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Category Archives: Genetic Engineering

Viral Vector and Plasmid DNA Testing Services Market Players focusing on the invention of new techniques in a bid to better the characterization of…

Posted: June 13, 2020 at 12:45 am

The global viral vector and plasmid DNA testing services market is estimated to be influenced by the increased innovation and spending in research and development activities relating to the field. Viral vectorsare those tools that are popular amongst the molecular biologists and they make wide use of these tools to deliver genetic materials into cells. This same procedure can be conducted in cell culture (in vitro) or inside a living organism (in vivo). Viruses have developed into specialized molecular mechanisms in a bid to carry their genomes inside the cells that they infect. On the other hand, plasmids are small DNA molecules, which are separated physically from the chromosomal DNA and then they are able to replicate on their own. Abundantly found in bacteria as double-stranded, circular DNA molecules, these organisms are utilized widely in laboratories of biotechnology and genetic engineering. It is there where they are utilized for the purpose of amplifying and cloning or expressing certain types of genes.

The players in the global viral vector and plasmid DNA testing services market are increasingly focusing on the invention of new techniques in a bid to better the characterization of viral vectors is estimated drive the demand for the testing services over the period of analysis, from 2019 to 2029.

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The global viral vector and plasmid DNA testing services market has been segmented based on testing services, end user, and region. The main objective of providing such a comprehensive report is to provide a deep insight into the market.

Global Viral Vector and Plasmid DNA Testing Services market: Notable Developments

The global viral vector and plasmid DNA testing services market has witnessed some of the major developments in the last few years. One such significant development of the market is mentioned below:

Some of the key market players of the viral vector and plasmid DNA testing services market comprise the following

Global Viral Vector and Plasmid DNA Testing Services Market: Growth Drivers

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Inorganic Growth Strategies Likely to Shape Contours of the Market

Viral vectors are customized as per their requirements in certain specific applications but these vectors usually come with a few key characteristics, such as safety, low toxicity, stability, cell type specificity, and identification. These properties of viral vectors are likely to play an important role in supporting growth of the global viral vector and plasmid DNA testing services market. Viral vectors are seldom created from pathogenic viruses and they are altered in such a way that the risk of handling is minimized. Besides, viral vector causes no or minimal effect on the physiology of the infected cell.

A rise in the focus of market players on the development of innovative technologies in an attempt to improve characterization of viral vectors is likely to encourage development of the global viral vector and plasmid DNA testing services market in the years to come. A case in point is the development of Vac-Man 96 Vacuum Manifold by US-based Promega Corporation. This invention supports the processing of SV 96 plates for PCR product, genomic, and plasmid purification. The product finds utilization in Wizard SV 96 plasmid DNA purification system to isolate plasmid DNA.

Global Viral Vector and Plasmid DNA Testing Services market: Regional Outlook

In the global viral vector and plasmid DNA testing services market, North America is likely to emerge as one of the prominent regions in market. Such growth of the region is attributed to the various inorganic growth strategies taken by market players such as acquisitions, partnerships, and mergers. These strategies are taken to strengthen and widen the product portfolio of the market players present in the region. This factor is likely to boost the growth of the North America in the years to come.

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The global viral vector and plasmid DNA testing services market is segmented as:

Testing Services

End User

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GM seeds: the debate, and a sowing agitation – The Indian Express

Posted: at 12:45 am

Written by Parthasarathi Biswas | Pune | Updated: June 12, 2020 12:56:06 pm Genetic engineering aims to transcend the genus barrier by introducing an alien gene in the seeds to get the desired effects. (File Photo)

Last week, Shetkari Sanghatana the farmers union founded by the late leader Sharad Joshi announced fresh plans in its agitation for use of genetically modified seeds. In the current kharif season, farmers would undertake mass sowing of GM seeds for maize, soyabean, mustard brinjal and herbicide tolerant (Ht) cotton, although these are not approved. Farmers had carried out a similar movement last year, too.

What are genetically modified seeds?

Conventional plant breeding involves crossing species of the same genus to provide the offspring with the desired traits of both parents. Genetic engineering aims to transcend the genus barrier by introducing an alien gene in the seeds to get the desired effects. The alien gene could be from a plant, an animal or even a soil bacterium.

Bt cotton, the only GM crop that is allowed in India, has two alien genes from the soil bacterium Bacillus thuringiensis (Bt) that allows the crop to develop a protein toxic to the common pest pink bollworm. Ht Bt, on the other, cotton is derived with the insertion of an additional gene, from another soil bacterium, which allows the plant to resist the common herbicide glyphosate.

In Bt brinjal, a gene allows the plant to resist attacks of fruit and shoot borer.

In DMH-11 mustard, developed by Deepak Pental and colleague in the South Campus of University of Delhi, genetic modification allows cross-pollination in a crop that self-pollinates in nature.

Across the world, GM variants of maize, canola and soyabean, too, are available.

What is the legal position of genetically modified crops in India?

In India, the Genetic Engineering Appraisal Committee (GEAC) is the apex body that allows for commercial release of GM crops. In 2002, the GEAC had allowed the commercial release of Bt cotton. More than 95 per cent of the countrys cotton area has since then come under Bt cotton. Use of the unapproved GM variant can attract a jail term of 5 years and fine of Rs 1 lakh under the Environmental Protection Act ,1989.

Why are farmers rooting for GM crops?

In the case of cotton, farmers cite the high cost of weeding, which goes down considerably if they grow Ht Bt cotton and use glyphosate against weeds. Brinjal growers in Haryana have rooted for Bt brinjal as it reduces the cost of production by cutting down on the use of pesticides.

Unauthorised crops are widely used. Industry estimates say that of the 4-4.5 crore packets (each weighing 400 gm) of cotton sold in the country, 50 lakh are of the unapproved Ht Bt cotton. Haryana has reported farmers growing Bt brinjal in pockets which had caused a major agitation there. In June last year, in a movement led by Shetkari Sanghatana in Akola district of Maharashtra, more than 1,000 farmers defied the government and sowed Ht Bt cotton. The Akola district authorities subsequently booked the organisers.

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Environmentalists argue that the long-lasting effect of GM crops is yet to be studied and thus they should not be released commercially. Genetic modification, they say, brings about changes that can be harmful to humans in the long run.

What is the movement about?

The Sanghatana has announced that this year they are going to undertake large-scale sowing of unapproved GM crops like maize, Ht Bt cotton, soyabean and brinjal across Maharashtra. Farmers who plant such variants will put up boards on their fields proclaiming the GM nature of their crop. Anil Ghanwat, president of the union, has said this action will draw attention to the need for introduction of the latest technology in the fields. He said farmers will not be deterred by any action taken against them by the authorities.

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What scientists are learning about COVID-19 from animals – WISHTV.com

Posted: at 12:45 am

INDIANAPOLIS (WISH) Health experts say a vaccine is the worlds best hope to ending the coronavirus pandemic.

And while there are currently dozens of human clinical trials underway, other trials are enlisting animals. Some are house pets, some live in pastures, and others in tropical rain forests.

Ferrets

Ferrets are vulnerable to many respiratory illnesses found in humans, including lung cancer, cystic fibrosis and the novel coronavirus,thus making them great candidates for experimentation, scientists say.

Researchers now know ferrets can contract and transmit COVID-19. This has a lot to do with how the virus enters the body and attacks the lungs. The mechanism mirrors how COVID-19 attaches to human lungs, scientists say.

Scientists from the Commonwealth Scientific and Industrial Research Organization in Australia have started two pre-clinical trials to test a potential COVID-19 vaccine using the animal.

Monkeys

Scientists from The Jenner Institute at Oxford University began working on a coronavirus vaccine back in 2019. While its not for COVID-19, the virus responsible for this pandemic, its very similar.

The vaccine was tested at the National Institutes of Healths Rocky Mountain Laboratory in Montana. Scientists injected six rhesus monkeys with the 2019 vaccine and then exposed them to the novel coronavirus. Less than a month later, all six monkeys showed no signs of COVID-19.

Cows

Researchers are also looking to cows in an effort to develop a treatment. Scientists at SAB Biotherapeutics in South Dakota, through genetic engineering, created an embryo that contains parts of human chromosomes. The embryo is then implanted into the cow.

The resulting calf then grows into what scientists call a genetically humanized cow. The only overlap between the cow and a person is a portion of their immune system.

The genetically humanized cows are then injected with COVID-19. The cows immune system now similar to a persons would then attack the coronavirus. From there, scientists would look to see if the cows develop antibodies against it. The idea is that these antibodies would then be extracted from the cows blood and used as a drug to combat the coronavirus.

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How Receptive are Consumers to Agricultural Biotech? – Food Institute Focus – Food Institute Blog

Posted: at 12:45 am

After decades of being sidelined by consumers concerned over whether they were safe, foods made with genetically modified organisms, or GMOs, may finally find a place on more meal plates along with other new agricultural biotechnologies aimed at making plants drought- or flood-tolerant and increasing yields.

The changing climate and growing population are pressuring the food system, experts said. At the same time younger generations like Gen Z are interested in the environment and sustainability and are more likely to be open to eating food created with new technologies that could boost yields.

Consumers should think less about the technology and more about what we can do to enhance the sustainability of agriculture, said Pamela Ronald, PhD, professor in the department of plant pathology at the University of California at Davis. There will be different technologies, now and into the future. There is a critical challenge to feed the growing population without destroying the environment.

Dr. Roland and her colleagues developed a rice that can withstand the heavy flooding in Africa and Asia and increase yields. She coauthored a paper entitled Crop Biotechnology and the Future of Food that appeared in the May 19 issue of Nature Food on genetic tools to help increase food production.

By 2050 the global population is predicted to reach 9.7 billion. Meeting this higher food demand, if consumption practices and food waste do not change, requires estimated food production increases of 25% to 200%, she wrote. Cultivated crops using food technologies are part of the solution, she said.

Meanwhile, anti-GMO groups including the Organic Consumers Association in Finland, MN, and the Institute for Agriculture and Trade Policy in Minneapolis, MN, argue there isnt enough research yet on GMOs to assure they are safe to eat.

Some companies even use a non-GMO label as an advantage when marketing to consumers. Meat alternative company Beyond Meat utilized that label to distinguish itself from competitor Impossible Burger, which uses two genetically engineered ingredients: soy leghemoglobin and soy protein.

However, debates over GMO or non-GMO labeling are unlikely to fundamentally change consumers views of GMOs, said William Hallman, PhD, professor and chair of the Department of Human Ecology at Rutgers University, New Brunswick, NJ.

Sales of the Impossible Burger dont appear to be flagging because people are concerned about the fact that it has GMO-based ingredients, he said. In fact, it is more likely that people are attracted to the idea that both the Beyond and Impossible burgers are plant-based, which creates a health halo around the products.

He mentioned most consumers will freely admit they know little about GMOs or gene-editing technologies, so they are not changing their habits about eating GMO foods.

One of the pioneers of GMOs was Norman Borlaug, PhD, who in the 1950s created a disease-resistant, high-yield, semi-dwarf wheat that fed millions of people in Mexico and South Asia.

GMOs continue to be used to relieve famines and get more crop yield out of available land. In January, Zimbabwe quietly lifted its 12-year-old ban on GMO corn in an effort to avert a severe famine, according to Bloomberg News.

The current and anticipated challenges to the food system arent lost in the U.S. Three federal agencies in March got behind an effort to educate consumers about GMOs. The U.S. FDA, USDA, and EPA launched the Feed Your Mind program, which aims to answer questions about what GMOs are, how and why they are made, how they are regulated, and whether they are healthy and safe.

A GMO is a plant, animal, or microorganism that has had its genetic material modified, including transferring DNA from one organism to another. Apples, potatoes, and soybeans are among the many genetically modified foods that are available in supermarkets.

While foods from genetically engineered plants have been available to consumers since the early 1990s and are a common part of todays food supply, there are a lot of misconceptions about them, FDA Commissioner Stephen Hahn, MD, said when the initiative was launched. This initiative is intended to help people better understand what these products are and how they are made. Genetic engineering has created new plants that are resistant to insects and diseases, led to products with improved nutritional profiles, as well as certain produce that dont brown or bruise as easily.

The COVID-19 pandemic could have a role in consumer awareness of potential food shortages, even though distribution issues may be at the root of the problem now, said Oliver Peoples, PhD, president and CEO of Yield10 Bioscience of Woburn, MA, a company that uses the gene-editing technology CRISPR and other technologies to improve crop yields.

The public has gone to the grocery store and seen empty shelves, including basic staples like meats, chicken, and eggs, he said. This has forced many consumers to try genetically modified products that they might have not typically opted to buy before.

Furthermore, the Millennial and Gen Z generations are making a big difference in the acceptability of food made with technology because they are very focused on climate change and sustainability, said Dr. Peoples.

Marketing company Ketchum found that 77% of Gen Z consumers it polled are likely to try food made with technology and 71% are comfortable with its use to grow food (see Food Tech Consumer Perception table below).

This bodes well for food companies, as Gen Z is the newest generation of food consumers with purchasing power, said Bill Zucker, managing director of food at Ketchum.

By Lori Valigra, journalist based in Harrison, ME. Reach her at valigra@gmail.com.

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Egg-based coating preserves fresh produce – Feedstuffs

Posted: at 12:45 am

Eggs that would otherwise be wasted can be used as the base of an inexpensive coating to protect fruits and vegetables, Rice University researchers have discovered.

Brown School of Engineering lab of materials scientist Pulickel Ajayan and colleagues have developed a micron-thick coating that solves problems both for produce and its consumers.

When the coating was applied to produce by spraying or dipping, it showed a remarkable ability to resist rotting for an extended period comparable to standard coatings like wax, but without some of the inherent problems.

The coating provides an outlet for eggs that never reach the market, the researchers suggested, as manufacturers reject 3% of the more than 7 billion eggs produced each year in the U.S. In fact, they estimated that more than 200 million eggs end up in landfills each year.

Reducing food shortages in ways that dont involve genetic modification, inedible coatings or chemical additives is important for sustainable living, Ajayan said. The work is a remarkable combination of interdisciplinary efforts involving materials engineers, chemists and biotechnologists from multiple universities across the U.S.

Along with being edible, the multifunctional coating retards dehydration, provides antimicrobial protection and is largely impermeable both to water vapor to retard dehydration and to gas to prevent premature ripening. The coating is all-natural and washes off with water.

If anyone is sensitive to the coating or has an egg allergy, they can easily eliminate it, Jung said.

Egg whites (albumen) and yolks account for nearly 70% of the coating, the researchers explained. The majority of the rest of the coating consists of nanoscale cellulose extracted from wood -- which serves as a barrier to water and keeps produce from shriveling -- a small amount of curcumin for antimicrobial powers and a splash of glycerol to add elasticity.

Lab tests on dip-coated strawberries, avocadoes, bananas and other fruit showed that they maintained their freshness far longer than uncoated produce. Compression tests showed that coated fruits were significantly stiffer and firmer than uncoated fruits and demonstrated the coatings ability to keep water in the produce, thus slowing the ripening process.

An analysis of freestanding films of the coating showed it to be extremely flexible and able to resist cracking, allowing better protection of the produce. Tests of the films tensile properties showed it to be just as tough as other products, including synthetic films used in produce packaging. Further tests proved the coating to be nontoxic, and solubility tests showed that a thicker-than-usual film is washable. Rinsing in water for a couple of minutes can completely disintegrate it, Ajayan said.

The researchers continue to refine the coatings composition and are considering other source materials.

We chose egg proteins because there are lots of eggs wasted, but it doesnt mean we cant use others, said co-corresponding author Muhammad Rahman, a research scientist in Ajayans Rice lab who mentored and led the team.

Jung noted that the team is testing proteins that could be extracted from plants rather than animal production to make coatings.

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Fat alternative Epogee gains traction: ‘The low-fat ship sailed 25 years ago, this is not about low fat, it’s about caloric reduction’ -…

Posted: at 12:45 am

Products already on the market containing Epogeeinclude enrobed caramel clusters and a fast-growing low-calorie ice cream brand delivering asuper-premium creamy mouthfeel,Epogee chief commercial officer Jayme Caruso told reporters in a briefing on Wednesday.

We have a customer about to launch a peanut spread and a chocolate hazelnut spread with EPG and we expect to see many more products hitting the market with EPG in the coming months.

EPG (esterified propoxylated glycerol) which be listed on food labels as EPG (modified plant-based oil) - can be used to replace up to 85% of the fat in scores of applications from confectionery to baking mixes, said Caruso, who said the FDA had just confirmed it had no objections to extending a GRAS determination for EPG to include potato chips, corn-based savory snacks, chicken nuggets, plant-based protein products, dairy analogs, and beverages/beverage bases.

To make EPG, the company splits rapeseed oil (although other vegetable oils can also be used) into glycerin and fatty acid, inserts a food-grade link, and reconnects them (see box below for details).

The modified fat (EPG) has a high melting point of 102F, which means that it doesnt liquify when it passes through the body (which typically has a temperature of around 98.6F) and has the consistency of soft candlewax, Caruso told FoodNavigator-USA.

It largely resists digestion because digestive enzymes are prevented from breaking it down, so hardly any of its calories are released, added Caruso, who is talking to potential partners from leading CPG brands to disruptive startups.

To put this into perspective, 1g of fat contains 9 calories, while 1g of Epogee contains 0.7 calories.

Unlike Olestra (which had a lower melting point and messy side effects) or fat replacers made from sugars, gums, starches or fibers (which provide bulking, humectancy and mouthfeel but many firms dont want to include on the ingredients list), EPG functions like fat in food products and in the human body because its made from fat, said Caruso.

In a nutshell, he said, EPG is unique in the food formulation space because its analternative fat, not a fat substitute EPG looks feels, tastes, and functions like fat because its made from fat, it just doesnt deliver the calories.

While fat reduction and replacement might have been all the rage in the 80s and 90s, consumers today some of whom are actively embracing high fat keto diets are more worried about sugar, acknowledged Caruso.

But theyre also worried about their weight, and they are still paying attention to calories, and given that fat contains a lot more calories per gram (9) than carbs or protein (4), it is the easiest target to drive calories out of products, he said.

The low-fat ship sailed 25 years ago, but this is not about low fat, its about caloric reduction.

And if food culture has undoubtedly changed since the technology behind EPGs was first developed three decades ago, most Americans are still consuming more calories than they are burning off, and many of them come from fat, added Caruso.

There is currently nothing like this is on the market. We have two products, a confectionery EPG with a very sharp melting curve designed to mimic cocoa butter or fractionated palm kernel oil, and our workhorse spreadable EPG, which works in all of the other applications.

As to whether EPG would be considered clean label, theres no simple answer as this is not a legally defined term, said Caruso, although he conceded that some natural and organic brands might not be interested.

However, brands that are trying to appeal to calorie-conscious consumers are particularly excited by Epogee's potential to cut calories but also eliminate ingredients such as gums, starches and binders, preservatives and flavor enhancers that are often used in low calorie or low fat foods, he said.

The road to commercialization has been lengthy for EPGs, which were first developed in the 1980s by ARCO Chemical Company, which teamed up with Bestfoods to explore their potential as fat replacers in foods.

However, Bestfoods withdrew from the joint venture shortly thereafter, and work did not resume until late 2003 when the technology was assigned to a non-profit affiliated with Kansas State University. A new partner, Choco Finesse, LLC, was later granted development rights and changed its name to Epogee.

'Not another Olestra'

Epogee is not anotherOlestra(a hybrid molecule of sucrose esterified with eight fatty acids from Procter & Gamble that attracted a wave of negative PR over its messy side effects... notably anal leakage), says founder and CTO David Rowe.

"We got to learn from their experiences and essentially avoid some things that they did but we also have better chemistry. Our product is safer in terms of things like vitamin depletion[Epogee does not inhibit the absorption of fat-soluble vitamins], but another key thing is that Epogee is made from fat and tastes like fat.

Olestra had kind of a weird mouthfeel and for people old enough to remember the potato chips, they didnt quite taste like potato chips, but French fries or donuts made with Epogee will actually beat regular French fries or donuts[on taste/mouthfeel].

What are EPGs?

EPGs are a family of fat- and oil-like substances that resemble triglycerides in structure and appearance, but have been modified to prevent or limit their digestion when consumed in food.

How is Epogee made?

*According to aGRAS noticesubmitted to the FDA in 2015, esterified propoxylated glycerol (EPG) is produced by a three-step process: First, fats and oils are split into glycerol and fatty acids. Next, glycerol is reacted with propylene oxideto produce glycerol with propyleneglycol units (PGUs) inserted on its hydroxyl groups. Finally, the propylene glycol-substituted glycerol is reacted with fatty acids to produce EPG, which largely resists digestion because the PGUs prevent the digestive enzyme lipase from breaking down the fat.

Is it safe?

The FDA has no questions regarding the GRAS status of EPG for multiple food applications including confectionery products; frying; baked goods and baking mixes; frozen desserts and mixes; nut products (including peanut butter); grain products; pasta; granola and snack bars; sauces and gravies; soft candy; snack foods (potato chips, corn-based savory snacks, chicken nuggets); plant-based protein products; dairy product analogs; beverages/beverage bases; coffee, and tea.

EPGs have been evaluated for safety at levels as high as 150 grams per day.

How is it labeled?

Epogee - the brand name for EPG (esterified propoxylated glycerol) can be listed on food labels as EPG (modified plant-based oil).

While the word modified might conjure up images of genetic engineering (which isnotinvolved in its production), Epogee has not experienced any pushback from manufacturers or consumers on the name, claimed Caruso, who noted that modified starch is a common term on food labels.

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CRISPR-Based Therapeutics Market with Report In Depth Industry Analysis on Trends, Growth, Opportunities and Forecast – Cole of Duty

Posted: at 12:45 am

The orbisresearch.com has published CRISPR-Based Therapeutics market 2020 global trends and analysis report to its store

The Global CRISPR-Based Therapeutics market report is deep study of the present market dynamics. It consists of the detailed study of current market trends along with the past statistics. The past years are considered as reference to get the predicted data for the forecasted period. Various important factors such as market trends, revenue growth patterns market shares and demand and supply are included in almost all the market research report for every industry. A significant development has been recorded by the market of CRISPR-Based Therapeutics, in past few years. It is also for it to grow further. Various important factors such as market trends, revenue growth patterns market shares and demand and supply are included in almost all the market research report for every industry. A systematized methodology is used to make a Report on the Global CRISPR-Based Therapeutics market. For the analysis of market on the terms of research strategies, these techniques are helpful. All the information about the Products, manufacturers, vendors, customers and much more is covered in research reports.

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Key Players:Caribou BiosciencesAddgeneCRISPR THERAPEUTICSMerck KGaAMirus Bio LLCEditas MedicineTakara Bio USAThermo Fisher ScientificHorizon Discovery GroupIntellia TherapeuticsGE Healthcare Dharmacon

Types:Genome EditingGenetic EngineeringgRNA Database/Gene LibrarCRISPR PlasmidHuman Stem CellsGenetically Modified Organisms/CropsCell Line Engineering

Key Applications:Biotechnology CompaniesPharmaceutical CompaniesAcademic InstitutesResearch and Development Institutes

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Gene Therapy and Editing : Novel options for inherited retinal blindness – ETHealthworld.com

Posted: at 12:45 am

(Representative image) by Dr. Indumathi MariappanResearch Scientist, LV Prasad Eye Institute, Hyderabad

Retinal Blindness

Millions of people the world over suffer visual disability as a result of retinal dystrophy that involves the death of retinal cells that are important for the light sensing function of the eye. Enormous progress has been made in other blinding conditions involving the cornea, lens, among others. However, the retinal dystrophies and optic nerve atrophies do not have any proven therapy till date. The major forms of retinal dystrophies such as Age-related macular degeneration (AMD), retinitis pigmentosa (RP), Lebers congenital amaurosis (LCA), Stargardts disease etc. are either inherited disorders or developed with aging. In most cases, the retinal cells are present at birth, but undergo gradual death during the later stages of life. It is typically characterized by initial symptoms of low vision and night blindness during early childhood, which progresses to severe visual impairment and total blindness at different stages of adulthood. Inherited defects in many genes involved in retina-specific functions and vitamin A metabolism are linked to various forms of retinal dystrophies. These genetic defects affect the normal cellular functions of the retina, leading to gradual cell death and ultimately the patient becomes legally blind.

Recent Technologies and Novel Treatment Options

The current modalities for the treatment of such patients mainly include dietary supplements, visual aids and rehabilitation support. However, a radical approach is required either to preserve or to restore visual function in these patients. Some of them include the replacement of either the lost retinal cells or the defective genes within the surviving, but non-functional retinal cells. This has been the principle behind the massive efforts involved in the development of cell and gene-based therapies. They are currently at different stages of product development and clinical trial evaluation. In cell therapy, normal retinal cells are prepared from specialized stem cells and are injected into the eye to replace the lost cells and to restore retinal functions. Clinical safety trials using cell therapy are ongoing in many countries such as USA, Japan, UK and others (Weblinks 1-4). In gene therapy, the prime strategy is to introduce a normal copy of the affected gene into the surviving retinal cells of the patient, to restore normal cellular functions and improvements in vision. This is achieved by engineering safe viral vectors to carry a normal copy of the desired gene as their cargo. When injected into the eye, the viruses can infect the retinal cells once and deliver the normal gene to restore cellular functions (Weblinks 5-7). A step further is an advanced method of DNA microsurgery, wherein, the defective part of the retinal cell DNA is precisely edited to correct the genetic defect and to restore cellular functions. This could be achieved using the latest gene editing tools such as ZFNs, TALENs, CRISPR/Cas systems etc. These are naturally occurring molecular scissors, employed as host defense mechanism and immune memory to combat viral infections in different species of bacteria. These systems are now engineered to enable DNA and RNA editing in almost any living cells. Such tools are now combined with either cell therapy or gene therapy to develop novel drugs for the treatment of various inherited genetic diseases (Weblink 8).

Gene therapy products approved for clinical use:

LUXTURNATM (Weblink 5)

This is the first commercial gene therapy drug approved by the US-FDA and European Commission for the treatment of an early childhood retinal dystrophic condition called the Leber Congenital Amaurosis 2 (LCA2). This disease is caused due to genetic defects in the gene called RPE65. LUXTURNA (AAV2-hRPE65v2 or Voretigene neparovec-rzyl) is an engineered adeno-associated virus 2 (AAV2) vector carrying a normal copy of the human RPE65 gene. This product was developed and marketed by Spark Therapeutics, a US-based startup now owned by Roche, a Swiss pharma company.

This drug has been tested on 20 patients, aged 3 years or older, in a randomized, controlled, open label, phase 3 interventional clinical trial at two sites in the US from June 2015. All treated individuals showed significantly improved functional vision, with no product-related serious adverse events or deleterious immune responses. The treated patient will be followed for further 15 years until March 2030 to assess the long-term retinal gene expression and stable maintenance of functional vision. It is administered as a onetime injection behind the retina of an eye of patients genetically diagnosed to carry mutations in RPE65 gene and also have sufficient viable retinal cells. It is priced at $850,000 for two eyes in the US and UK, which translates to about 6.5 crores in Indian rupees.

Many such gene therapy vectors are currently under clinical trial evaluation for the delivery of other retinal gene such as REP1, PDE6B, RPGR, OAT (Ornithine aminotransferase), MERTK, sFLT1etc.

EDIT101 (Weblink 8)

This is the first gene editing based drug approved by US-FDA, for the treatment of another early childhood retinal dystrophic condition called LCA10, caused by defects in the CEP290 gene. Here, it is important to understand that a gene editing approach is different from a gene therapy. In gene therapy, a normal copy of entire gene is delivered to the retina to complement the defective gene. In CRISPR/Cas9 based gene editing, only the mutated region of the gene is edited/corrected in situ inside the target cells. This is an attractive approach for correcting a variety of gene mutations, especially those in large genes which exceed the cargo capacity of the commonly used AAV-based gene therapy vectors.

EDIT101 (AGN-151587) is an engineered adeno-associated virus 5 (AAV5) vector carrying a CRISPR/Cas9 based DNA editing machinery to locate and remove a specific mutation hotspot within the intron 26 of human CEP290 gene. When injected behind the retina, the virus will infect the surviving photoreceptor cells and deliver the CRISPRs to enable mutation editing. Successful DNA edits in photoreceptor cells would inactivate a spurious splice site created by the mutation and restore normal protein expression and retinal function.

Preclinical testing in mice and monkey eyes has proved significant edit efficiency of up to 28%, which was above the expected 10% threshold required for clinical efficacy in human trials. This drug was developed by the gene editing company, Editas Medicine, Inc. and is being tested in 18 participants in a Phase 1/2 clinical trial sponsored by Allergan, at four sites in the US from March 2019 and the outcomes are awaited.

Similar gene editing strategy is being explored at different centers for mutation correction in other retinal genes such as KCNJ13, RP1, USH2A, MYO7A, RDH12 etc.

Who can benefit?

Both gene therapy and gene editing approaches have opened up newer hopes for the treatment of various genetic condition affecting different cell types of the body. However, only a small subset of patients can benefit from such therapies at the moment. Such treatment considerations require a thorough genetic screening/genotyping to confirm the identity of the gene affected in a specific patient. Further, the patients should retain some viable cells in the retina for the treatment to be clinically effective.

Research efforts in India

Many labs in the country are developing gene therapies and gene editing based therapeutics for the treatment of various diseases affecting the blood, retina, liveretc. Researchers at the CMC, Vellore, CSIR-IGIB, Delhi, CSIR-CCMB, Hyderabad are developing gene therapeutics for the treatment of different forms of blood disorders. Narayana Nethralaya, Bangalore is engaged in developing AAV-based gene therapies for various retinal dystrophies. Our lab at the LV Prasad Eye Institute is collaborating with the research teams at IIT-Kanpur and CSIR-IGIB, Delhi to develop modified gene therapy vectors for retinal gene delivery and cell-based therapies using CRISPR edited stem cells and retinal cells respectively.

The way forward

As of May 2020, the RetNet database lists about 271 genes to be associated with different forms of retinal dystrophies. This requires a larger library of gene delivery vectors to be developed and made available at affordable costs for the treatment of a large number of patients. This mandates the need for developing indigenous and cost-effective therapeutics and ICMR has set up a dedicated task force on gene therapy research, to identify and support promising research ideas in this newly emerging area of biomedical research. A national guideline for gene therapy product development and clinical trials has been jointly formulated and released by the DBT and ICMR in 2019. It is hoped that the streamlined regulatory framework would fast track our basic and translational research efforts into developing novel and cost-effective treatment options in the near future.

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Fat cells remember their diets early in life – Massive Science

Posted: at 12:45 am

Our relationship to Neanderthals has been a point of contention for over a century. It all began with an inaccurate reconstruction of the first Neanderthal ever found, which portrayed them as brutish, stooped-over cavemen (turns out, that Neanderthal was an injured old man with arthritis).

But within the last half century, scientists have noticed the many biological and behavioral similarities that show just how close our species are. While these similarities are clear from hard objects like bones and tools, perishable objects, which comprise the majority of material culture items in humans, have been lacking.

Now, scientists have discovered a Neanderthal feat that hammers another nail in the coffin of supposed Neanderthal inferiority. Last month, an international team of researchers found a small section of a twisted cord attached to a stone flake in Neanderthal site in southeastern France, dated to over 40,000 years old. This constitutes the oldest direct evidence of fiber technology ever found.

A stone flake with three distinct twisted fibers preserved (indicated by the box).

M.-H. Moncel

When artifacts are recovered from archaeological sites, they are generally imaged using high powered microscopes to zoom in on tiny marks and details on the stones. Previously, plant fibers had been found on stones at this site, but they were too poorly preserved to be interpreted. When the team examined this particular flake, they were surprised to find three distinct twisted fibers, which were then twisted together in the opposite direction to form a 3-ply cord.

While it may not sound like much, this piece of string hints at something much more significant. For one, extracting and manipulating plant fibers requires working memory, as well as understanding plant seasonality and the concept of numbers. Also, such cords are the building blocks for creating other textiles, such as baskets, fabrics, and nets. Once adopted, these objects would have been indispensable in daily life.

This little piece of string provides unprecedented insight into the lives of our extinct relatives, which, despite an abundance of genetic, archaeological, and skeletal data, have been extremely difficult to interpret. It seems as though we humans arent as unique as we like to think.

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Ethicists: We need more flexible tools for evaluating gene-edited food – The Conversation US

Posted: May 29, 2020 at 12:52 am

Is there now a way to genetically engineer crops to create food that people can confidently consider natural?

Gene-editing technology sounds like it might offer this possibility. By altering an organisms genetic material, or genome, without introducing genes from other species, advocates of genome editing argue the technique can sidestep most of the difficult ethical and regulatory challenges plaguing organisms with added transgenes, which are genes from other species. Some even argue these cisgenic products are natural enough to count as organic.

As ethicists specializing in how technology alters human-nature relations, we can understand why advocates see the ethics this way. If crossing species lines is the measure of whether a technique counts as natural or not, then genome editing appears to have the potential to pass a naturalness test.

Genome editing, its boosters say, can make changes that look almost evolutionary. Arguably, these changes could have happened by themselves through the natural course of events, if anyone had the patience to wait for them. Conventional breeding for potatoes resistant to late blight is theoretically possible, for example, but it would take a lot of time.

Although we understand the potential advantages of speed, we dont think an ethics hinging on the idea of cisgenesis is adequate. We propose a better ethical lens to use in its place.

Our work is part of a four-year projectfunded by the Norwegian Research Council scrutinizing how gene editing could change how we think about food. The work brings together researchers from universities and scientific institutes in Norway, the U.K. and the U.S. to compare a range of techniques for producing useful new crops.

Our project is not focused on the safety of the crops under development, something that obviously requires concerted scientific investigation of its own. Although the safety of humans and the health of the environment is ethically crucial when developing new foods, other ethical issues must also be considered.

To see this, consider how objections against genetically modified organisms go far beyond safety. Ethical issues around food sovereignty range broadly across farmer choice, excess corporate power, economic security and other concerns. Ethical acceptability requires a much higher bar than safety alone.

Although we believe gene editing may have promise for addressing the agricultural challenges caused by rising global populations, climate change and the overuse of chemical pesticides, we dont think an ethical analysis based entirely on crossing species lines and naturalness is adequate.

It is already clear that arguing gene-edited food is ethical based on species lines has not satisfied all of gene editings critics. As Ricarda Steinbrecher, a molecular biologist cautious about gene editing, has said, Whether or not the DNA sequences come from closely related species is irrelevant, the process of genetic engineering is the same, involving the same risks and unpredictabilities, as with transgenesis.

Comments of this kind suggest talking about species lines is an unreliable guide. Species and subspecies boundaries are notoriously infirm. Charles Darwin himself conceded in Origin of Species, I look at the term species, as one arbitrarily given for the sake of convenience to a set of individuals closely resembling each other.

The 2005 edition of the Mammal Species of the World demonstrated this arbitrariness by collapsing all 12 subspecies of American cougars down to one Puma concolor cougar overnight. In 2017, the Cat Classification Task Force revised the Felidae family again.

If species lines are not clear, claiming naturalness based on not crossing species lines is, in our view, a shaky guide. The lack of clarity matters because a premature ethical green light could mean a premature regulatory green light, with broad implications for both agricultural producers and consumers.

We think a more reliable ethical measure is to ask about how a technique for crop breeding interferes with the integrity of the organism being altered.

The term integrity already has application in environmental ethics, ecology, cell biology, interhuman ethics, organic agriculture and genetics.

A unifying theme in all these domains is that integrity points toward some kind of functional wholeness of an organism, a cell, a genome or an ecological system. The idea of maintaining integrity tracks a central intuition about being cautious before interfering too much with living systems and their components.

The integrity lens makes it clear why the ethics of gene editing may not be radically different from the ethics of genetic modification using transgenes. The cell wall is still penetrated by the gene-editing components. The genome of the organism is cut at a site chosen by the scientist, and a repair is initiated which (it is hoped) will result in a desired change to the organism. When it comes to the techniques involved with gene editing a crop or other food for a desired trait, integrity is compromised at several levels and none has anything to do with crossing species lines. The integrity lens makes it clear the ethics is not resolved by debating naturalness or species boundaries.

Negotiation of each others integrity is a necessary part of human-to-human relations. Adopted as an ethical practice in the field of biotechnology, it might provide a better guide in attempts to accommodate different ethical, ecological and cultural priorities in policymaking. An ethic with a central place for discussion of integrity promises a framework that is both more flexible and discerning.

As new breeding techniques create new ethical debates over food, we think the ethical toolbox needs updating. Talking about crossing species lines simply isnt enough. If Darwin had known about gene editing, we think he would have agreed.

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