Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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2 Emerging Trends and Products of Biotechnology
2 Emerging Trends and Products of Biotechnology
Pages 27-66
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From page 27... ...
For this reason, it is important to track changes in multiple areas that may affect product development and penetration rates. To help set the stage about who and what is influencing the development of new biotechnology products, this section gives a brief overview of a number of these drivers and some of their possible effects on regulation of future products of biotechnology.
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Standardized Biological Parts The field of synthetic biology has promoted the use of open-access, standardized parts for over a decade. The Registry of Standard Biological Parts1 was established at the Massachusetts Institute 1Registry of Standard Biological Parts.
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From page 29... ...
Millions of cells must be screened to identify those that are worth growing into genetically engineered microorganisms, plants, and animals. The advent of genome engineering -- which uses tools that allow rapid and precise changes di rectly across chromosomes of living cells instead of limited modifications at single genes using rDNA methods -- has transformed basic and applied biological research.
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. Leveraging these advances in genome engineering, synthetic biology has also been used to gener ate new products.
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ecreasing the design-build-test cycle length is a fundamental challenge facing all engineering disciplines. This is acutely true in synthetic biology." The designbuild-test-learn (DBTL)
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These are in turn enablers for better tools for predictive models that can be used in the design process, such as SimBiology,6 Clotho,7 and TinkerCell.8 Additional drivers that are not specific to future products of biotechnology but are nonetheless enablers of increasingly rapid product innovation are peer-to-peer sharing platforms such as Benchling,9 which provides software tools for software solution for experiment design, note taking, and molecular biology, or OpenWetWare,10 which provides an open wiki for synthetic biologists; "cloud-based" experimental platforms such as Transcriptic11 and Emerald Cloud Lab12 that provide access to advanced instrumentation and automation on a fee-for-service basis; and a variety of biotechnology incubator spaces, such as QB313 and LabCentral,14 that enable biotechnology startups to have access to advanced laboratory facilities. 4Systems Biology Markup Language.
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From page 33... ...
Although difficult to accurately determine, total domestic revenues in 2012 from biotechnology -- biological, agricultural, and industrial biotechnology products derived using genetically engineered (GE) organisms -- have been estimated to be at least $324 billion and to have grown at a rate of more than 5 percent of U.S.
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From page 34... ...
. Impact on Regulation The combination of new investments in biotechnology research, diversified sources of capital, and new players in the development of biotechnology products has the potential to create many new challenges for the biotechnology regulatory system.
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These trends include DIYbio community laboratories, at-home and direct-to-consumer biotechnology developers, crowdsourced funding and idea generation, and smaller-scale and decentralized manufacturing. Societal Drivers In addition to technical and economic drivers, there are a large variety of societal drivers that come into play in the context of both current and future products of biotechnology.
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From page 36... ...
. DIYbio community laboratories have already developed and adopted safety protocols and provide access to biosafety professionals via a Web-based portal.18 In addition to access to community laboratories, equipment, and biosafety professionals, the DIYbio community has increasing access to funding for their work through crowdfunding platforms, such as Kickstarter and Indiegogo, that allow public donations to support interesting projects.
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From page 37... ...
The difference in geographical distribution between 2013 DIYbio community adult survey respondents and 2015 iGEM student teams may foreshadow an increase in future biotechnology products with origins outside the United States. A large percentage of these products could be developed with the intention of export to the United States, which would further increase the number of products U.S.
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From page 38... ...
Examples of differing world views are most easily cited from experiences with agricultural biotechnology. Although commercially deployed GE crops have generally had favorable economic outcomes for adopters of these crops, outcomes for farmers are heterogeneous because the social and economic effects depend not only on the fit of the crop variety to the environment, but also on the institutional support available to the farmer, such as access to credit, affordable inputs, extension services, and markets (NASEM, 2016b)
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From page 39... ...
. This theory suggests that risk perception would become more negative due to anxiety-provoking factors associated with biotechnology products such as uncertainty, involuntary exposure, unfamiliarity, uncontrollability, and catastrophic risk; this has been shown to be true in some studies that include genetic engineering in comparison to other technologies (Slovic, 1987; Marris et al., 1998)
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From page 40... ...
Community and industry agreement on appropriate oversight frameworks and standards, even in the absence of explicit regulation, will be important for addressing how new products of biotechnology are evaluated. FUTURE BIOTECHNOLOGY PRODUCTS As a key element of the committee's charge, this section describes the future products of biotechnology and how their scope, scale, complexity, and tempo are accelerating.
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From page 41... ...
Input from companies at the committee's information-gathering meetings and surveys conducted by the Woodrow Wilson Center for International Scholars revealed that future products of biotechnology are quite diverse and make use of a wide variety of host organisms -- bacteria, fungi, plants, animals, and humans -- to serve a large number of markets such as health, energy, environment, food, and personal care (Munnelly, 2016; Peck, 2016; Reed, 2016; Sewalt, 2016; Stanton, 2016) .21 Work in advanced academic laboratories and an industry report indicate growing interest in in vitro technologies (BIO, 2016)
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From page 42... ...
. of biotechnology products in commerce as of 2016 -- such as crops genetically engineered to resist herbicides or insects -- were the result of the transformation of a well-characterized host organism, such as corn or soybean, with a few genes from another source organism that code for a desired trait, such as herbicide resistance along with a selectable marker gene to permit selection for transformed plants (Figure 2-6, column A)
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From page 43... ...
or EPA either.24 Between that decision in 2011 and December 2016, more than 40 GE plant products had been submitted to USDA–APHIS to determine if the product would fall outside the definition of a regulated article. Most have been determined to be outside the scope of USDA–APHIS's plant-pest authorities; however, the committee does not know which products have entered consumer markets.25 24See Chapter 3 for more discussion of the roles and responsibilities of the regulatory agencies and Appendix D for the Federal Food, Drug, and Cosmetic Act definition of food.
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From page 44... ...
The committee anticipated that a similar trend will be seen once the first genome-editing animal enters commerce. Advances in CRISPR-mediated genome editing have given rise to predictions of a wide range of precisely engineered animals including monkeys, mosquitoes, pigs, bees, cows, carp, dogs, ferrets, shrews, and chickens for an array of purposes including disease models, drug production, disease control, pets, food production, vector control, and behavioral studies (Reardon, 2016)
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. Anticipated future products include logical extensions of these products but also shift to products consisting of organisms whose genome could be largely synthetic, including both organisms with advanced genetic delimitation and those engineered to be capable of sustaining themselves in the environment.
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Arrows indicate that the committee anticipated that similar products or products using the same transformation technology (for example genome editing or gene drives) are likely to be developed.
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ü ü Animal Products Animals and Reduced-allergen goat's milk ü Landmine-detecting mice ü Animals revived from near extinction or extinction ü Animals with gene drives for control of invasive ü mammals Animals with gene drives for control of insect ü pests Biosensors/bioreporters ü Microbial Products Bioremediation ü Microbes and Engineered algal strains üüü Nitrogen-fixing symbionts ü Probiotics ü Genomically engineered microbial communities üüü Biomining/bioleaching üüü Cell-free products ü Nucleic Acids Organisms/ Synthetic DNA barcodes to track products ü ü RNA-based spray for insect-pest control ü Genomically recoded organisms ü Biological/mechanical hybrid biosensors ü ü üüü = an area the committee has identified as having high growth potential. aThe table reflects the market status of products at the time the committee was writing the report.
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From page 48... ...
The committee anticipated that, in addition to crops, plants engineered for nonagricultural purposes would become more common and that many of these would be designed to persist in the environment under low and no management conditions. For example, a GE American chestnut contained an introduced enzyme, oxalate oxidase, which was extracted from wheat to confer resistance to a blight that has killed about 4 billion chestnut trees in North America since the early 1900s (Zhang et al., 2013)
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. Application of this technology to other invasive species 30Sterilizedpink bollworm with a genetically engineered fluorescent marker has been field tested in Arizona since 2006.
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. Such products were envisioned as future products of biotechnology in the 1986 Coordinated Framework for Regulation of Biotechnology.
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Microbial products that are genetically engineered are also under development for plant microbiomes. The clearest example is the manipulation of nitrogen fixation in heterologous prokaryotes (Smanski et al., 2014)
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Because performing biotechnology in contained environments allows higher control over the choice of host organism, systems with advanced molecular toolboxes are already in high use. As above, possible future biotechnology products captured in Figure 2-8 and Table 2-4 are organized around their time to market (horizontal axis)
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Arrows indicate that the committee anticipated that similar products or products using the same transformation technology (for example genome editing or gene drives) are likely to be developed.
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Polymers produced by plants for industrial use ü Greenhouse crops with CRISPR knockouts ü Industrial enzymes ü ü ü Biobased chemicals to replace fossil fuel ü ü ü feedstocks Microbes and Microbial Products Bioluminescent microbes for home and landscape ü ü uses Yeast-derived molecules to create products (e.g., ü üüü üüü vanillin, stevia, saffron, egg whites, milk protein, gelatin) Synthetic silk ü Bacterium-derived antimicrobials ü Genomically engineered bacterial strains for üüü fermentation-based products Gas-phase microbial systems ü Algae-derived products (e.g., substitute for shark üüü üüü fins and shrimp, biofuels, ethylene)
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From page 55... ...
The regulators have long seen such products, with the classic example being insulin for medical purposes. A more recent, synthetic biology example is being deployed against traditional gas-phase fermentation organisms (already in use at pilot or demonstration scale for ethanol production from CO or CO2)
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Engineered microbes: bacteria, yeast, algae Gen9a Gene synthesis Ginkgo Bioworks Engineered microorganisms Greenlight Biosciences Cell-free bioprocessing technology Molecular Assemblies DNA synthesis Muse Biotechnologies, Inc. Strain engineering Oligos Biotech Engineered fungus Pareto Biotechnologies Polyketide pathways Syngulon Bacteriocin engineering Synpromics Synthetic promotors for gene expression Synthetic Genomics Advanced genomic engineering: microbial cell lines, DHA Omega-3, Astaxanthin Teselagen Combinatorial gene design and editing Twist Bioscience Gene synthesis on silicon Zymergen Strain improvement aIn January 2017, Ginkgo Bioworks acquired Gen9.
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SUMMARY AND CONCLUSIONS This chapter describes some of the technological, economic, and social trends that will likely drive the development of future products of biotechnology; outlines the changes in the scope, scale, complexity, and tempo of biotechnology products; and provides a detailed account of new products that are likely to emerge in the next 5–10 years. The committee reached the following broad conclusions regarding emerging trends and products of biotechnology.
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From page 58... ...
Conclusion 2-4: Some future products of biotechnology may be wholly unlike products that existed in 2016. The increased capabilities to transform genomes afforded by advances in genomic engineering allow product developers to expand the number and kinds of modifications in future biotechnology products.
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Presentation to the National Academies of Sciences, Engineer ing, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 1, Washington, DC. Cummings, C., and J
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TAXA. Presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 27, San Francisco, CA.
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Presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 1, Washington, DC. Kwong, W.K., and N.A.
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Presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 1, Washington, DC. Nagare, P., B.A.
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Presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 1, Washington, DC. Regalado, A
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Presentation to the National Academies of Sciences, Engineering, and Medicine Com mittee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, June 1, Washington, DC.
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Plant Biotechnology Journal 15(5)
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