and scholarship to interact. By conducting relevant and timely research and promoting dialogue from all perspectives, it works to address the critical current and emerging challenges confronting the United States and the world. Created by an Act of Congress in 1968, the Wilson Center is a non-partisan institution headquartered in Washington, D.C. and supported by both public and private funds. For more information, visit:http://www.wilsoncenter.org/

Source : http://www.prweb.com/releases/2012/3/prweb9281377.htm

The Governance of Synthetic Biology

The Governance of Synthetic Biology

Are We Making Progress?

WASHINGTON, Feb. 8, 2012 /PRNewswire-USNewswire/ -- The Synthetic Biology Project at the Woodrow Wilson Center is launching a new web-based Synthetic Biology Scorecard, designed to track federal and non-federal efforts to improve the governance of synthetic biology research and development so risks are minimized and broad social and economic benefits can be realized.

The Scorecard, unveiled today, monitors the progress made toward implementing the recommendations in New Directions: The Ethics of Synthetic Biology and Emerging Technologies, a December 2010 report from the Presidential Commission for the Study of Bioethical Issues. The report contains 18 recommendations covering a range of topics from risk assessment to ethics education and public engagement.

[caption id="attachment_83" align="aligncenter" width="300"] The Governance of Synthetic Biology[/caption]

More than a year has passed since the release of the Commission's report. What progress has been made? The Scorecard seeks to answer that question: In addition to tracking the progress of various federal and non-federal initiatives, the website encourages broad participation in achieving the goals set forth by the Commission and invites public comment on the recommendations and implementation efforts.

"The Commission's report was a landmark document and lays out a framework with broad applicability to many emerging technologies, but, like many reports of this type, no mechanisms were put in place to track progress," David Rejeski, director of the Synthetic Biology Project, said. "Our goal is ensure that this report -- and others like it – can drive change."

Valerie Bonham, executive director of the Commission, said, "Throughout the Commission's deliberations and in the report, the members emphasized the need for transparency, dialogue, and accountability around synthetic biology."

President Obama requested the Commission's report almost two years ago in response to important advancements in the field of synthetic biology. On May 20, 2010, scientists at the J.C. Venter Institute unveiled a bacterial cell controlled by a synthetic genome. That same day, the president asked the Commission to undertake "a study of the implications of this scientific milestone . . . [and] consider the potential medical, environmental, security, and other benefits of this field of research, as well as any potential health, security, or other risks."

Following the launch of the Scorecard, the Synthetic Biology Project will update the website to reflect new initiatives and publish a bi-annual summary of federal and non-federal activities that fulfill the recommendations. Additions to the Scorecard are welcome and encouraged.

The Synthetic Biology Scorecard can be found here: http://www.synbioproject.org/scorecard/

The Woodrow Wilson International Center for Scholars

The Woodrow Wilson International Center for Scholars is the national, living memorial honoring President Woodrow Wilson. The Wilson Center provides a strictly nonpartisan space for the worlds of policymaking and scholarship to interact. By conducting relevant and timely research and promoting dialogue from all perspectives, it works to address the critical current and emerging challenges confronting the United States and the world. Created by an Act of Congress in 1968, The Wilson Center is a non-partisan institution headquartered in Washington, D.C. and supported by both public and private funds.

SOURCE Woodrow Wilson Center

News Release Source :  The Governance of Synthetic Biology