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Thursday, November 25, 2021

Biobased economy

From Wikipedia, the free encyclopedia

Biobased economy, bioeconomy or biotechonomy refers to economic activity involving the use of biotechnology and biomass in the production of goods, services, or energy. The terms are widely used by regional development agencies, national and international organizations, and biotechnology companies. They are closely linked to the evolution of the biotechnology industry and the capacity to study, understand, and manipulate genetic material that has been possible due to scientific research and technological development. This includes the application of scientific and technological developments to agriculture, health, chemical, and energy industries.

A video by New Harvest / Xprize explaining the development of cultured meat and a "post-animal bio-economy, driven by lab grown protein (meat, eggs, milk)". (Runtime 3:09)

The terms bioeconomy (BE) and bio-based economy (BBE) are sometimes used interchangeably. However, it is worth to distinguish them: the biobased economy takes into consideration the production of non-food goods, whilst bioeconomy covers both bio-based economy and the production and use of food and feed.

Origins and definitions

Bioeconomy has large variety of definitions. The bioeconomy comprises those parts of the economy that use renewable biological resources from land and sea – such as crops, forests, fish, animals and micro-organisms – to produce food, health, materials, products, textiles and energy.

In 2010 it was defined in the report “The Knowledge Based Bio-Economy (KBBE) in Europe: Achievements and Challenges” by Albrecht & al. as follows: The bio-economy is the sustainable production and conversion of biomass, for a range of food, health, fibre and industrial products and energy, where renewable biomass encompasses any biological material to be used as raw material.”

The First Global Bioeconomy Summit in Berlin in November 2015 defines bioeconomy as “knowledge-based production and utilization of biological resources, biological processes and principles to sustainably provide goods and services across all economic sectors”. According to the summit, bioeconomy involves three elements: renewable biomass, enabling and converging technologies, and integration across applications concerning primary production (i.e. all living natural resources), health (i.e. pharmaceuticals and medical devices), and industry (i.e. chemicals, plastics, enzymes, pulp and paper, bioenergy).

The term 'biotechonomy' was used by Juan Enríquez and Rodrigo Martinez at the Genomics Seminar in the 1997 AAAS meeting. An excerpt of this paper was published in Science."

An important aspect of the bioeconomy is understanding mechanisms and processes at the genetic, molecular, and genomic levels, and applying this understanding to creating or improving industrial processes, developing new products and services, and producing new energy. Bioeconomy aims to reduce our dependence on fossil natural resources, to prevent biodiversity loss and to create new economic growth and jobs that are in line with the principles of sustainable development.

History

Enríquez and Martinez' 2002 Harvard Business School working paper, "Biotechonomy 1.0: A Rough Map of Biodata Flow", showed the global flow of genetic material into and out of the three largest public genetic databases: GenBank, EMBL and DDBJ. The authors then hypothesized about the economic impact that such data flows might have on patent creation, evolution of biotech startups and licensing fees. An adaptation of this paper was published in Wired magazine in 2003.

The term 'bioeconomy' became popular from the mid-2000s with its adoption by the European Union and Organisation for Economic Co-operation and Development as a policy agenda and framework to promote the use of biotechnology to develop new products, markets, and uses of biomass. Since then, both the EU (2012) and OECD (2006) have created dedicated bioeconomy strategies, as have an increasing number of countries around the world. Often these strategies conflate the bioeconomy with the term 'bio-based economy'. For example, since 2005 the Netherlands has sought to promote the creation of a biobased economy. Pilot plants have been started i.e. in Lelystad (Zeafuels), and a centralised organisation exists (Interdepartementaal programma biobased economy), with supporting research (Food & Biobased Research) being conducted. Other European countries have also developed and implemented bioeconomy or bio-based economy policy strategies and frameworks.

In 2012 president Barack Obama of the USA announced intentions to encourage biological manufacturing methods, with a National Bioeconomy Blueprint.

Aims

Global population growth and over consumption of many resources are causing increasing environmental pressure and climate change. Bioeconomy tackles with these challenges. It aims to ensure food security and to promote more sustainable natural resource use as well as to reduce the dependence on non-renewable resources, e.g. fossil natural resources and minerals. In some extent bioeconomy also helps economy to reduces greenhouse gas emissions and assists in mitigating and adapting to climate change.

Genetic modification

Organisms, ranging from bacteria over yeasts up to plants are used for production of enzymatic catalysis. Genetically modified bacteria have been used to produce insulin, artemisinic acid was made in engineered yeast. Some bioplastics (based on polyhydroxylbutyrate or polyhydroxylalkanoates are produced from sugar using genetically modified microbes.

Genetically modified organisms are also used for the production of biofuels. Biofuels are a type of Carbon-neutral fuel.

Research is also being done towards CO2 fixation using a synthetic metabolic pathway. By genetically modifying E. coli bacteria so as to allow them to consume CO2, the bacterium may provide the infrastructure for the future renewable production of food and green fuels.

One of the organisms (Ideonella sakaiensis) that is able to break down PET (a plastic) into other substances has been genetically modified to break down PET even faster and also break down PEF. Once plastics (which are normally non-biodegradable) are broken down and recycled into other substances (i.e. biomatter in the case of Tenebrio molitor larvae) it can be used as an input for other animals.

Genetically modified crops are also used. Genetically modified energy crops for instance may provide some additional advantages such as reduced associated costs (i.e. costs during the manufacturing process ) and less water use. One example are trees have been genetically modified to either have less lignin, or to express lignin with chemically labile bonds.

With genetically modified crops however, there are still some challenges involved (hurdles to regulatory approvals, market adoption and public acceptance).

Fields

According to European Union Bioeconomy Strategy updated in 2018 the bioeconomy covers all sectors and systems that rely on biological resources (animals, plants, micro-organisms and derived biomass, including organic waste), their functions and principles. It covers all primary production and economic and industrial sectors that base on use, production or processing biological resources from agriculture, forestry, fisheries and aquaculture. The product of bioeconomy are typically food, feed and other biobased products, bioenergy and services based on biological resources. The bioeconomy aims to drive towards sustainability, circularity as well as the protection of the environment and will enhance biodiversity.

In some definitions, bioeconomy comprises also ecosystem services that are services offered by the environment, including binding carbon dioxide and opportunities for recreation. Another key aspect of the bioeconomy is not wasting natural resources but using and recycling them efficiently.

According to EU Bioeconomy Report 2016, the bioeconomy brings together various sectors of the economy that produce, process and reuse renewable biological resources (agriculture, forestry, fisheries, food, bio-based chemicals and materials and bioenergy).

Agriculture

Cellular agriculture focuses on the production of agriculture products from cell cultures using a combination of biotechnology, tissue engineering, molecular biology, and synthetic biology to create and design new methods of producing proteins, fats, and tissues that would otherwise come from traditional agriculture. Most of the industry is focused on animal products such as meat, milk, and eggs, produced in cell culture rather than raising and slaughtering farmed livestock which is associated with substantial global problems of detrimental environmental impacts (e.g. of meat production), animal welfare, food security and human health. Cellular agriculture is field of the biobased economy. The most well known cellular agriculture concept is cultured meat.

However, not all synthetic nutrition products are animal food products – for instance, as of 2021 there are also products of synthetic coffee that are reported to be close to commercialization. Similar fields of research and production based on bioeconomy agriculture are:

Many of the foods produced with tools and methods of the bioeconomy may not be intended for human consumption but for non-human animals such as for livestock feed, insect-based pet food or sustainable aquacultural feed.

Moreover, crops could be genetically engineered in ways that e.g. safely increase yields, reduce the need for pesticides or ease indoor production.

One example of a product highly specific to the bioeconomy that is widely available is algae oil which is a dietary supplement that could substitute fish oil supplements.

Waste management, recycling and biomining

Biobased applications, research and development of waste management may form a part of the bioeconomy. Bio-based recycling (e-waste, plastics recycling, etc.) is linked to waste management and relevant standards and requirements of production and products. Some of the recycling of waste may be biomining and some biomining could be applied beyond recycling.

For example, in 2020, biotechnologists reported the genetically engineered refinement and mechanical description of synergistic enzymes – PETase, first discovered in 2016, and MHETase of Ideonella sakaiensis – for faster depolymerization of PET and also of PEF, which may be useful for depollution, recycling and upcycling of mixed plastics along with other approaches. Such approaches may be more environment-friendly as well as cost-effective than mechanical and chemical PET-recycling, enabling circular plastic bio-economy solutions via systems based on engineered strains. Moreover, microorganisms could be employed to mine useful elements from basalt rocks via bioleaching.

Medicine, nutritional science and the health economy

In 2020, the global industry for dietary supplements was valued at $140.3 billion by a "Grand View Research" analysis. Certain parts of the health economy may overlap with the bioeconomy, including anti-aging- and life extension-related products and activities, hygiene/beauty products, functional food, sports performance related products and bio-based tests (such as of one's microbiota) and banks (such as stool banks and DNA databases), all of which can in turn be used for individualized interventions, monitoring as well as for the development of new products. The pharmaceutical sector, including the research and development of new antibiotics, can also be considered to be a bioeconomy sector.

Forest bioeconomy

The forest bioeconomy is based on forests and their natural resources, and covers a variety of different industry and production processes. Forest bioeconomy includes, for example, the processing of forest biomass to provide products relating to, energy, chemistry, or the food industry. Thus, forest bioeconomy covers a variety of different manufacturing processes that are based on wood material and the range of end products is wide.

Besides different wood-based products, recreation, nature tourism and game are a crucial part of forest bioeconomy. Carbon sequestration and ecosystem services are also included to the concept of forest bioeconomy.

Pulp, paper, packaging materials and sawn timber are the traditional products of the forest industry. Wood is also traditionally used in furniture and construction industries. But in addition to these, as a renewable natural resource, ingredients from wood can be valorised into innovative bioproducts, alongside a range of conventional forest industry products. Thus, traditional mill sites of large forest industry companies, for example in Finland, are in the process of becoming biorefineries. In different processes, forest biomass is used to produce for example, textiles, chemicals, cosmetics, fuels, medicine, intelligent packaging, coatings, glues, plastics, food and feed.

Blue bioeconomy

The blue bioeconomy covers businesses that are based on the sustainable use of renewable aquatic resources as well water related expertise areas. It covers the development and marketing of blue bioeconomy products and services. In that respect, the key sectors include business activities based on water expertise and technology, water-based tourism, making use of aquatic biomass, and the value chain of fisheries. Furthermore, the immaterial value of aquatic natural resources is also very high. Water areas have also other values but the platform of economic activities. It provides human well-being, recreation and health.

According to the European Union the blue bioeconomy has the focus on aquatic or marine environments, especially, on novel aquaculture applications, including non-food, food and feed.

In the European Report on the Blue Growth Strategy - Towards more sustainable growth and jobs in the blue economy (2017) the blue bioeconomy is defined different than blue economy. The blue economy means the industries that are related to marine environment activities, e.g. shipbuilding, transport, coastal tourism, renewable energies, such as off-shore windmills, living and non-living resources.

Energy

The bioeconomy also covers bioenergy, biohydrogen, biofuel and algae fuel.

According to World Bioenergy Association 17,8 % out of gross final energy consumption was covered with renewables energy. Among renewable energy sources, bioenergy (energy from bio-based sources) is the largest renewable energy. In 2017, bioenergy accounted for 70% of the renewable energy consumption. (Global bioenergy statistics 2019)

The role of bioenergy varies in different countries and continents. In Africa it is the most important energy sources with the share of 96%. Bioenergy has significant shares in energy production in Americas (59%), Asia (65%) and Europe (59%). The bioenergy is produced out of a large variety of biomass from forestry, agriculture and waste and side streams of industries to produce useful end products (pellets, wood chips, bioethanol, biogas and biodiesel) ending up for electricity, heat and transportation fuel around the world.

Biomass is renewable nature resource but it is still limited resource. Globally there are huge resources, but it the environmental, social and economic aspect are limiting the use. Biomass, however, can play important role and source of products towards low-carbon solutions in the field of customer supplies, energy, food and feed. In practice, there are many competing uses.

The biobased economy uses first-generation biomass (crops), second-generation biomass (crop refuge), and third-generation biomass (seaweed, algae). Several methods of processing are then used (in biorefineries) to gather the most out of the biomass. This includes techniques such as

Anaerobic digestion is generally used to produce biogas, fermentation of sugars produces ethanol, pyrolysis is used to produce pyrolysis-oil (which is solidified biogas), and torrefaction is used to create biomass-coal. Biomass-coal and biogas is then burnt for energy production, ethanol can be used as a (vehicle)-fuel, as well as for other purposes, such as skincare products.

Getting the most out of the biomass

For economic reasons, the processing of the biomass is done according to a specific pattern (a process called cascading). This pattern depends on the types of biomass used. The whole of finding the most suitable pattern is known as biorefining. A general list shows the products with high added value and lowest volume of biomass to the products with the lowest added value and highest volume of biomass:

  • fine chemicals/medicines
  • food
  • chemicals/bioplastics
  • transport fuels
  • electricity and heat

Other fields and applications

Bioproducts or bio-based products are products that are made from biomass. The term “bioproduct” refers to a wide array of industrial and commercial products that are characterized by a variety of properties, compositions and processes, as well as different benefits and risks.

Bio-based products are developed in order to reduce dependency on fossil fuels and non-renewable resources. To achieve this, the key is to develop new bio-refining technologies to sustainably transform renewable natural resources into bio-based products, materials and fuels, e.g.

Nanoparticles, artificial cells and micro-droplets

Synthetic biology can be used for creating nanoparticles which can be used for drug-delivery as well as for other purposes. Complementing research and development seeks to and has created synthetic cells that mimics functions of biological cells. Applications include medicine such as designer-nanoparticles that make blood cells eat away – from the inside out – portions of atherosclerotic plaque that cause heart attacks. Synthetic micro-droplets for algal cells or synergistic algal-bacterial multicellular spheroid microbial reactors, for example, could be used to produce hydrogen as hydrogen economy biotechnology.

Climate change adaptation

Activities and technologies for bio-based climate change adaptation could be considered as part of the bioeconomy and may include artificial assistance to make coral reefs more resilient against climate change such as via application of probiotics.

Materials

There is a potential for biobased-production of building materials (insulation, surface materials, etc.) as well as new materials in general (polymers, plastics, composites, etc.). Photosynthetic microbial cells have been used as a step to synthetic production of spider silk.

Bioplastics

Bioplastics are not just one single material. They comprise a whole family of materials with different properties and applications. According to European Bioplastics, a plastic material is defined as a bioplastic if it is either bio-based plastic, biodegradable plastic, or is a material with both properties. Bioplastics have the same properties as conventional plastics and offer additional advantages, such as a reduced carbon footprint or additional waste management options, such as composting.

Bioplastics are divided into three main groups:

  • Bio-based or partially bio-based non-biodegradable plastics such as bio-based PE, PP, or PET (so-called drop-ins) and bio-based technical performance polymers such as PTT or TPC-ET
  • Plastics that are both bio-based and biodegradable, such as PLA and PHA or PBS
  • Plastics that are based on fossil resources and are biodegradable, such as PBAT

Additionally, new materials such as PLA, PHA, cellulose or starch-based materials offer solutions with completely new functionalities such as biodegradability and compostability, and in some cases optimized barrier properties. Along with the growth in variety of bioplastic materials, properties such as flexibility, durability, printability, transparency, barrier, heat resistance, gloss and many more have been significantly enhanced.

Bioplastics have been made from sugarbeet, by bacteria.

Examples of bioplastics
  • Paptic: There are packaging materials which combine the qualities of paper and plastic. For example, Paptic is produced from wood-based fibre that contains more than 70% wood. The material is formed with foam-forming technology that saves raw material and improves the qualities of the material. The material can be produced as reels, which enables it to be delivered with existing mills. The material is spatter-proof but is decomposed when put under water. It is more durable than paper and maintains its shape better than plastic. The material is recycled with cardboards.
Examples of bio-composites
  • Sulapac tins are made from wood chips and biodegradable natural binder and they have features similar to plastic. These packaging products tolerate water and fats, and they do not allow oxygen to pass. Sulapac products combine ecology, luxury and are not subject to design limitations. Sulapac can compete with traditional plastic tins by cost and is suitable for the same packing devices.
  • Woodio produces wood composite sinks and other bathroom furniture. The composite is produced by moulding a mixture of wood chips and crystal clear binder. Woodio has developed a solid wood composite that is entirely waterproof. The material has similar features to ceramic, but can be used as energy after use. unlike ceramic waste. Solid wood composite is hard and can be moulded with wooden tools.
  • Woodcast is a renewable and biodegradable casting material. It is produced from woodchips and biodegradable plastic. It is hard and durable in room temperature but when heated is flexible and self-sticky. Woodcast can be applied to all plastering and supporting elements. The material is breathable and X-ray transparent. It is used in plastering and in occupational therapy and can be moulded to any anatomical shape. Excess pieces can be reused: used casts can be disposed of either as energy or biowaste. The composite differs from traditional lime cast in that it doesn’t need water and it is non-toxic. Therefore gas-masks, gauntlets or suction fans are not required when handling the cast.
For sustainable packaging

Plastic packages or plastic components are sometimes part of a valid environmental solution. Other times, alternatives to plastic are desiredable.

Materials have been developed or used for packaging without plastics, especially for use-cases in which packaging can't be phased-out – such as with policies for national grocery store requirements – for being needed for preserving food products or other purposes.

Optical appearance of self-assembled films of sustainable packaging alternative to plastic.webp

A plant proteins-based biodegradable packaging alternative to plastic was developed based on research about spider silk which is known for its high strength and similar on the molecular level.

Researchers at the Agricultural Research Service are looking into using dairy-based films as an alternative to petroleum-based packaging.  Instead of being made of synthetic polymers, these dairy-based films would be composed of proteins such as casein and whey, which are found in milk. The films would be biodegradable and offer better oxygen barriers than synthetic, chemical-based films. More research must be done to improve the water barrier quality of the dairy-based film, but advances in sustainable packaging are actively being pursued.

Sustainable packaging policy cannot be individualized by a specific product. Effective legislation would need to include alternatives to many products, not just a select few; otherwise, the positive impacts of sustainable packing will not be as effective as they need in order to propel a significant reduction of plastic packaging. Finding alternatives can reduce greenhouse gas emissions from unsustainable packaging production and reduce dangerous chemical by-products of unsustainable packaging practices.

Bio-Based Plastics

Another alternative to commonly used petroleum plastics are bio-based plastics. Examples of bio-based plastics include natural biopolymers and polymers synthesized from natural feedstock monomers, which can be extracted from plants, animals, or microorganisms. A polymer that is bio-based and used to make plastic materials is not necessarily compostable or bio-degradable. Natural biopolymers can be often biodegraded in the natural environment while only a few bio-based monomer bio-based plastics can be. Bio-based plastics are a more sustainable option in comparison to their petroleum based counterparts, yet they only account for 1% of plastics produced annually as of 2020.

Chitosan

Chitosan is a studied biopolymer that can be used as a packaging alternative that increases shelf life and reduces the use of synthetic plastics. Chitosan is a polysaccharide that is obtained through the deacetylation of chitin, the second most abundant polysaccharide on Earth derived from the non-edible portions of marine invertebrates. The increased use of chitosan has the possibility to reduce food waste and the waste from food packaging. Chitosan is compiled of antimicrobial activities and film forming properties which make it biodegradable and deter growth of spoilage. In comparison to degrading synthetic plastics, that may take years, biopolymers such as chitosan can degrade in weeks. Antimicrobial packaging includes techniques such as modified atmospheric packaging that reduce activities of microbes and bacterial growth. Chitosan as an alternative promotes less food waste and less reliance on non-degradable plastic materials.

Textiles

The textile industry, or certain activities and elements of it, could be considered to be a strong global bioeconomy sector. Textiles are produced from natural fibres, regenerated fibres and synthetic fibres (Sinclair 2014). The natural fibre textile industry is based on cotton, linen, bamboo, hemp, wool, silk, angora, mohair and cashmere.

Activities related to textile production and processing that more clearly fall under the domain of the bioeconomy are developments such as the biofabrication of leather-like material using fungi.

Textile fibres can be formed in chemical processes from bio-based materials. These fibres are called bio-based regenerated fibres. The oldest regenerated fibres are viscose and rayon, produced in the 19th century. The first industrial processes used a large amount of wood as raw material, as well as harmful chemicals and water. Later the process of regenerating fibres developed to reduce the use of raw materials, chemicals, water and energy.

In the 1990s the first more sustainable regenerated fibres, e.g. Lyocell, entered the market with the commercial name of Tencel. The production process uses wood cellulose and it processes the fibre without harmful chemicals.

The next generation of regenerated fibres are under development. The production processes use less or no chemicals, and the water consumption is also diminished.

Issues

Degrowth, green growth and circular economy

The bioeconomy has largely been associated with visions of "green growth". A study found that a "circular bioeconomy" may be "necessary to build a carbon neutral future in line with the climate objectives of the Paris Agreement". However, some are concerned that with a focus or reliance on technological progress a fundamentally unsustainable socioeconomic model might be maintained rather than be changed. Some are concerned it that may not lead to a ecologization of the economy but to an economization of the biological, "the living" and caution that potentials of non-bio-based techniques to achieve greater sustainability need to be considered. A study found that the, as of 2019, current EU interpretation of the bioeconomy is "diametrically opposite to the original narrative of Baranoff and Georgescu-Roegen that told us that expanding the share of activities based on renewable resources in the economy would slow down economic growth and set strict limits on the overall expansion of the economy". Furthermore, some caution that "Silicon Valley and food corporations" could use bioeconomy technologies for greenwashing and monopoly-concentrations. The bioeconomy, its potentials, disruptive new modes of production and innovations may distract from the need for systemic structural socioeconomic changes and provide a false illusion of technocapitalist utopianism/optimism that suggests technological fixes may make it possible to sustain contemporary patterns and structures.

Unemployment and work reallocation

Many farmers depend on conventional methods of producing crops and many of them live in developing economies. Cellular agriculture for products such as synthetic coffee could, if the contemporary socioeconomic context (the socioeconomic system's mechanisms such as incentives and resource distribution mechanisms like markets) remains unaltered (e.g. in nature, purposes, scopes, limits and degrees), threaten their employment and livelihoods as well as the respective nation's economy and social stability. A study concluded that "given the expertise required and the high investment costs of the innovation, it seems unlikely that cultured meat immediately benefits the poor in developing countries" and emphasized that animal agriculture is often essential for the subsistence for farmers in poor countries. However, not only developing countries may be affected.

Patents, intellectual property and monopolies

Some observers worry that the bioeconomy will become as opaque and accountability-free as the industry it aims to replace (e.g. the current food system). Its core products may be mass-produced, nutritionally dubious meat sold at homogeneous fast-food joints.

The medical community has warned that gene patents can inhibit the practice of medicine and progress of science. This can also apply to other areas where patents and private intellectual property licenses are being used, often entirely preventing the use and continued development of knowledge and techniques for many years or decades. On the other hand, some worry that without intellectual property protection as the type of R&D-incentive, particularly to current degrees and extents, companies would no longer have the resources or motives/incentives to perform competitive, viable biotech research – as otherwise they may not be able to generate sufficient returns from initial R&D investment or less returns than from other expenditures that are possible. "Biopiracy" refers to "the use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products that have been used over centuries in non-industrialized cultures".

Rather than leading to sustainable, healthy, inexpensive, safe, accessible food being produced with little labor locally – after knowledge- and technology transfer and timely, efficient innovation – the bioeconomy may lead to aggressive monopoly-formation and exacerbated inequality. For instance, while production costs may be minimal, costs – including of medicine – may be high.

Innovation management, public spending and governance

It has been argued that public investment would be a tool governments should use to regulate and license cellular agriculture. Private firms and venture capital would likely seek to maximise investor value rather than social welfare. Moreover, radical innovation is considered to be more risky, "and likely involves more information asymmetry, so that private financial markets may imperfectly manage these frictions". Governments may also help to coordinate "since several innovators may be needed to push the knowledge frontier and make the market profitable, but no single company wants to make the early necessary investments". They could also help innovators that lack the network "to naturally obtain the visibility and political influence necessary to obtain public funds" and could help determine relevant laws.

In popular media

Biopunk is a genre of science fiction, so called due to similarity with cyberpunk, that often thematizes the bioeconomy as well as its issues and technologies. The novel The Windup Girl portrays a world of society driven by a ruthless bioeconomy and ailing under climate change. In the more recent novel Change Agent prevalent black market clinics offer wealthy people unauthorized genetic human enhancement services and custom narcotics are 3D-printed locally or smuggled with soft robots. Solarpunk is another emerging genre that focuses on the relationship between human societies and the environment and also adresses many of the bioeconomy's issues and technologies such as genetic engineering, synthetic meat and commodification.

Synthetic biology

From Wikipedia, the free encyclopedia
 
Synthetic Biology Research at NASA Ames Research Center.

Synthetic biology (SynBio) is a multidisciplinary area of research that seeks to create new biological parts, devices, and systems, or to redesign systems that are already found in nature.

It is a branch of science that encompasses a broad range of methodologies from various disciplines, such as biotechnology, genetic engineering, molecular biology, molecular engineering, systems biology, membrane science, biophysics, chemical and biological engineering, electrical and computer engineering, control engineering and evolutionary biology.

Due to more powerful genetic engineering capabilities and decreased DNA synthesis and sequencing costs, the field of synthetic biology is rapidly growing. In 2016, more than 350 companies across 40 countries were actively engaged in synthetic biology applications; all these companies had an estimated net worth of $3.9 billion in the global market.

Definition

Synthetic biology currently has no generally accepted definition. Here are a few examples:

  • "the use of a mixture of physical engineering and genetic engineering to create new (and, therefore, synthetic) life forms"
  • "an emerging field of research that aims to combine the knowledge and methods of biology, engineering and related disciplines in the design of chemically synthesized DNA to create organisms with novel or enhanced characteristics and traits"
  • "designing and constructing biological modules, biological systems, and biological machines or, re-design of existing biological systems for useful purposes"
  • “applying the engineering paradigm of systems design to biological systems in order to produce predictable and robust systems with novel functionalities that do not exist in nature” (The European Commission, 2005) This can include the possibility of a molecular assembler, based upon biomolecular systems such as the ribosome

Synthetic biology has traditionally been divided into two different approaches: top down and bottom up.

  1. The top down approach involves using metabolic and genetic engineering techniques to impart new functions to living cells.
  2. The bottom up approach involves creating new biological systems in vitro by bringing together 'non-living' biomolecular components, often with the aim of constructing an artificial cell.

Biological systems are thus assembled module-by-module. Cell-free protein expression systems are often employed, as are membrane-based molecular machinery. There are increasing efforts to bridge the divide between these approaches by forming hybrid living/synthetic cells, and engineering communication between living and synthetic cell populations.

History

1910: First identifiable use of the term "synthetic biology" in Stéphane Leduc's publication Théorie physico-chimique de la vie et générations spontanées. He also noted this term in another publication, La Biologie Synthétique in 1912.

1961: Jacob and Monod postulate cellular regulation by molecular networks from their study of the lac operon in E. coli and envisioned the ability to assemble new systems from molecular components.

1973: First molecular cloning and amplification of DNA in a plasmid is published in P.N.A.S. by Cohen, Boyer et al. constituting the dawn of synthetic biology.

1978: Arber, Nathans and Smith win the Nobel Prize in Physiology or Medicine for the discovery of restriction enzymes, leading Szybalski to offer an editorial comment in the journal Gene:

The work on restriction nucleases not only permits us easily to construct recombinant DNA molecules and to analyze individual genes, but also has led us into the new era of synthetic biology where not only existing genes are described and analyzed but also new gene arrangements can be constructed and evaluated.

1988: First DNA amplification by the polymerase chain reaction (PCR) using a thermostable DNA polymerase is published in Science by Mullis et al. This obviated adding new DNA polymerase after each PCR cycle, thus greatly simplifying DNA mutagenesis and assembly.

2000: Two papers in Nature report synthetic biological circuits, a genetic toggle switch and a biological clock, by combining genes within E. coli cells.

2003: The most widely used standardized DNA parts, BioBrick plasmids, are invented by Tom Knight. These parts will become central to the international Genetically Engineered Machine competition (iGEM) founded at MIT in the following year.

Synthetic Biology Open Language (SBOL) standard visual symbols for use with BioBricks Standard

2003: Researchers engineer an artemisinin precursor pathway in E. coli.

2004: First international conference for synthetic biology, Synthetic Biology 1.0 (SB1.0) is held at the Massachusetts Institute of Technology, USA.

2005: Researchers develop a light-sensing circuit in E. coli. Another group designs circuits capable of multicellular pattern formation.

2006: Researchers engineer a synthetic circuit that promotes bacterial invasion of tumour cells.

2010: Researchers publish in Science the first synthetic bacterial genome, called M. mycoides JCVI-syn1.0. The genome is made from chemically-synthesized DNA using yeast recombination.

2011: Functional synthetic chromosome arms are engineered in yeast.

2012: Charpentier and Doudna labs publish in Science the programming of CRISPR-Cas9 bacterial immunity for targeting DNA cleavage. This technology greatly simplified and expanded eukaryotic gene editing.

2019: Scientists at ETH Zurich report the creation of the first bacterial genome, named Caulobacter ethensis-2.0, made entirely by a computer, although a related viable form of C. ethensis-2.0 does not yet exist.

2019: Researchers report the production of a new synthetic (possibly artificial) form of viable life, a variant of the bacteria Escherichia coli, by reducing the natural number of 64 codons in the bacterial genome to 59 codons instead, in order to encode 20 amino acids.

Perspectives

Engineers view biology as a technology (in other words, a given system includes biotechnology or its biological engineering) Synthetic biology includes the broad redefinition and expansion of biotechnology, with the ultimate goals of being able to design and build engineered live biological systems that process information, manipulate chemicals, fabricate materials and structures, produce energy, provide food, and maintain and enhance human health, as well as advance fundamental knowledge of biological systems (see Biomedical Engineering) and our environment.

Studies in synthetic biology can be subdivided into broad classifications according to the approach they take to the problem at hand: standardization of biological parts, biomolecular engineering, genome engineering, metabolic engineering.

Biomolecular engineering includes approaches that aim to create a toolkit of functional units that can be introduced to present new technological functions in living cells. Genetic engineering includes approaches to construct synthetic chromosomes or minimal organisms like Mycoplasma laboratorium.

Biomolecular design refers to the general idea of de novo design and additive combination of biomolecular components. Each of these approaches share a similar task: to develop a more synthetic entity at a higher level of complexity by inventively manipulating a simpler part at the preceding level.

On the other hand, "re-writers" are synthetic biologists interested in testing the irreducibility of biological systems. Due to the complexity of natural biological systems, it would be simpler to rebuild the natural systems of interest from the ground up; In order to provide engineered surrogates that are easier to comprehend, control and manipulate. Re-writers draw inspiration from refactoring, a process sometimes used to improve computer software.

Enabling technologies

Several novel enabling technologies were critical to the success of synthetic biology. Concepts include standardization of biological parts and hierarchical abstraction to permit using those parts in synthetic systems. Basic technologies include reading and writing DNA (sequencing and fabrication). Measurements under multiple conditions are needed for accurate modeling and computer-aided design (CAD).

DNA and gene synthesis

Driven by dramatic decreases in costs of oligonucleotide ("oligos") synthesis and the advent of PCR, the sizes of DNA constructions from oligos have increased to the genomic level. In 2000, researchers reported synthesis of the 9.6 kbp (kilo bp) Hepatitis C virus genome from chemically synthesized 60 to 80-mers. In 2002 researchers at Stony Brook University succeeded in synthesizing the 7741 bp poliovirus genome from its published sequence, producing the second synthetic genome, spanning two years. In 2003 the 5386 bp genome of the bacteriophage Phi X 174 was assembled in about two weeks. In 2006, the same team, at the J. Craig Venter Institute, constructed and patented a synthetic genome of a novel minimal bacterium, Mycoplasma laboratorium and were working on getting it functioning in a living cell.

In 2007 it was reported that several companies were offering synthesis of genetic sequences up to 2000 base pairs (bp) long, for a price of about $1 per bp and a turnaround time of less than two weeks. Oligonucleotides harvested from a photolithographic- or inkjet-manufactured DNA chip combined with PCR and DNA mismatch error-correction allows inexpensive large-scale changes of codons in genetic systems to improve gene expression or incorporate novel amino-acids (see George M. Church's and Anthony Forster's synthetic cell projects.) This favors a synthesis-from-scratch approach.

Additionally, the CRISPR/Cas system has emerged as a promising technique for gene editing. It was described as "the most important innovation in the synthetic biology space in nearly 30 years". While other methods take months or years to edit gene sequences, CRISPR speeds that time up to weeks. Due to its ease of use and accessibility, however, it has raised ethical concerns, especially surrounding its use in biohacking.

Sequencing

DNA sequencing determines the order of nucleotide bases in a DNA molecule. Synthetic biologists use DNA sequencing in their work in several ways. First, large-scale genome sequencing efforts continue to provide information on naturally occurring organisms. This information provides a rich substrate from which synthetic biologists can construct parts and devices. Second, sequencing can verify that the fabricated system is as intended. Third, fast, cheap, and reliable sequencing can facilitate rapid detection and identification of synthetic systems and organisms.

Modularity

The most used standardized DNA parts are BioBrick plasmids, invented by Tom Knight in 2003. Biobricks are stored at the Registry of Standard Biological Parts in Cambridge, Massachusetts. The BioBrick standard has been used by thousands of students worldwide in the international Genetically Engineered Machine (iGEM) competition.

Sequence overlap between two genetic elements (genes or coding sequences), called overlapping genes, can prevent their individual manipulation. To increase genome modularity, the practice of genome refactoring or improving "the internal structure of an existing system for future use, while simultaneously maintaining external system function" has been adopted across synthetic biology disciplines. Some notable examples of refactoring including the nitrogen fixation cluster and type III secretion system along with bacteriophages T7 and ΦX174.

While DNA is most important for information storage, a large fraction of the cell's activities are carried out by proteins. Tools can send proteins to specific regions of the cell and to link different proteins together. The interaction strength between protein partners should be tunable between a lifetime of seconds (desirable for dynamic signaling events) up to an irreversible interaction (desirable for device stability or resilient to harsh conditions). Interactions such as coiled coils, SH3 domain-peptide binding or SpyTag/SpyCatcher offer such control. In addition it is necessary to regulate protein-protein interactions in cells, such as with light (using light-oxygen-voltage-sensing domains) or cell-permeable small molecules by chemically induced dimerization.

In a living cell, molecular motifs are embedded in a bigger network with upstream and downstream components. These components may alter the signaling capability of the modeling module. In the case of ultrasensitive modules, the sensitivity contribution of a module can differ from the sensitivity that the module sustains in isolation.

Modeling

Models inform the design of engineered biological systems by better predicting system behavior prior to fabrication. Synthetic biology benefits from better models of how biological molecules bind substrates and catalyze reactions, how DNA encodes the information needed to specify the cell and how multi-component integrated systems behave. Multiscale models of gene regulatory networks focus on synthetic biology applications. Simulations can model all biomolecular interactions in transcription, translation, regulation and induction of gene regulatory networks.

Microfluidics

Microfluidics, in particular droplet microfluidics, is an emerging tool used to construct new components, and to analyse and characterize them. It is widely employed in screening assays.

Synthetic transcription factors

Studies have considered the components of the DNA transcription mechanism. One desire of scientists creating synthetic biological circuits is to be able to control the transcription of synthetic DNA in unicellular organisms (prokaryotes) and in multicellular organisms (eukaryotes). One study tested the adjustability of synthetic transcription factors (sTFs) in areas of transcription output and cooperative ability among multiple transcription factor complexes. Researchers were able to mutate functional regions called zinc fingers, the DNA specific component of sTFs, to decrease their affinity for specific operator DNA sequence sites, and thus decrease the associated site-specific activity of the sTF (usually transcriptional regulation). They further used the zinc fingers as components of complex-forming sTFs, which are the eukaryotic translation mechanisms.

Applications

Biosensors

A biosensor refers to an engineered organism, usually a bacterium, that is capable of reporting some ambient phenomenon such as the presence of heavy metals or toxins. One such system is the Lux operon of Aliivibrio fischeri, which codes for the enzyme that is the source of bacterial bioluminescence, and can be placed after a respondent promoter to express the luminescence genes in response to a specific environmental stimulus. One such sensor created, consisted of a bioluminescent bacterial coating on a photosensitive computer chip to detect certain petroleum pollutants. When the bacteria sense the pollutant, they luminesce. Another example of a similar mechanism is the detection of landmines by an engineered E.coli reporter strain capable of detecting TNT and its main degradation product DNT, and consequently producing a green fluorescent protein (GFP).

Modified organisms can sense environmental signals and send output signals that can be detected and serve diagnostic purposes. Microbe cohorts have been used.

Biosensors could also be used to detect pathogenic signatures – such as of SARS-CoV-2 – and can be wearable.

Food and drink

In 2021, researchers presented a bioprinting method to produce steak-like cultured meat.

Cellular agriculture focuses on the production of agriculture products from cell cultures using a combination of biotechnology, tissue engineering, molecular biology, and synthetic biology to create and design new methods of producing proteins, fats, and tissues that would otherwise come from traditional agriculture. Most of the industry is focused on animal products such as meat, milk, and eggs, produced in cell culture rather than raising and slaughtering farmed livestock which is associated with substantial global problems of detrimental environmental impacts (e.g. of meat production), animal welfare, food security and human health. Cellular agriculture is field of the biobased economy. The most well known cellular agriculture concept is cultured meat.

However, not all synthetic nutrition products are animal food products – for instance, as of 2021 there are also products of synthetic coffee that are reported to be close to commercialization. Similar fields of research and production based on synthetic biology that can be used for the production of food and drink are:

  • Genetically engineered microbial food cultures (e.g. for solar-energy-based protein powder);
  • Cell-free artificial synthesis (e.g. synthetic starch.

Materials

Photosynthetic microbial cells have been used as a step to synthetic production of spider silk.

Biological computers

A biological computer refers to an engineered biological system that can perform computer-like operations, which is a dominant paradigm in synthetic biology. Researchers built and characterized a variety of logic gates in a number of organisms, and demonstrated both analog and digital computation in living cells. They demonstrated that bacteria can be engineered to perform both analog and/or digital computation. In human cells research demonstrated a universal logic evaluator that operates in mammalian cells in 2007. Subsequently, researchers utilized this paradigm to demonstrate a proof-of-concept therapy that uses biological digital computation to detect and kill human cancer cells in 2011. Another group of researchers demonstrated in 2016 that principles of computer engineering, can be used to automate digital circuit design in bacterial cells. In 2017, researchers demonstrated the 'Boolean logic and arithmetic through DNA excision' (BLADE) system to engineer digital computation in human cells. In 2019, researchers implemented a perceptron in biological systems opening the way for machine learning in these systems.

Cell transformation

Cells use interacting genes and proteins, which are called gene circuits, to implement diverse function, such as responding to environmental signals, decision making and communication. Three key components are involved: DNA, RNA and Synthetic biologist designed gene circuits that can control gene expression from several levels including transcriptional, post-transcriptional and translational levels.

Traditional metabolic engineering has been bolstered by the introduction of combinations of foreign genes and optimization by directed evolution. This includes engineering E. coli and yeast for commercial production of a precursor of the antimalarial drug, Artemisinin.

Entire organisms have yet to be created from scratch, although living cells can be transformed with new DNA. Several ways allow constructing synthetic DNA components and even entire synthetic genomes, but once the desired genetic code is obtained, it is integrated into a living cell that is expected to manifest the desired new capabilities or phenotypes while growing and thriving. Cell transformation is used to create biological circuits, which can be manipulated to yield desired outputs.

By integrating synthetic biology with materials science, it would be possible to use cells as microscopic molecular foundries to produce materials with properties whose properties were genetically encoded. Re-engineering has produced Curli fibers, the amyloid component of extracellular material of biofilms, as a platform for programmable nanomaterial. These nanofibers were genetically constructed for specific functions, including adhesion to substrates, nanoparticle templating and protein immobilization.

Designed proteins

The Top7 protein was one of the first proteins designed for a fold that had never been seen before in nature

Natural proteins can be engineered, for example, by directed evolution, novel protein structures that match or improve on the functionality of existing proteins can be produced. One group generated a helix bundle that was capable of binding oxygen with similar properties as hemoglobin, yet did not bind carbon monoxide. A similar protein structure was generated to support a variety of oxidoreductase activities while another formed a structurally and sequentially novel ATPase. Another group generated a family of G-protein coupled receptors that could be activated by the inert small molecule clozapine N-oxide but insensitive to the native ligand, acetylcholine; these receptors are known as DREADDs. Novel functionalities or protein specificity can also be engineered using computational approaches. One study was able to use two different computational methods – a bioinformatics and molecular modeling method to mine sequence databases, and a computational enzyme design method to reprogram enzyme specificity. Both methods resulted in designed enzymes with greater than 100 fold specificity for production of longer chain alcohols from sugar.

Another common investigation is expansion of the natural set of 20 amino acids. Excluding stop codons, 61 codons have been identified, but only 20 amino acids are coded generally in all organisms. Certain codons are engineered to code for alternative amino acids including: nonstandard amino acids such as O-methyl tyrosine; or exogenous amino acids such as 4-fluorophenylalanine. Typically, these projects make use of re-coded nonsense suppressor tRNA-Aminoacyl tRNA synthetase pairs from other organisms, though in most cases substantial engineering is required.

Other researchers investigated protein structure and function by reducing the normal set of 20 amino acids. Limited protein sequence libraries are made by generating proteins where groups of amino acids may be replaced by a single amino acid. For instance, several non-polar amino acids within a protein can all be replaced with a single non-polar amino acid. One project demonstrated that an engineered version of Chorismate mutase still had catalytic activity when only 9 amino acids were used.

Researchers and companies practice synthetic biology to synthesize industrial enzymes with high activity, optimal yields and effectiveness. These synthesized enzymes aim to improve products such as detergents and lactose-free dairy products, as well as make them more cost effective. The improvements of metabolic engineering by synthetic biology is an example of a biotechnological technique utilized in industry to discover pharmaceuticals and fermentive chemicals. Synthetic biology may investigate modular pathway systems in biochemical production and increase yields of metabolic production. Artificial enzymatic activity and subsequent effects on metabolic reaction rates and yields may develop "efficient new strategies for improving cellular properties ... for industrially important biochemical production".

Designed nucleic acid systems

Scientists can encode digital information onto a single strand of synthetic DNA. In 2012, George M. Church encoded one of his books about synthetic biology in DNA. The 5.3 Mb of data was more than 1000 times greater than the previous largest amount of information to be stored in synthesized DNA. A similar project encoded the complete sonnets of William Shakespeare in DNA. More generally, algorithms such as NUPACK, ViennaRNA, Ribosome Binding Site Calculator, Cello, and Non-Repetitive Parts Calculator enables the design of new genetic systems.

Many technologies have been developed for incorporating unnatural nucleotides and amino acids into nucleic acids and proteins, both in vitro and in vivo. For example, in May 2014, researchers announced that they had successfully introduced two new artificial nucleotides into bacterial DNA. By including individual artificial nucleotides in the culture media, they were able to exchange the bacteria 24 times; they did not generate mRNA or proteins able to use the artificial nucleotides.

Space exploration

Synthetic biology raised NASA's interest as it could help to produce resources for astronauts from a restricted portfolio of compounds sent from Earth. On Mars, in particular, synthetic biology could lead to production processes based on local resources, making it a powerful tool in the development of manned outposts with less dependence on Earth. Work has gone into developing plant strains that are able to cope with the harsh Martian environment, using similar techniques to those employed to increase resilience to certain environmental factors in agricultural crops.

Synthetic life

Gene functions in the minimal genome of the synthetic organism, Syn 3.

One important topic in synthetic biology is synthetic life, that is concerned with hypothetical organisms created in vitro from biomolecules and/or chemical analogues thereof. Synthetic life experiments attempt to either probe the origins of life, study some of the properties of life, or more ambitiously to recreate life from non-living (abiotic) components. Synthetic life biology attempts to create living organisms capable of carrying out important functions, from manufacturing pharmaceuticals to detoxifying polluted land and water. In medicine, it offers prospects of using designer biological parts as a starting point for new classes of therapies and diagnostic tools.

A living "artificial cell" has been defined as a completely synthetic cell that can capture energy, maintain ion gradients, contain macromolecules as well as store information and have the ability to mutate. Nobody has been able to create such a cell.

A completely synthetic bacterial chromosome was produced in 2010 by Craig Venter, and his team introduced it to genomically emptied bacterial host cells. The host cells were able to grow and replicate. The Mycoplasma laboratorium is the only living organism with completely engineered genome.

The first living organism with 'artificial' expanded DNA code was presented in 2014; the team used E. coli that had its genome extracted and replaced with a chromosome with an expanded genetic code. The nucleosides added are d5SICS and dNaM.

In May 2019, researchers, in a milestone effort, reported the creation of a new synthetic (possibly artificial) form of viable life, a variant of the bacteria Escherichia coli, by reducing the natural number of 64 codons in the bacterial genome to 59 codons instead, in order to encode 20 amino acids.

In 2017 the international Build-a-Cell large-scale research collaboration for the construction of synthetic living cell was started, followed by national synthetic cell organizations in several countries, including FabriCell, MaxSynBio and BaSyC. The European synthetic cell efforts were unified in 2019 as SynCellEU initiative.

Drug delivery platforms

Engineered bacteria-based platform

Bacteria have long been used in cancer treatment. Bifidobacterium and Clostridium selectively colonize tumors and reduce their size. Recently synthetic biologists reprogrammed bacteria to sense and respond to a particular cancer state. Most often bacteria are used to deliver a therapeutic molecule directly to the tumor to minimize off-target effects. To target the tumor cells, peptides that can specifically recognize a tumor were expressed on the surfaces of bacteria. Peptides used include an affibody molecule that specifically targets human epidermal growth factor receptor 2 and a synthetic adhesin. The other way is to allow bacteria to sense the tumor microenvironment, for example hypoxia, by building an AND logic gate into bacteria. The bacteria then only release target therapeutic molecules to the tumor through either lysis or the bacterial secretion system. Lysis has the advantage that it can stimulate the immune system and control growth. Multiple types of secretion systems can be used and other strategies as well. The system is inducible by external signals. Inducers include chemicals, electromagnetic or light waves.

Multiple species and strains are applied in these therapeutics. Most commonly used bacteria are Salmonella typhimurium, Escherichia Coli, Bifidobacteria, Streptococcus, Lactobacillus, Listeria and Bacillus subtilis. Each of these species have their own property and are unique to cancer therapy in terms of tissue colonization, interaction with immune system and ease of application.

Cell-based platform

The immune system plays an important role in cancer and can be harnessed to attack cancer cells. Cell-based therapies focus on immunotherapies, mostly by engineering T cells.

T cell receptors were engineered and ‘trained’ to detect cancer epitopes. Chimeric antigen receptors (CARs) are composed of a fragment of an antibody fused to intracellular T cell signaling domains that can activate and trigger proliferation of the cell. A second generation CAR-based therapy was approved by FDA.

Gene switches were designed to enhance safety of the treatment. Kill switches were developed to terminate the therapy should the patient show severe side effects. Mechanisms can more finely control the system and stop and reactivate it. Since the number of T-cells are important for therapy persistence and severity, growth of T-cells is also controlled to dial the effectiveness and safety of therapeutics.

Although several mechanisms can improve safety and control, limitations include the difficulty of inducing large DNA circuits into the cells and risks associated with introducing foreign components, especially proteins, into cells.

Organoids

Synthetic biology has been used for organoids.

Bioprinted organs

There are several applications for 3D bioprinting in the medical field. An infant patient with a rare respiratory disease known as tracheobronchomalacia (TBM) was given a tracheal splint that was created with 3D printing. 3D bioprinting can be used to reconstruct tissue from various regions of the body. Patients with end-stage bladder disease can be treated by using engineered bladder tissues to rebuild the damaged organ. This technology can also potentially be applied to bone, skin, cartilage and muscle tissue. Though one long-term goal of 3D bioprinting technology is to reconstruct an entire organ, there has been little success in printing fully functional organs. Unlike implantable stents, organs have complex shapes and are significantly harder to bioprint. A bioprinted heart, for example, must not only meet structural requirements, but also vascularization, mechanical load, and electrical signal propagation requirements. Israeli researchers constructed a rabbit-sized heart out of human cells in 2019.

For bioprinted food like meat see #Food and drink.

Other transplants and induced regeneration

There is ongoing research and development into synthetic biology based methods for inducing regeneration in humans as well the creation of transplantable artificial organs.

Nanoparticles, artificial cells and micro-droplets

Synthetic biology can be used for creating nanoparticles which can be used for drug-delivery as well as for other purposes. Complementing research and development seeks to and has created synthetic cells that mimics functions of biological cells. Applications include medicine such as designer-nanoparticles that make blood cells eat away – from the inside out – portions of atherosclerotic plaque that cause heart attacks. Synthetic micro-droplets for algal cells or synergistic algal-bacterial multicellular spheroid microbial reactors, for example, could be used to produce hydrogen as hydrogen economy biotechnology.

Ethics

The creation of new life and the tampering of existing life has raised ethical concerns in the field of synthetic biology and are actively being discussed.

Common ethical questions include:

  • Is it morally right to tamper with nature?
  • Is one playing God when creating new life?
  • What happens if a synthetic organism accidentally escapes?
  • What if an individual misuses synthetic biology and creates a harmful entity (e.g., a biological weapon)?
  • Who will have control of and access to the products of synthetic biology?
  • Who will gain from these innovations? Investors? Medical patients? Industrial farmers?
  • Does the patent system allow patents on living organisms? What about parts of organisms, like HIV resistance genes in humans?
  • What if a new creation is deserving of moral or legal status?

The ethical aspects of synthetic biology has 3 main features: biosafety, biosecurity, and the creation of new life forms. Other ethical issues mentioned include the regulation of new creations, patent management of new creations, benefit distribution, and research integrity.

Ethical issues have surfaced for recombinant DNA and genetically modified organism (GMO) technologies and extensive regulations of genetic engineering and pathogen research were in place in many jurisdictions. Amy Gutmann, former head of the Presidential Bioethics Commission, argued that we should avoid the temptation to over-regulate synthetic biology in general, and genetic engineering in particular. According to Gutmann, "Regulatory parsimony is especially important in emerging technologies...where the temptation to stifle innovation on the basis of uncertainty and fear of the unknown is particularly great. The blunt instruments of statutory and regulatory restraint may not only inhibit the distribution of new benefits, but can be counterproductive to security and safety by preventing researchers from developing effective safeguards.".

The "creation" of life

One ethical question is whether or not it is acceptable to create new life forms, sometimes known as "playing God". Currently, the creation of new life forms not present in nature is at small-scale, the potential benefits and dangers remain unknown, and careful consideration and oversight are ensured for most studies. Many advocates express the great potential value—to agriculture, medicine, and academic knowledge, among other fields—of creating artificial life forms. Creation of new entities could expand scientific knowledge well beyond what is currently known from studying natural phenomena. Yet there is concern that artificial life forms may reduce nature's "purity" (i.e., nature could be somehow corrupted by human intervention and manipulation) and potentially influence the adoption of more engineering-like principles instead of biodiversity- and nature-focused ideals. Some are also concerned that if an artificial life form were to be released into nature, it could hamper biodiversity by beating out natural species for resources (similar to how algal blooms kill marine species). Another concern involves the ethical treatment of newly created entities if they happen to sense pain, sentience, and self-perception. Should such life be given moral or legal rights? If so, how?

Ethical support for synthetic biology

Ethics and moral rationales that support certain applications of synthetic biology include their potential mititgation of substantial global problems of detrimental environmental impacts of conventional agriculture (including meat production), animal welfare, food security and human health, as well as potential reduction of human labor needs and, via therapies of diseases, reduction of human suffering and prolonged life.

Biosafety and biocontainment

What is most ethically appropriate when considering biosafety measures? How can accidental introduction of synthetic life in the natural environment be avoided? Much ethical consideration and critical thought has been given to these questions. Biosafety not only refers to biological containment; it also refers to strides taken to protect the public from potentially hazardous biological agents. Even though such concerns are important and remain unanswered, not all products of synthetic biology present concern for biological safety or negative consequences for the environment. It is argued that most synthetic technologies are benign and are incapable of flourishing in the outside world due to their "unnatural" characteristics as there is yet to be an example of a transgenic microbe conferred with a fitness advantage in the wild.

In general, existing hazard controls, risk assessment methodologies, and regulations developed for traditional genetically modified organisms (GMOs) are considered to be sufficient for synthetic organisms. "Extrinsic" biocontainment methods in a laboratory context include physical containment through biosafety cabinets and gloveboxes, as well as personal protective equipment. In an agricultural context they include isolation distances and pollen barriers, similar to methods for biocontainment of GMOs. Synthetic organisms may offer increased hazard control because they can be engineered with "intrinsic" biocontainment methods that limit their growth in an uncontained environment, or prevent horizontal gene transfer to natural organisms. Examples of intrinsic biocontainment include auxotrophy, biological kill switches, inability of the organism to replicate or to pass modified or synthetic genes to offspring, and the use of xenobiological organisms using alternative biochemistry, for example using artificial xeno nucleic acids (XNA) instead of DNA. Regarding auxotrophy, bacteria and yeast can be engineered to be unable to produce histidine, an important amino acid for all life. Such organisms can thus only be grown on histidine-rich media in laboratory conditions, nullifying fears that they could spread into undesirable areas.

Biosecurity

Some ethical issues relate to biosecurity, where biosynthetic technologies could be deliberately used to cause harm to society and/or the environment. Since synthetic biology raises ethical issues and biosecurity issues, humanity must consider and plan on how to deal with potentially harmful creations, and what kinds of ethical measures could possibly be employed to deter nefarious biosynthetic technologies. With the exception of regulating synthetic biology and biotechnology companies, however, the issues are not seen as new because they were raised during the earlier recombinant DNA and genetically modified organism (GMO) debates and extensive regulations of genetic engineering and pathogen research are already in place in many jurisdictions.

European Union

The European Union-funded project SYNBIOSAFE has issued reports on how to manage synthetic biology. A 2007 paper identified key issues in safety, security, ethics and the science-society interface, which the project defined as public education and ongoing dialogue among scientists, businesses, government and ethicists. The key security issues that SYNBIOSAFE identified involved engaging companies that sell synthetic DNA and the biohacking community of amateur biologists. Key ethical issues concerned the creation of new life forms.

A subsequent report focused on biosecurity, especially the so-called dual-use challenge. For example, while synthetic biology may lead to more efficient production of medical treatments, it may also lead to synthesis or modification of harmful pathogens (e.g., smallpox). The biohacking community remains a source of special concern, as the distributed and diffuse nature of open-source biotechnology makes it difficult to track, regulate or mitigate potential concerns over biosafety and biosecurity.

COSY, another European initiative, focuses on public perception and communication. To better communicate synthetic biology and its societal ramifications to a broader public, COSY and SYNBIOSAFE published SYNBIOSAFE, a 38-minute documentary film, in October 2009.

The International Association Synthetic Biology has proposed self-regulation. This proposes specific measures that the synthetic biology industry, especially DNA synthesis companies, should implement. In 2007, a group led by scientists from leading DNA-synthesis companies published a "practical plan for developing an effective oversight framework for the DNA-synthesis industry".

United States

In January 2009, the Alfred P. Sloan Foundation funded the Woodrow Wilson Center, the Hastings Center, and the J. Craig Venter Institute to examine the public perception, ethics and policy implications of synthetic biology.

On July 9–10, 2009, the National Academies' Committee of Science, Technology & Law convened a symposium on "Opportunities and Challenges in the Emerging Field of Synthetic Biology".

After the publication of the first synthetic genome and the accompanying media coverage about "life" being created, President Barack Obama established the Presidential Commission for the Study of Bioethical Issues to study synthetic biology. The commission convened a series of meetings, and issued a report in December 2010 titled "New Directions: The Ethics of Synthetic Biology and Emerging Technologies." The commission stated that "while Venter's achievement marked a significant technical advance in demonstrating that a relatively large genome could be accurately synthesized and substituted for another, it did not amount to the “creation of life”. It noted that synthetic biology is an emerging field, which creates potential risks and rewards. The commission did not recommend policy or oversight changes and called for continued funding of the research and new funding for monitoring, study of emerging ethical issues and public education.

Synthetic biology, as a major tool for biological advances, results in the "potential for developing biological weapons, possible unforeseen negative impacts on human health ... and any potential environmental impact". The proliferation of such technology could also make the production of biological and chemical weapons available to a wider array of state and non-state actors. These security issues may be avoided by regulating industry uses of biotechnology through policy legislation. Federal guidelines on genetic manipulation are being proposed by "the President's Bioethics Commission ... in response to the announced creation of a self-replicating cell from a chemically synthesized genome, put forward 18 recommendations not only for regulating the science ... for educating the public".

Opposition

On March 13, 2012, over 100 environmental and civil society groups, including Friends of the Earth, the International Center for Technology Assessment and the ETC Group issued the manifesto The Principles for the Oversight of Synthetic Biology. This manifesto calls for a worldwide moratorium on the release and commercial use of synthetic organisms until more robust regulations and rigorous biosafety measures are established. The groups specifically call for an outright ban on the use of synthetic biology on the human genome or human microbiome. Richard Lewontin wrote that some of the safety tenets for oversight discussed in The Principles for the Oversight of Synthetic Biology are reasonable, but that the main problem with the recommendations in the manifesto is that "the public at large lacks the ability to enforce any meaningful realization of those recommendations".

Health and safety

The hazards of synthetic biology include biosafety hazards to workers and the public, biosecurity hazards stemming from deliberate engineering of organisms to cause harm, and environmental hazards. The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals, although novel synthetic organisms may have novel risks. For biosecurity, there is concern that synthetic or redesigned organisms could theoretically be used for bioterrorism. Potential risks include recreating known pathogens from scratch, engineering existing pathogens to be more dangerous, and engineering microbes to produce harmful biochemicals. Lastly, environmental hazards include adverse effects on biodiversity and ecosystem services, including potential changes to land use resulting from agricultural use of synthetic organisms. Synthetic biology is an example of a dual-use technology with the potential to be used in ways that could intentionally or unintentionally harm humans and/or damage the environment. Often "scientists, their host institutions and funding bodies" consider whether the planned research could be misused and sometimes implement measures to reduce the likelihood of misuse.

Existing risk analysis systems for GMOs are generally considered sufficient for synthetic organisms, although there may be difficulties for an organism built "bottom-up" from individual genetic sequences. Synthetic biology generally falls under existing regulations for GMOs and biotechnology in general, and any regulations that exist for downstream commercial products, although there are generally no regulations in any jurisdiction that are specific to synthetic biology.

Nonverbal learning disorder

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