This report has described the structure of the current chemical manufacturing process and explored the promise of increased application of biological processes to chemical production. Lowered costs, increases in production speed, flexibility of manufacturing plants, and increased production capacity are among the many potential benefits that the increased industrialization of biology may bring to producers and consumers of chemical products. As outlined in Chapter 2, the production of chemicals through biological processes may help to reduce toxic by-products, to reduce greenhouse gas emissions, and to lower fossil fuel consumption in chemical production. The advanced manufacturing of chemicals through biology can help address global challenges related to energy, climate change, sustainable and more productive agriculture, and environmental sustainability.
Realizing the significant benefits of the continued and more efficient industrialization of biology requires the sustained effort of multiple stakeholders. This chapter offers several recommendations to specific stakeholders designed to facilitate the achievement of the technical milestones detailed in Chapter 4.
Additionally, recognizing the significant role that societal factors will play in the continued industrialization of biology, this chapter puts forth recommendations focused on the impact of economics, education and workplace issues, and governance in facilitating the industrialization of biology. This chapter addresses these societal factors and offers sev-
eral recommendations to foster the achievement of critical societal goals related to the industrialization of biology.
Ensuring the rapid industrialization of biology will require, one, the selection of advantageous chemicals, materials, and fuel targets, based on technical and economic criteria as well as social benefits as embodied in governance criteria; two, the development of broader and deeper scientific understanding in support of the industrialization of biology; and three, engagement with the public at large who are impacted by the acceleration of this industry. The recommendations presented in this chapter are designed to address each of these three factors, with the ultimate goal of putting biological synthesis and engineering on par with chemical synthesis and engineering for chemical manufacturing.
Realization of the promise of the industrialization of biology for chemical manufacturing can only be achieved through a sustained effort among multiple stakeholders. The challenge is even more daunting in an era of fiscal austerity, of technological complexity, and of regulatory uncertainty. To meet the Statement of Task, the Committee has constructed a roadmap based on a current view of technology, markets, and societal considerations. Any roadmap is accurate only at a point in time. In a fast-evolving field, a roadmap can only remain useful if it is updated at some frequency. As a result, the Committee believes it is essential to create a mechanism that provides for an ongoing road-mapping process.
The UK recently established the Synthetic Biology Leadership Council (SBLC) to maintain the momentum of the UK Synthetic Biology Roadmap. The UK SBLC has representatives from multiple stakeholder groups, including government, academia, and industry. In 2012, Research Councils UK convened a coordination group to oversee the creation of the UK Synthetic Biology Roadmap. Subsequently, the UK government instituted the SBLC as a steering structure governance body to assess progress and update recommendations and shape priorities for future implementation of the roadmap in the UK. The SBLC provides a visible point for strategic coordination between the funding agencies, the research community, industry, government sponsors, and other stakeholders, including societal and ethical representatives.
Within the United States, Synberc is a multi-university research center established in 2006 with a grant from the National Science Foundation (NSF) to help lay the foundation for synthetic biology. Eighteen institutions are currently involved. Synberc has also added nearly 50 industrial partners. Its mission does not include roadmapping, but it does focus on the foundational science and technology for synthetic biology, as well as
capability-building and public engagement. Synberc is a potential model for taking on the ongoing roadmapping work
One successful example of roadmapping in another technology area is Sematech. Dating back nearly 30 years, Sematech was founded as a consortium between the U.S. government and the American semiconductor industry, with some initial funding from DARPA (Defense Advanced Research Projects Agency). Among its important functions was the maintenance of the technology roadmap for semiconductors. Since its founding, Sematech has evolved to a global industry consortium, fully funded by its members.
The Committee recommends that the relevant government agencies consider establishment of an ongoing roadmapping mechanism to provide direction to technology development, translation, and commercialization at scale. This roadmapping effort would bring together participants from public and private research, and participants with all skill sets needed for the industrialization of biology. In addition to maintaining the roadmap, this effort could assist in sharing the knowledge, tools, and data needed to accelerate progress. It is recognized that a number of well-functioning processes and organizations are already meeting needs in industrialization of biology, and the suggested roadmapping effort would not usurp the existing mechanisms, but would help to coordinate these activities with other elements. Moreover the roadmapping effort could help to address a set of difficult, core technical challenges that must be overcome. It might help to develop, share, and diffuse common interoperable standards, languages, and measurements. Roadmapping would also assist in prioritizing efforts for creating new enabling tools or data.
The lessons learned from roadmaps and consortia in comparable domains demonstrate that well-designed and well-executed strategic processes can accelerate time frames, help prioritize objectives, and make the industrialization more transparent, responsible, and accessible.
The Committee recognizes that any decisions on a roadmapping process would be within the purview of the interested federal agencies. Based on the UK experience, it would be possible to have a functioning process within 2 years. Within 5 years, such an effort could contribute materially to our national capability to develop and scale up bioprocesses for the manufacture of chemicals. Within 10 years, one can foresee the broad diffusion and acceptance of bioprocessing as a core foundation of the chemical economy, of advanced manufacturing, and of American competitiveness in the bioeconomy.
pathway design, and measurement techniques. Achieving these milestones will take predictable and consistent investment to develop the scientific knowledge and technical tools.
Conclusion: Biomanufacturing of chemicals is already a significant element of the national economy and is poised for rapid growth during the next decade. Both the scale and scope of biomanufacturing of chemicals will expand and will involve both high-value and high-volume chemicals. Progress in the areas identified in this report will play a major role in achieving the challenge of increasing the contribution of biotechnology to the national economy.
Recommendation: In order to transform the pace of industrial biotechnology by enabling commercial entities to develop new biomanufacturing processes, the National Science Foundation (NSF), Department of Energy, National Institutes of Health, National Institute of Standards and Technology, Department of Defense, and other relevant agencies should support the scientific research and foundational technologies required to advance and integrate the areas of feedstocks, organismal chassis and pathway development, fermentation, and processing as outlined in the roadmap goals.
Supporting foundational research in these areas is critical to the growing commercial viability of biological processes in chemical manufacturing. Specifically, it is recommended that these agencies support research focused on the following:
- Improving the availability of economic and environmentally sustainable feedstocks;
- Increasing the availability, reliability, and sustainability of biofeedstocks, in order to increase the range of economically viable products, provide more predictive levels and quality of feedstock, and lower barriers to entry into the biological production of chemicals;
- Improving the basic understanding of C1-based fermentation, in light of the increased availability of natural gas in the United States;
- Improving the productivity of the fermentation process, by means of enhanced mass and heat transfer, continuous product removal, more extensive use of co-cultures, co-products, and co-substrates, where continued development of fundamental science and enabling technologies is required for the rapid and efficient development of organismal chassis and pathways;
- Expanding the palette of domesticated microbial and cell-free platforms for biomanufacturing;
- Cultivating robust strains that remain genetically stable and retain performance stability over time in the presence of diverse feedstocks and products;
- Developing the ability to rapidly develop enzymes with respect to catalytic activity and specific activity; and
- Rapidly, routinely, and reproducibly measuring pathway function and cellular physiology.
This list is not intended to be exhaustive but rather to highlight those areas that are most directly related to the technical roadmap goals.
Meeting the technical and scientific challenges involved in the industrialization of biology is necessary to realize the potential benefits, but ensuring that those benefits accrue rapidly and with maximum positive impact requires accurate and detailed information about the role of bio-based production in the economy. The ability to predict economic trends, to assess economic impact, and to more completely understand the role of bio-based products in the economy will enable better decision making for all stakeholders involved in the industrialization of biology.
Recommendation: The U.S. government should perform a regular quantitative measure of the contribution of bio-based production processes to the U.S. economy to develop a capacity for forecasting and assessing economic impact.
Improved quantitative measures of the impact of bio-based production will be valuable to a range of stakeholders, but these measures will directly affect both policy makers and business leaders: policy makers will be better able to set budget estimates and projections, and business leaders will be better able to assess market size and direction. By measuring this area of economic activity, those involved will be able to make more informed decisions, potentially leading to significantly increased efficiency.
The industrialization of biology will create new structures of work, place new skills in demand, and necessitate the development of new
expertise in the biological and chemical sciences, engineering, and computing in the workforce. Changing workforce demands will require changes in education and training.
Recommendation: Industrial biotechnology firms individually, and especially through industry groups, should strengthen their partnerships with all levels of academia, from community colleges, undergraduate institutions, and graduate institutions, to communicate changing needs and practices in industry in order to inform and influence academic instruction.
Without communication and partnership between academia and industry, skills that are emphasized in academia may not be useful or valued in industry. Developing balanced training portfolios for technicians, subject-matter experts, and biological designers is important, but is only possible through the active engagement of both industry and academic institutions. The aforementioned collaboration framework can likely be one mode by which these connections are facilitated.
Affording students the opportunity to experience industrial lab settings carries significant benefits to both students and future employers. The ability to plan for large-scale production and skill in developing significant scientific results into tangible, useful products are critical capabilities that the present and future chemical manufacturing demands. Ensuring that academia is providing students with the ability to function in both academic and industrial settings requires the active participation of both industry and academia.
Biology is already playing a large role in chemical manufacturing in the United States. Chemical manufacturers utilizing bio-based processes can help to develop the workforce necessary for the future structure of chemical manufacturing. By encouraging the training of a skilled workforce prepared to work in this emerging field, students and trainees should have the opportunity to explore the field early in their academic careers.
Recommendation: Federal agencies, academia, and industry should devise and support innovative approaches toward expanding the exposure of student trainees to design-build-test-learn paradigms in a high-throughput fashion and at industrial scale.
The needs and tools of industry are rapidly changing. Chemical production at very large scales and with extensive automation is frequently very distinct from academic experience. Partnerships between universities and industry will allow students and trainees to be exposed to the
concerns, techniques, and needs of industry, which will help to create a workforce better prepared to think and function in this new economic environment.
The impact of the industrialization of biology on society will be mediated by a governance framework. Ensuring that this framework balances important social values is critical. In order to do so, a governance framework should involve a variety of policy approaches, including education, self-governance through standard setting, accreditation, government regulation, public engagement and public scrutiny, and tort liability, among other methods.
Safety, sustainability, security, and resilience are critical goals for any governance framework. These values sometimes cause tension and any governance framework will have to balance these competing demands. In order to do so, a governance framework must have legitimacy in the eyes of the public and the industry. To be successful, a governance framework should be perceived as fair, transparent, efficient, and inclusive of diverse viewpoints.
Recommendation: The administration should ensure that the Environmental Protection Agency (EPA), Commerce Department, U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA), Occupational Safety and Health Administration, National Institute of Standards and Technology (NIST), and other relevant agencies work together to broadly assess, and regularly reassess, the adequacy of existing governance, including but not limited to regulation, and to identify places where industry, academia, and the public can contribute to or participate in governance.
Recommendation: Science funding agencies and science policy offices should ensure outreach efforts that facilitate responsible innovation by enabling the extension of existing relevant regulatory practices, concordance across countries, and increased public engagement.
Coordination across government bodies, combined with a commitment to transparency and public contribution and participation, will enable a governance framework that is at once navigable, perceived as legitimate, and achieves the societal goals critical to the public welfare.
Moreover, the governance framework established should be capable of gathering and utilizing information about the risks posed by new techniques and products.
Recommendation: Government agencies, including EPA, USDA, FDA, and NIST should establish programs both for the development of fact-based standards and metrology for risk assessment in industrial biotechnology and for the use of these fact-based assessments in evaluating and updating the governance regime.
The industrialization of biology offers the prospect of addressing global as well as American national interests. The recommendations put forward are designed to facilitate the achievement of the roadmap goals and, ultimately, the challenge posed by the committee: to double the percentage of gross domestic product that comes from the bioeconomy by putting biological synthesis and engineering on par with chemical synthesis and engineering for chemical manufacturing. It is important to note the urgency of these recommendations: scientific, technological, environmental, and economic trends are converging now that are creating positive conditions for the rapid industrialization of biology. Advanced chemical manufacturing through the industrialization of biology will require new tools, new knowledge, and new financial mechanisms. It promises new investment opportunities, new platforms for designing biological systems for next-generation American manufacturing, and opportunities to enhance competitiveness and create well-paying jobs.