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2 Industrial Biotechnology: Past and Present
Pages 25-52

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From page 25...
... by creating new skills and jobs to benefit today's and tomorrow's generations. Accelerating advanced chemical manufacturing by industrializing biology can drive the rapid growth of an innovative U.S.
From page 26...
... economic activity, while biofuels added another $30 billion. Lux Research estimates that industrial chemicals made through synthetic biology currently represent a $1.5 billion market and that this likely will expand at 15 to 25 percent annual growth rates for the foreseeable future.3 A recent U.S.
From page 27...
... GDP." 25 The global market for enzymes used in consumer products and industrial production processes -- and a prime target for the industrialization of biology -- alone is expected to reach $8 billion by 2015. The OECD has projected that industrial biotechnology and bio-based chemical manufacturing likely will accelerate and lead the development
From page 28...
... This figure provides key examples of successful chemical manufacturing through biological routes.
From page 29...
... A study from BCC Research suggests that synthetic biology markets for chemicals will grow to $11 billion by 2016,24 and a broader review from McKinsey Global Institute estimates that synthetic biology and the industrialization of ­ iology will b provide a disruptive set of technologies with an economic impact of at least $100 billion by 2025.26 As a result, the broad applications of advanced chemical manufacturing for multiple uses in energy, health, advanced consumer products, agriculture and food, cosmetics, and environmental technologies are expected to produce trillions of dollars in addressable global market opportunities. Several recent studies estimate that at least 20 percent of today's petrochemical production can be replaced by the industrialization of biology in chemical manufacturing over the next decade.25 Aside from the large size of the chemical markets that can be addressed biologically, making biology easier to engineer and developing new chemical manufacturing capabilities based on synthetic biology will have a broad range of other economic benefits.
From page 30...
... New business models are proliferating, as are innovative collaborations, driven by advances in synthetic biology. University-industry linkages span the continuum from high-risk basic research to late-stage prototype development projects that can scale and compete at market-driven price and performance points.
From page 31...
... This new integration would provide the basis for not only new economic growth but also the tools and platforms for addressing many of the major global grand challenges of this century. In 2011, a Massachusetts Institute of Technology (MIT)
From page 32...
... An emerging metaphor from convergence is that of the "cell as tomorrow's factory." As Neri Oxman from the MIT Media Lab observed, "The biological world is displacing the machine as a general model of design."30 In short, the industrialization of biology and synthetic biology will be as important for the next 50 years as semiconductors and related information and communication devices have been to economic growth over the past 50 years. Societal Benefits in Addressing Global Grand Challenges When compared to traditional manufacturing, advanced manufactur­ ing of chemicals through biology might produce social benefits while requiring fewer trade-offs between growth and sustainability.
From page 33...
... A driver for the transition to the bioeconomy and novel advanced chemical manufacturing is the anticipation by some energy experts, such as the International Energy Agency, that oil, gas, and coal "will reach peak production in the not too distant future and that prices will climb." The OECD recently demonstrated that the scope and platforms for the biobased production of chemicals and fuels increased significantly in 2013. Its analysis concludes that these developments "may open the door to greater replacement of the oil barrel."31 Climate Change and Environmental Sustainability The advanced manufacturing of bio-based chemicals could provide numerous environmental benefits.
From page 34...
... Additional environmental benefits will be related to using synthetic biology and related techniques for bio­ remediation that can bring contaminated soil back into productive use. The OECD notes that the world's soil is being lost 18-30 times faster than it is formed, and that new methods such as synthetic biology are important for limiting soil destruction and for growing crops more efficiently.
From page 35...
... The Time is Right: Current State and Advances in Science AND Industry Opportunities Arising from DNA Technologies, Systems Biology, Metagenomics, and Synthetic Biology Biology has the potential to build intricate material and chemical structures with atomic precision. Biotechnology has only begun to harness this capability, and leading-edge products in development have simple structures, such as butanediol, isobutanol, farnesene, and lactic acid.
From page 36...
... The most valuable functions require many genes and complex regulatory control over how much, when, and where they are turned on. Synthetic biology offers some tools to tackle this challenge, including genetic circuits, precision regulatory parts, and computer-aided design to systematically recode multigene systems.35 While it is possible to synthesize entire genomes, we are far from being able to write them from scratch from the bottom up.
From page 37...
... provide the standards for characterizing genetic parts, reporting construction precision, and software integrating -omics data. 42 New High-Value Chemical Products Unobtainable by Traditional Chemical Synthesis Organic synthesis is a mature discipline where nearly any target molecule can be made through a logical combination of reaction steps.
From page 38...
... Fully accessing their chemical products will require a further reduction in synthesis costs and the application of synthetic biology to control multigene systems and functionally transfer activity to new organisms. Collectively, the mining efforts are yielding a deluge of new enzyme data across entire families that encompass activity and specificity information.
From page 39...
... productive host organisms enabled the use of methods such as classical mutagenesis that required neither complete understanding of the underlying biochemical pathways nor knowledge of the genes encoding the constituent enzymes in order to enhance productivity. In the three decades that followed, fermentation processes were developed for large-scale commercial production of several additional products including citric acid, vitamin B12, glutamic acid, and lysine.
From page 40...
... This challenge and the discipline that emerged to address it was first codified in Toward a Science of Metabolic Engineering by James E Bailey.52 Metabolic engineering sought to take advantage of the tools of recombinant DNA technology while applying systems and network analyses to the challenge of engineering more productive strains.53 These principles were successfully applied to generate highly efficient and productive fermentation processes for a number of products, including, for example, 1,3-propanediol and lysine from an engineered strain of E
From page 41...
... While bio-based chemical production from whole-cell organisms was being advanced, the tools of biotechnology were also being applied in other arenas. Of note is the use of genetic engineering in agriculture.
From page 42...
... In the case of sitagliptin, a molecule produced through collaboration between Merck and Codexis, the optimized use of a bio­ atalytic step to replace an analo c gous chemical one in the process resulted in reduction in the ratio of total mass of materials used to mass of isolated product from 37 to 6.55 The key drivers for a company using bio-based methods for chemical production can vary greatly based on the products being manufactured. Under ideal circumstances, an analysis of the margin on a series of products would allow us to understand the economic drivers that are most relevant to their production processes.
From page 43...
... 60 The production of semisynthetic artemisinin is one of the first success stories for the combined use of metabolic engineering and synthetic biology in the production of a pharmaceutical at industrial scale (see Figure 2-3)
From page 44...
... Yeast is an attractive host organism because of its robustness, extensive fermentation knowledge, availability of genetic tools, tolerance to industrial conditions and solvents (butanol tolerance >20 g/L) , low media pH, and lack of susceptibility to bacteriophage.20 Yeasts' main limitations are an inability to digest C5 sugars, such as xylose and arabinose, which are present in lignocellulosic biomass; a natural ability to produce ethanol, which may hinder metabolic engineering efforts to produce advanced biofuels; limited synthetic biology tools for pathway optimization; and
From page 45...
... One strategy being c pursued by Butamax is to construct many different metabolic pathways leading to butanoyl.67 Finally, Butalco, which has strains that metabolize C5 sugars, proposes to use only endogenous genes to improve isobutanol production.68 Technologies exploiting fatty acid metabolism are pursuing a variety of host organisms.
From page 46...
... At this stage biomass-based sugars are challenged to meet the cost and quality needed to produce polymer intermediates. C1 feedstocks look attractive, but today face major challenges for engineering production strains and for production process technology.
From page 47...
... R., Rodemeyer M., Garfinkel M.S., and Friedman R.M. Synthetic Biology and the U.S.
From page 48...
... For the governance framework to have legitimacy in the eyes of the public and the industry, it should be perceived as fair, transparent, effi
From page 49...
... OSHA does not have regulations specific to work with engineered organisms, but it does require that employers create a workplace free from serious, recognized hazards, and it lays out principles and precautions for working with hazardous chemicals. The overlap of legal regimes, and the uncertainty over how and whether regimes will apply to complex engineered organisms, can lead to uncertainty that may hinder
From page 50...
... However, despite the multiple statutory authorities under whom agencies can regulate industrial biology, the existing legal regimes may fail to adequately address some foreseeable risks. Neither the EPA nor USDA-APHIS regulates production processes, and both focus most of their biotechnology-specific regulation on the "premarket" phase of the product life cycle.ii It is, therefore, unclear whether these agencies have adequate authority or expertise to ensure that proper containment and disposal procedures will be used at commercial manufacturing facilities once a manufacturer engages in legal commercial production of a biologically produced chemical.
From page 51...
... Biosafety and biosecurity gene sequence screening approaches can readily be incorporated into the inte grated design toolchain. Although IGSC's protocol does not enable companies to identify and predict problematic biosafety and biosecurity properties that emerge when multiple components come together in an organism or bioprocess, it does when an individual component is of concern.
From page 52...
... To promote the industrialization of biology, academic and industry scientists in synthetic biology and related fields will need to determine an acceptable balance between open and proprietary approaches to innovation. Related to balancing open and proprietary science is the increasingly prevalent practice of data sharing.


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