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UNIT-IV Recent advancement in biosciences and biotechnology Environmental Biotechnology The application of Biotechnology to solve the environmental problems in the environment and in the ecosystems is called Environmental Biotechnology. It is applied and it is used to study the natural environment. According to the international Society for environmental Biotechnology the environmental Biotechnology is defined as an environment that helps to develop, efficiently use and regulate the biological systems and prevent the environment from pollution or from contamination of land, air and water have work efficiently to sustain an environment â€" friendly Society. In other words, it can be defined as the optimal use of the natural resources through the plants, animals, bacteria, fungi and algae in order to produce the energy that comes from the resources which are natural such as sunlight, wind, air, waves (renewal able energy), food and nutrients. The optimal use of the these natural resources can be done by re-cycling and utilizing the waste from these resources and find unique ways of creating processes to utilize the waste and where the waste of each process created becomes the feedstock for another process.

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UNIT-IV

Recent advancement in biosciences and biotechnology

  Environmental Biotechnology The application of Biotechnology to solve the environmental

problems in the environment and in the ecosystems is called Environmental Biotechnology.

It is applied and it is used to study the natural environment. According to the international Society for environmental Biotechnology the environmental Biotechnology is defined as an environment that helps to develop, efficiently use and regulate the biological systems and prevent the environment from pollution or from contamination of land, air and water have work efficiently to sustain an environment â€" friendly Society.

In other words, it can be defined as the optimal use of the natural resources through the plants, animals, bacteria, fungi and algae in order to produce the energy that comes from the resources which are natural such as sunlight, wind, air, waves (renewal able energy), food and nutrients.

The optimal use of the these natural resources can be done by re-cycling and utilizing the waste from these resources and find unique ways of creating processes to utilize the waste and where the waste of each process created becomes the feedstock for another process.

Applications Of Biotech On Agriculture Biotechnology is frequently deliberated the similar with the

biomedical investigate, but there are a group of other industries which take advantage of biotech method for studying, cloning and varying genes.

We have turn out to be familiar to the thought of enzymes in our everyday lives and a lot of people are recognizable with the argument adjacent the use of GMOs in our foods.

The agricultural industry is at the middle of that debate, but since the days of George Washington Carver, agricultural biotech has been producing innumerable new products that have the possible to alter our lives for the improved.

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1. Vaccines Oral vaccines have been in the works for much existence as a

likely solution to the increase of disease in immature countries, where costs are excessive to extensive vaccination.

Hereditarily engineered crops, frequently fruits or vegetables, planned to carry antigenic proteins from transferable pathogens that will activate an immune reply when injected.

An example of this is a patient-specific vaccine for treating cancer. An anti-lymphoma vaccine has been made using tobacco plants carrying RNA from cloned malignant B-cells. The resultant protein is then used to vaccinate the patient and boost their immune system beside the cancer. Tailor-made vaccines for cancer treatment have shown substantial promise in preliminary studies.

2. AntibioticsPlants are used to create antibiotics for both human and animal use. An expressing antibiotic protein in stock feed, fed straight to animals, is less expensive than traditional antibiotic production, but this practice raise many bioethics issues, because the result is widespread, possibly needless use of antibiotics which may encourage expansion of antibiotic-resistant bacterial strain. Quite a few rewards to using plants to create antibiotics for humans are condensed costs due to the larger quantity of product that can be produced from plants versus a fermentation unit, ease of purification, and condensed risk of contamination compared to that of using mammalian cells and culture media..

3. FlowersThere is extra to agricultural biotechnology than just hostility disease or civilizing food quality. There is some simply aesthetic application and an example of this is the use of gene recognition and transfer techniques to improve the color, smell, size and other features of flowers.Similarly, biotech has been used to make improvement to other common ornamental plants, in particular, shrubs and trees. Some of these changes are similar to those made to crops, such as enhancing cold confrontation of a breed of tropical plant, so it can be grown in northern gardens.

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4. BiofuelsThe agricultural industry plays a big role in the biofuels industry, as long as the feedstock's for fermentation and cleansing of bio-oil, bio-diesel and bio-ethanol. Genetic engineering and enzyme optimization technique are being used to develop improved quality feedstocks for more efficient change and higher BTU outputs of the resulting fuel products. High-yielding, energy-dense crops can minimize relative costs associated with harvesting and transportation (per unit of energy derived), resulting in higher value fuel products.

5. Plant and Animal ReproductionEnhancing plant and animal behavior by traditional methods like cross-pollination, grafting, and cross-breeding is time-consuming. Biotech advance let for specific changes to be made rapidly, on a molecular level through over-expression or removal of genes, or the introduction of foreign genes.The last is possible using gene expression control mechanism such as specific gene promoters and transcription factors. Methods like marker-assisted selection improve the efficiency of "directed" animal breeding, without the controversy normally associated with GMOs. Gene cloning methods must also address species differences in the genetic code, the presence or absence of introns and post-translational modifications such as methylation.

6. Pesticide-Resistant CropsNot to be mystified with pest-resistance, these plants are broadminded of pesticides, allow farmers to selectively kill nearby weeds with no harming their crop. The most well-known example of this is the Roundup-Ready technology, urbanized by Monsanto.First introduced in 1998 as GM soybeans, Roundup-Ready plants are unaffected by the herbicide glyph sate, which can be applied in copious quantity to get rid of any other plants in the field. The profit to this is savings in time and costs associated with conservative tillage to reduce weeds, or multiple applications of different types of herbicides to selectively eliminate exact species of weeds. The probable drawbacks include all the controversial arguments against GMOs.

7. Nutrient Supplementation

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In an attempt to get better human health, mainly in immature countries, scientists are creating hereditarily distorted foods that hold nutrients known to help fight disease or starvation. An example of this is Golden Rice, which contain beta-carotene, the forerunner for Vitamin A manufacture in our bodies. People who eat the rice create more Vitamin A, and necessary nutrient lacking in the diets of the poor in Asian countries.Three genes, two from daffodils and one from a bacterium, proficient of catalyzing four biochemical reactions, were cloned into rice to make it "golden". The name comes from the color of the transgenic grain due to over expression of beta-carotene, which gives carrots their orange color.

8. A biotic strain confrontationA lesser quantity of than 20% of the earth is arable land but some crops have been hereditarily altered to make them more liberal of conditions like salinity, cold and drought. The detection of genes in plants in charge for sodium uptake has lead to growth of knock-out plants able to grow in high salt environments. Up- or down-regulation of record is usually the method used to alter drought-tolerance in plants. Corn and rapeseed plants, capable to thrive under lack conditions, are in their fourth year of field trials in California and Colorado, and it is predictable that they'll reach the marketplace in 4-5 years.

9. Manufacturing power FibersSpider silk is the strongest fiber known to man, stronger than kevlar (used to make bullet-proof vests), with an advanced tensile power than steel. In August 2000, Canadian company Nexia announces growth of transgenic goats that formed spider silk proteins in their milk. While this solved the trouble of mass-producing the proteins, the agenda was shelve when scientists couldn't figure out how to spin them into fibers like spiders do.By 2005, the goats be up for sale to anyone who would take them. While it seem the spider silk design has been put on the shelf for the time-being, it is a technology that is sure to appear again in the future, once more information is gather on how the silks are woven.

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Biotechnology and Human Health

The world has witnessed extraordinary advances in science over the last few decades. Biotechnology - one such area of growth - is an umbrella term covering a broad spectrum of scientific applications used in many sectors, such as health and agriculture. It involves the use of living organisms, or parts of living organisms, to provide new methods of production and make new products. From new vaccines to prevent disease to genetically modified plants with resistance to pests; from replacement heart valves that are better accepted by the body to treatments for human infertility; and from bacteria capable of cleaning up oil spills to environmentally friendly biofuels - biotechnology (sometimes also referred to as life sciences, genetic modification, or genomics), like any new technology, offers us potential benefits and potential risks.

Health Canada's Role

Health Canada's mission is to help Canadians maintain and improve their health. It is our responsibility to:

develop national health policy in partnership with the provinces and territories; enforce health regulations; evaluate the safety and effectiveness of health products, and the safety of food; assess the human health risks of environmental products; monitor potential long-term health trends associated with health products and food; and promote disease prevention and healthy living.

For products of biotechnology, our responsibilities are the same. With a rigorous system in place to regulate and assess products, Health Canada's paramount concern is the health and safety of Canadians and our environment.

If, in its scientific assessment, Health Canada has any concerns about the safety of a product, it is not approved for sale in Canada. The 21st century, with its rapid scientific and technological development, may require new approaches to how we regulate. Smart regulation should support both social and economic achievement - providing consumers with the protection they need to feel safe, supporting sustainability, encouraging a more dynamic economy and creating opportunities for Canadians and a model of regulatory excellence in the world.

In support of its role regulating biotechnology, Health Canada funds research in a variety of areas, such as health policy, regulation, population and public health, healthy environments and consumer safety, and health products and food.

Examples of Products of Biotechnology Regulated by Health Canada

Genetically-modified (GM) foods

corn soybeans cotton seed potatoes flax tomatoes sugar beets squash canola

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papaya rice

Biotechnology-derived Health Products

Therapeutic agents

recombinant blood products cytokines monoclonal antibodies interferons insulins tissue engineered products such as bone grafts, heart valves, xenografts, and collagen agents used in gene therapies molecular farming products

Diagnostic and preventative agents

Drugs and medical devices derived from biotechnology such as:

diagnostic test kits viral, bacterial and rickettsial vaccines radiolabelled biotherapeutics used for diagnosis and imaging

Environmental products

bioremediation, the use of bacteria to clean up environmental contaminants, such as oil spills

biomass conversion, such as converting plant waste to ethanol for use as biofuels biological enzymes, such as those used by the pulp and paper industry biological drain cleaners and grease trap cleaners

Bio-based pest control products

biological herbicides insecticides fungicides

A Seven to Ten Year Process for New Biotechnology Products to Reach the Canadian Market

Assessing the Safety of GM Foods

Health Canada scientists, with individual expertise in molecular biology, toxicology, chemistry, nutritional sciences and microbiology, look at the process used to develop a GM food. They assess the chemical and nutritional composition of the food and whether or not there is the presence of, or potential for production of a toxin or allergenic substance in the food. As well, GM foods are assessed for any potential risk to human health through environmental exposure to them. Only if all of Health Canada's stringent criteria are met, is a GM food approved for sale in Canada.

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Safe and Effective Health Products

Health products subject to the Food and Drugs Act, such as drugs, including those derived from biotechnology, are strictly regulated by Health Canada. Health Canada works to maximize the safety, quality and effectiveness of biologics such as vaccines, gene therapies and reproductive technologies.

Evaluation of Pest Control Products

Before any herbicide, insecticide and fungicide - including those derived from biotechnology - is considered for registration in Canada, it must undergo extensive testing to determine the pesticide's value for managing pests and any potential risks it may pose to human health and the environment.

Assessing Environmental Products

Biotechnology-derived environmental products, such as microorganisms used to clean up an oil spill, are subject to the Canadian Environmental Protection Act. Health Canada shares responsibility with Environment Canada for the risk assessment of these products, including assessment of risks to human health through environmental exposure to them and environmental impact of the product. Assessment takes place prior to manufacture or import, and for some substances, at the research and development stage. If a risk is identified, measures are taken to reduce it by controlling or even banning the substance or product.

Bt cottonBt cotton is a genetically modified organism (GMO) cotton variety, which produces an insecticide to bollworm. It is produced by Monsanto.

Description Strains of the bacterium Bacillus thuringiensis produce over 200 different Bt toxins, each

harmful to different insects. Most notably, Bt toxins are insecticidal to the larvae of moths and butterflies, beetles, cotton bollworms and ghtu flies but are harmless to other forms of life.

 The gene coding for Bt toxin has been inserted into cotton, causing it to produce this natural insecticide in its tissues. In many regions, the main pests in commercial cotton are lepidopteran larvae, which are killed by the Bt protein in the transgenic cotton they eat.

However, Bt cotton is ineffective against many cotton pests such as plant bugs, stink bugs, and aphids; depending on circumstances it may be desirable to use insecticides in prevention. A 2006 study done by Cornell researchers, the Center for Chinese Agricultural Policy and the Chinese Academy of Science on Bt cotton farming in China found that after seven years these secondary pests that were normally controlled by pesticide had increased, necessitating the use of pesticides at similar levels to non-Bt cotton and causing less profit for farmers because of the extra expense of GM seeds.

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Mechanism Bt cotton was created through the addition of genes encoding toxin crystals in the Cry group

of endotoxin.  When insects attack and eat the cotton plant the Cry toxins are dissolved due to the high pH

level of the insects stomach. The dissolved and activated Cry molecules bond to cadherin-like proteins on cells

comprising the brush border molecules.  The epithelium of the brush border membranes separates the body cavity from the gut whilst

allowing access for nutrients. The Cry toxin molecules attach themselves to specific locations on the cadherin-like proteins

present on the epithelial cells of the midge and ion channels are formed which allow the flow of potassium.

Regulation of potassium concentration is essential and, if left unchecked, causes death of cells. Due to the formation of Cry ion channels sufficient regulation of potassium ions is lost and results in the death of epithelial cells. The death of such cells creates gaps in the brush border membrane.

AdvantagesBt cotton has several advantages over non Bt cotton. The important advantages of Bt cotton are briefly pointed out as bellow:

Increases yield of cotton due to effective control of three types of bollworms, viz. American, Spotted and Pink bollworms.

Insects belonged to Lepidoptera (Bollworms) are sensitive to crystalline endotoxic protein produced by Bt gene which in turn protects cotton from bollworms.

Reduction in pesticide use in the cultivation of Bt cotton in which bollworms are major pests.

Reduction in the cost of cultivation and lower farming risks.

Reduction in environmental pollution by the use of insecticides rarely.

Bt cotton exhibit genetic resistance or inbuilt resistance which is a permanent type of resistance and not affected by environmental factors. Thus protects crop from of bollworms.

Bt cotton is ecofriendly and does not have adverse effect on parasites, predators, beneficial insecticides and organisms present in soil.

It promotes multiplication of parasites and predators which help in controlling the bollworms by feeding on larvae and eggs of bollworm.

No health hazards due to rare use of insecticides (particularly who is engaged in spraying of insecticides).

Bt cotton are early in maturing as compared to non Bt cotton.

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Disadvantages[edit]

Bt cotton has several advantages but it has some limitations also, which were given as below;

High cost of Bt cotton seeds as compared to non Bt cotton seeds.

Effectiveness up to 120 days, after that the toxin producing efficiency of the Bt gene drastically reduces.

Adverse effect on insecticide manufacturing companies due to reduced use of pesticides.

Adverse effect on the employment of those persons engaged in pesticide industries.

Ineffective against sucking pests like jassids, aphids, whitefly etc.

Potential adulterant malpractices such as mixing of lowcost non Bt cotton seeds with high cost Bt cotton seeds. The sale of this mixture could affect cotton production.

In IndiaBt cotton is supplied in India's Maharashtra state by the agri-biotechnology company, Mahyco, as the distributor.[4]

The use of Bt cotton in India has grown exponentially since its introduction. Recently India has become the number one global exporter of cotton and the second largest cotton producer in the world.

India has bred Bt-cotton varieties such as Bikaneri Nerma and hybrids such as NHH-44, setting up India to benefit now and well into the future.[5]

Socio-economic surveys confirm that Bt cotton continues to deliver significant and multiple agronomic, economic, environmental and welfare benefits to Indian farmers and society including halved insecticide requirements and a doubling of yields. [6]

However, India’s success has been subject to scrutiny. Monsanto's seeds are expensive and lose vigour after one generation, prompting the Indian Council of Agricultural Research to develop a cheaper Bt cotton variety with seeds that could be reused.

The cotton incorporated the cry1Ac gene from the soil bacterium Bacillus thuringiensis (Bt), making the cotton toxic to bollworms. This variety showed poor yield, was removed within a year, and contained a DNA sequence owned by Monsanto, prompting an investigation. [7] In parts of India cases of acquired resistance against Bt cotton have occurred.

Monsanto has admitted that the pink bollworm is resistant to first generation transgenic Bt cotton that expresses the single Bt gene (Cry1Ac)

The state of Maharashtra has banned the sale and distribution of Bt cotton in 2012, to promote local Indian seeds, which demand less water, fertilizers and pesticide input.

Advantages

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The main selling points of Bt cotton are the reductions in pesticides to be sprayed on a crop and the ecological benefits which stem from that. China first planted Bt cotton in 1997 specifically in response to an outbreak of cotton bollworm, Helicoverpa armigera, that farmers were struggling to control with conventional pesticides.[10] Similarly in India and the US, Bt cotton initially alleviated the issues with pests whilst increasing yields and delivering higher profits for farmers.

Studies showed that the lower levels of pesticide being sprayed on the cotton crops promoted biodiversity by allowing non-target species like ladybirds, lacewings and spiders to become more abundant.

 Likewise it was found that integrated pest management strategies (IPM) were becoming more effective due to the lower levels of pesticide encouraging the growth of natural enemy populations.

stem cellStem cells are undifferentiated biological cells that can differentiate into specialized cells and can divide (through mitosis) to produce more stem cells. They are found in multicellular organisms. In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues. In adultorganisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues. In a developing embryo, stem cells can differentiate into all the specialized cells—ectoderm, endoderm and mesoderm (see induced pluripotent stem cells)—but also maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal tissues.

There are three known accessible sources of autologous adult stem cells in humans:

1. Bone marrow, which requires extraction by harvesting, that is, drilling into bone (typically the femur or iliac crest).

2. Adipose tissue (lipid cells), which requires extraction by liposuction.

3. Blood, which requires extraction through apheresis, wherein blood is drawn from the donor (similar to a blood donation), and passed through a machine that extracts the stem cells and returns other portions of the blood to the donor.

PropertiesThe classical definition of a stem cell requires that it possess two properties:

Self-renewal: the ability to go through numerous cycles of cell division while maintaining the undifferentiated state.

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Potency: the capacity to differentiate into specialized cell types. In the strictest sense, this requires stem cells to be either totipotent or pluripotent—to be able to give rise to any mature cell type, although multipotent or unipotent progenitor cells are sometimes referred to as stem cells. Apart from this it is said that stem cell function is regulated in a feed back mechanism.

(Pluripotent, embryonic stem cells originate as inner cell mass (ICM) cells within a blastocyst.

These stem cells can become any tissue in the body, excluding a placenta. Only cells from an

earlier stage of the embryo, known as the morula, are totipotent, able to become all tissues in the

body and the extraembryonic placenta.)

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Stem cells are mother cells that have the potential to become any type of cell in the body. One of the main characteristics of stem cells is their ability to self-renew or multiply while maintaining the potential to develop into other types of cells. Stem cells can become cells of the blood, heart, bones, skin, muscles, brain etc. There are different sources of stem cells but all types of stem cells have the same capacity to develop into multiple types of cells.

Stem cells (center ones) can develop into any cell type. They are valuable as research tools and might, in the future, be used to treat a wide range of diseases. 

Types of stem cells

Pluripotent Stem Cells (PS cells)

These possess the capacity to divide for long periods and retain their ability to make all cell types within the organism. The best known type of pluripotent stem cell is the one present in embryos that helps babies grow within the womb. These are termedembryonic stem cells. These cells form at the blastocyst stage of development. A blastocyst is a hollow ball of cells

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that is smaller than a pinhead. The embryonic stem cells lie within this ball of cells. Recent research has enabled scientists to derive pluripotent cells from adult human skin cells. These are termed induced pluripotent stem cells or iPS cells.

Fetal stem cells

These are obtained from tissues of a developing human fetus. These cells have some characteristics of the tissues they are taken from. For example, those taken from fetal muscles can make only muscle cells. These are also called progenitor cells.

Adult stem cells

These are obtained from some tissues of the adult body. The most commonly used example is the bone marrow. Bone marrow is a rich source of stem cells that can be used to treat some blood diseases and cancers.

Discovery of stem cells

Scientists first studied the potential of stem cells in mouse embryos over two decades ago. Over years of research they discovered the properties of these stem cells in 1998. They found methods to isolate stem cells from human embryos and grow the cells in the laboratory.

Early studies utilized embryos created for infertility purposes through in vitro fertilization procedures and when they were no longer needed for that purpose. The use required voluntary donation of the embryos by the owners.

Potential for use

Stem cell research is improving by leaps and bounds. These may soon become the basis for treating diseases such as Parkinson's disease, diabetes, heart failure, cerebral palsy, heart disease and host of other chronic ailments.

Stem cells may also be used for screening new drugs and toxins and understanding birth defects without subjecting human volunteers to the toxins and drugs.

Gene therapyGene therapy is an experimental technique that uses genes to treat or prevent disease. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient's cells instead of using drugs or surgery.

Gene therapy is the therapeutic delivery of nucleic acid polymers into a patient's cells as a drug to treat disease. Gene therapy could be a way to fix a

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genetic problem at its source. The polymers are either expressed as proteins, interfere withprotein expression, or possibly correct genetic mutations.

The most common form uses DNA that encodes a functional, therapeutic gene to replace a mutated gene. The polymer molecule is packaged within a "vector", which carries the molecule inside cells.

Gene therapy was conceptualized in 1972, by authors who urged caution before commencing human gene therapy studies. The first gene therapy experiment approved by the US Food and Drug Administration (FDA) occurred in 1990, when Ashanti DeSilva was treated for ADA-SCID.[1] By January 2014, some 2,000 clinical trials had been conducted or approved.

Cell typesGene therapy may be classified into two types:

Somatic cell

In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any of any cell other than a gamete, germ cell, gametocyte or undifferentiated stem cell.

Any such modifications affect the individual patient only, and are not inherited by offspring. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.

Over 600 clinical trials utilizing SCGT are underway in the US. Most focus on severe genetic disorders, including immunodeficiencies, haemophilia, thalassaemia and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy.

The complete correction of a genetic disorder or the replacement of multiple genes is not yet possible. Only a few of the trials are in the advanced stages.

Germline

In germline gene therapy (GGT), germ cells (sperm or eggs) are modified by the introduction of functional genes into their genomes.

Modifying a germ cell causes all the organism's cells to contain the modified gene. The change is therefore heritable and passed on to later generations. Australia, Canada, Germany, Israel, Switzerland and the Netherlands  prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations ] and higher risks versus SCGT. The US has no federal controls specifically addressing human genetic modification (beyond FDA regulations for therapies in general).

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Vectors The delivery of DNA into cells can be accomplished by multiple methods. The two major

classes are recombinant viruses (sometimes called biological nanoparticles or viral vectors) and naked DNA or DNA complexes (non-viral methods).

Viruses

In order to replicate, viruses introduce their genetic material into the host cell, tricking the host's cellular machinery into using it as blueprints for viral proteins. Scientists exploit this by substituting a virus's genetic material with therapeutic DNA. (The term 'DNA' may be an oversimplification, as some viruses contain RNA, and gene therapy could take this form as well.) A number of viruses have been used for human gene therapy, including retrovirus, adenovirus, lentivirus, herpes simplex, vaccinia and adeno-associated virus.[2]Like the genetic material (DNA or RNA) in viruses, therapeutic DNA can be designed to simply serve as a temporary blueprint that is degraded naturally or (at least theoretically) to enter the host's genome, becoming a permanent part of the host's DNA in infected cells.

Non-viral

Non-viral methods present certain advantages over viral methods, such as large scale production and low host immunogenicity. However, non-viral methods initially produced lower levels of transfection and gene expression, and thus lower therapeutic efficacy. Later technology remedied this deficiency[citation needed].

Methods for non-viral gene therapy include the injection of naked DNA, electroporation, the gene gun, sonoporation, magnetofection, the use of oligonucleotides, lipoplexes, dendrimers, and inorganic nanoparticles.

Speculative uses Speculated uses for gene therapy include:

Gene doping

Athletes might adopt gene therapy technologies to improve their performance. [112] Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.

Human genetic engineering

Genetic engineering could be used to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence.

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Ethical claims about germline engineering include beliefs that every fetus has a right to remain genetically unmodified, that parents hold such rights, and that every child has the right to be born free of preventable diseases . For adults, genetic engineering could be seen as another enhancement technique to add to diet, exercise, education, cosmetics and plastic surgery. Another theorist claims that moral concerns limit but do not prohibit germline engineering.

Possible regulatory schemes include a complete ban, provision to everyone, or professional self-regulation. The American Medical Association’s Council on Ethical and Judicial Affairs stated that "genetic interventions to enhance traits should be considered permissible only in severely restricted situations: (1) clear and meaningful benefits to the fetus or child; (2) no trade-off with other characteristics or traits; and (3) equal access to the genetic technology, irrespective of income or other socioeconomic characteristics.

GMOA genetically modified organism (GMO), also known as a transgenic organism, is any organism whose genetic material has been altered using genetic engineering techniques.GMOs are the source of genetically modifiedfoods and are also widely used in scientific research and to produce goods other than food.

ProductionGenetic modification involves the mutation, insertion, or deletion of genes. Inserted genes usually come from a different species in a form of horizontal gene-transfer. In nature this can occur when exogenous DNA penetrates the cell membrane for any reason. To do this artificially may require:

attaching the genes to a virus

physically inserting the extra DNA into the nucleus of the intended host with a very small syringe

with the use of electroporation (that is, introducing DNA from one organism into the cell of another by use of an electric pulse)

with very small particles fired from a gene gun.

Other methods exploit natural forms of gene transfer, such as the ability of Agrobacterium to transfer genetic material to plants,[4] or the ability of lentiviruses to transfer genes to animal cells.

HistoryHumans have domesticated plants and animals since around 12,000 BCE, using selective breeding or artificial selection (as contrasted with natural selection). The process ofselective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed

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the next generation and organisms lacking the trait are not bred, is a precursor to the modern concept of genetic modification.[7]:1[8]:1 When nucleic acid sequences are combined in a laboratory, the resulting DNA is called recombinant DNA.[9]Recombinant DNA may contain oligonucleotides from the same or similar species, in which case it is called "cisgenic", or may contain oligonucleotides from different organisms that could not naturally interbreed, in which case it is called "transgenic".[10] Recombinant DNA may also contain synthetic sequences.

UsesGMOs are used in biological and medical research, production of pharmaceutical drugs, experimental medicine (e.g. gene therapy), and agriculture (e.g. golden rice, resistance to herbicides). The term "genetically modified organism" does not always imply, but can include, targeted insertions of genes from one species into another. For example, a gene from a jellyfish, encoding a fluorescent protein called GFP, or green fluorescent protein, can be physically linked and thus co-expressed with mammalian genes to identify the location of the protein encoded by the GFP-tagged gene in the mammalian cell. Such methods are useful tools for biologists in many areas of research, including those who study the mechanisms of human and other diseases or fundamental biological processes in eukaryotic or prokaryotic cells.

Microbes

Bacteria were the first organisms to be modified in the laboratory, due to their simple genetics.[14]

They continue to be important model organisms for experiments in genetic engineering. In the field of synthetic biology, they have been used to test various synthetic approaches, from synthesizing genomes to creating novel nucleotides.

These organisms are now used for several purposes, and are particularly important in producing large amounts of pure human proteins for use in medicine.[18]

Genetically modified bacteria are used to produce the protein insulin to treat diabetes. Similar bacteria have been used to produce biofuels,[20] clotting factors to treathaemophilia,[21] and human growth hormone to treat various forms of dwarfism.

In addition, various genetically engineered micro-organisms are routinely used as sources of enzymes for the manufacture of a variety of processed foods. These include alpha-amylase from bacteria, which converts starch to simple sugars, chymosin from bacteria or fungi, which clots milk protein for cheese making, and pectinesterase from fungi, which improves fruit juice clarity.

Human gene therapy

Gene therapy, uses genetically modified viruses to deliver genes that can cure disease in humans. Although gene therapy is still relatively new, it has had some successes. It has been used to treat genetic disorders such as severe combined immunodeficiency, and Leber's congenital

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amaurosis.Treatments are also being developed for a range of other currently incurable diseases, such as cystic fibrosis, sickle cell anemia,Parkinson's disease,cancer,diabetes,heart disease

and muscular dystrophy.

Fish

Genetically modified fish are used for scientific research and as pets, and are being considered for use as food and as aquatic pollution sensors.

GM fish are widely used in basic research in genetics and development. Two species of fish, zebrafish and medaka, are most commonly modified because they have optically clear chorions (membranes in the egg), rapidly develop, and the 1-cell embryo is easy to see and microinject with transgenic DNA

The GloFish is a patented  brand of genetically modified (GM) fluorescent zebrafish with bright red, green, and orange fluorescent color. Although not originally developed for the ornamental fish trade, it became the first genetically modified animal to become publicly available as a pet when it was introduced for sale in 2003. They were quickly banned for sale in California.

InvertebratesFruit flies

In biological research, transgenic fruit flies (Drosophila melanogaster) are model organisms used to study the effects of genetic changes on development.Fruit flies are often preferred over other animals due to their short life cycle, low maintenance requirements, and relatively simple genome compared to many vertebrates.

Mosquitoes

In 2010, scientists created "malaria-resistant mosquitoes" in the laboratory. The World Health Organization estimated that malaria killed almost one million people in 2008. Genetically modified male mosquitoes containing a lethal gene have been developed to combat the spread of dengue fever. Aedes aegypti mosquitoes, the single most important carrier of dengue fever, were reduced by 80% in a 2010 trial of these GM mosquitoes in the Cayman Islands. Between 50 and 100 million people are affected by dengue fever every year and 40,000 people die from it.[

Bollworms

A strain of Pectinophora gossypiella (Pink bollworm) has been genetically engineered to express a red fluorescent protein. This allows researchers to monitor bollworms that have been sterilized by radiation and released to reduce bollworm infestation. The strain has been field tested for over three years and has been approved for release.[103][104][105]

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Cnidarians

Cnidarians such as Hydra and the sea anemone Nematostella vectensis have become attractive model organisms to study the evolution of immunity and certain developmental processes. An important technical breakthrough was the development of procedures for generation of stably transgenic hydras and sea anemones by embryo microinjection.

Regulation The regulation of genetic engineering concerns the approaches taken by governments to

assess and manage the risks associated with the use of genetic engineering technology and the development and release of genetically modified organisms (GMO), including genetically modified crops and genetically modified fish.

There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe.] Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.

The European Union differentiates between approval for cultivation within the EU and approval for import and processing. While only a few GMOs have been approved for cultivation in the EU a number of GMOs have been approved for import and processing.

Bio ethicsBioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in biology and medicine. It is also moral discernment as it relates to medical policy, practice, and research. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences,biotechnology, medicine, politics, law, and philosophy. It also includes the study of the more commonplace questions of values ("the ethics of the ordinary") which arise in primary care and other branches of medicine.

HistoryEtymology

The term Bioethics (Greek bios, life; ethos, behavior) was coined in 1926 by Fritz Jahr, who "anticipated many of the arguments and discussions now current in biological research involving animals" in an article about the "bioethical imperative," as he called it, regarding the scientific use of animals and plants.[1] In 1970, the American biochemistVan Rensselaer Potter also used the term with a broader meaning including solidarity towards the biosphere, thus generating a "global ethics,"

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a discipline representing a link between biology, ecology, medicine and human values in order to attain the survival of both human beings and other animal species

Purpose and scope The field of bioethics has addressed a broad swathe of human inquiry, ranging from debates

over the boundaries of life (e.g. abortion, euthanasia), surrogacy, the allocation of scarce health care resources (e.g. organ donation, health care rationing) to the right to refuse medical care for religious or cultural reasons.

Bioethicists often disagree among themselves over the precise limits of their discipline, debating whether the field should concern itself with the ethical evaluation of all questions involving biology and medicine, or only a subset of these questions.

 Some bioethicists would narrow ethical evaluation only to the morality of medical treatments or technological innovations, and the timing of medical treatment of humans. Others would broaden the scope of ethical evaluation to include the morality of all actions that might help or harm organisms capable of feeling fear.

The scope of bioethics can expand with biotechnology, including cloning, gene therapy, life extension, human genetic engineering, astroethics and life in space,[5] and manipulation of basic biology through altered DNA, XNA and proteins.[6] These developments will affect future evolution, and may require new principles that address life at its core, such as biotic ethics that values life itself at its basic biological processes and structures, and seeks their propagation.

Principles One of the first areas addressed by modern bioethicists was that of human experimentation.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was initially established in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.

However, the fundamental principles announced in the Belmont Report (1979)—namely, autonomy, beneficence and justice—have influenced the thinking of bioethicists across a wide range of issues. Others have added non-maleficence, human dignity and the sanctity of life to this list of cardinal values.

Another important principle of bioethics is its placement of value on discussion and presentation.

Numerous discussion based bioethics groups exist in universities across the United States to champion exactly such goals. Examples include the Ohio State Bioethics Society and the Bioethics Society of Cornell. Professional level versions of these organizations also exist.

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Medical ethics Medical ethics is the study of moral values and judgments as they apply to medicine. As a

scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.

Medical ethics tends to be understood narrowly as an applied professional ethics, whereas bioethics appears to have worked more expansive concerns, touching upon thephilosophy of science and issues of biotechnology.

Still, the two fields often overlap and the distinction is more a matter of style than professional consensus.

Medical ethics shares many principles with other branches of healthcare ethics, such as nursing ethics.

A bioethicist assists the health care and research community in examining moral issues involved in our understanding of life and death, and resolving ethical dilemmas in medicine and science.