Category Archives: Genetic Engineering

Before Sam Sternberg was part of the scientific breakthrough of the century, he was one of the winners of Lancaster Countys science and engineering fair.

CRISPR can be explained as a find-and-replace tool, Sternberg said in a Common Hour talk at Frankin & Marshall College last year. It can find misspelled sequences of DNA that cause genetic mutations and replace them with the right sequences.

Sternberg did his doctoral research in a laboratory at the University of California, Berkeley, where Doudna made this important discovery. Since then, researchers have been fighting in court over the patent for genetic engineering with CRISPR.

After Sternberg finished his graduate work, he focused on co-writing the book about the CRISPRs discovery to bring the story to an audience beyond the science community.

Doudnas memoir is partly an attempt to sustain her voice in the debate over Crisprs practical and less-practical uses and partly an effort to secure her legacy, Bloomberg writes.

Some reviewers say they would have liked more discussion on the ethics of genetic engineering, especially on genes that are inheritable.

Doudna and Sternberg predict that within a generation there will be little left untouched by CRISPR, says a review from Science." As such, its impossible not to wonder if the motivation behind the book is to stake Doudnas claims on the technology or if, perhaps, it is meant to serve as a preemptive mea culpa for unleashing a technology that will irrevocably alter life on Earth.

There are many compelling reasons for why this is a worthy contribution for any booklist, but for Berkeley the justification is even richer. UC Berkeley has been ground zero for this entire technology, with contributions from others around the world. Secondly, the ramifications of this technology are so widespread that only a campus with broad excellence in all areas is adequate to engage the range of implications that this technology offers. UC Berkeley Library

Though the authors note that science involves both competition and collaboration, they avoid discussion of the myriad conflicts that exist in this exciting new fieldan absence that makes the rosy picture presented in this otherwise excellent book just a bit too unbelievable. Publishers Weekly

The larger purpose of A Crack in Creation, clearly, is to show that Doudna is the true hero of CRISPR. And ultimately, despite the book's flaws, I'm convinced. Nominators and the Nobel Committee will need to read this book. But CRISPR binge-watchers like me still await a truly satisfying account one that is insightful, candid and contextualized. Nature

Read more here:
McCaskey grad writes new book on CRISPR and genome engineering - LancasterOnline

On July 12, a Food and Drug Administration panel unanimously recommended approval for the first-ever gene therapy treatment for cancer. The treatment, known as CTL019, is a T-cell therapy developed by the pharmaceutical company Novartis. It is tailored for each individual patient and has already been proven effective for treating a type of childhood leukemia. The New York Times reports that in a study of 63 patients, 52 of them went into remission after receiving the treatment.

Researchers have long been working to perfect gene therapy for a variety of cancers, but CTL019 will be the first to reach the market. If the FDA moves to approve CTL019, the decision could open the door for more gene therapy treatments for other diseases.

Mansoor Amiji is University Distinguished Professor inthe Department of Pharmaceutical Sciences at Northeastern. His research focuses on the development of targeted therapies, including gene therapy, for treatment of the most lethal cancers, such as pancreatic, lung, ovarian, and brain tumors, as well as other chronic diseases. For one project, Amijis lab is interested in reprograming immune cells through genetic engineering to become more effective in treating cancer and inflammatory diseases.

Here, Amiji explains more about gene therapy treatment and why the approval of CTL019 would be so significant.

It is still very early to suggest that cancer immunotherapy will lead to the ultimate cure or even long-term control of cancer, says distinguished professor Mansoor Amiji. But the opportunity to use the bodys own defenses to eradicate cancer cells is truly groundbreaking. Photo by Adam Glanzman/Northeastern University

CAR-T cell, or chimeric antigen receptor T-cell therapy, is one of the newer treatment options for cancer. Its based on the patients own immune system. In this approach, the patients T-cells are harvested and then genetically modified outside the body to produce engineered cells. The cells are then re-administered and can destroy the tumor. There have been studies conducted at various medical centers over the past several years, but this is the first time that the FDA committee is allowing a commercial pharmaceutical company to continue with the program, in this case for treatment of pediatric acute lymphoblastic leukemia.

Yes, cancer immunotherapy treatments, including CAR-T cell therapy, have been very successful in cancer treatment. More than 85 percent of patients treated with genetically engineered CAR-T cells are under remission, and that is unprecedented for cancer treatment options. However, it is still very early to suggest that cancer immunotherapy will lead to the ultimate cure or even long-term control of cancer and change it from a death sentence to a treatable chronic disease. But the opportunity to use the bodys own defenses to eradicate cancer cells is truly groundbreaking.

Genetic engineering focuses on using modified cells as drugs. In this approach, the cells are either removed from the body and genetically manipulated outside, such as in CAR-T cell therapy, or genetic constructs are delivered into specific cells in the body. For the latter, the genetic construct has to be packaged in a delivery vehiclenanoparticles, for exampleand be targeted to the right cell in the body. Conventional drugs work by inhibiting a specific molecular target, like a receptor on a cell or an enzyme involved in disease progression. Genetic therapies like CAR-T cell therapy are focused more on the treatment at the DNA or RNA level where the original defects reside. Thats why they can be significantly more effective than conventional therapies, and they also promise to be a lot safer.

The drug development process starts from preclinical discovery and then moves into the clinical phase where patients are treated with experimental methods. Typically, it takes about 10 to 15 years for a drug to go from early discovery up to the approval stage. However, there are exceptions when compelling early-stage clinical results are obtained that encourage the FDA to approve the treatment a lot faster. Also, once a trail-blazing concept like CAR-T cell therapy is approved, there are many other companies that are following behind with their own version of the treatment. Their products will be coming to the marketplace soon as well.

Read more from the original source:
What makes cancer gene therapy so groundbreaking? - News@Northeastern

'Background on the National Biotechnology and Biosafety Bill'

Prof. Morris Ogenga-Latigo

1. Introduction

The National Biotechnology and Biosafety Bill 2012 is now before the 10th Parliament for consideration and enactment. This is a highly technical Bill that for long has endured relentless highly emotive campaigns against Biotechnology and Genetically Modified Organisms (GMOs).

To enable Members appreciate the context, purpose and content of the Bill, and debate and enact the law on the basis of clarity and objective information, I have prepared this scientific background information that frames and contextualizes the Bill.

I have done this not because some foreign entity is paying me to enact the law as some claim about MPs. HELL NO! Those who know Prof. Latigo well know that this can never be the case. I am doing this because this Bill is necessitated by the needs of our country that we as Parliamentarians are obligated under the Constitution to address by enacting appropriate laws.

More importantly, I saw the potential of Molecular Biology as long ago as the late-1980s when I was winding up my Ph.D. studies at the International Centre for Insect Physiology and Ecology (ICIPE), Nairobi. In 1996, as an Academic in Makerere University, I became the Focal Point on Biotechnology and a Founding Member of the National Biosafety Committee of the National Council for Science and Technology. I served the Council for 10 years (part of it when I was an MP in the 7th Parliament), and only resigned in 2006 when I became the Leader of Opposition.

In the 10 years, we supported Biotechnology capacity development for Uganda through graduate training and supporting establishment of dedicated Biotech Laboratories. With progress, we developed the National Biotechnology Policy and early drafts of the National Biotechnology and Biosafety Bill.

I am therefore deeply obligated to the country to inform and enlighten Members, and to do whatever I can to ensure that this Bill is passed into law to serve the best interest of our Country, our farmers, and agriculture that I love and am so deeply involved in.

In doing so, I act as a patriotic Ugandan of known academic, research and political leadership trek record and deep conviction, and one keen to share his little knowledge on crop improvement, Biotechnology and GMOs with colleagues, and never because of having been remotely corrupted or bribed by anybody.

My specific views on the Bill, on the Main and Minority Reports from the Committee, and on the proposed amendments of the various clauses of the Bill will be shared with you during the Second and Third Readings of the Bill. Below is a presentation on the genesis of the Bill.

2. Genetic Engineering, Biotechnology and the March of Science

Biotechnology is an applied science that derives from the core field of Biology, and the core subject of Genetics, both of which have developed over time and in complexity, and have become highly specialized and sometimes difficult to appreciate in the context of our cultures, religious beliefs, and our day to day life experiences.

From being the study of living organisms in their wholesome, Biology has now developed to the molecular level, hence the field of Molecular Biology. Similarly, from the study of inheritance and inherited physical variations in organisms, Genetics has moved to the levels of chromosomes, DNAs, genes, RNAs etc. and their manipulation, and out of which progress has emerged the science of Genomics.

Biotechnology applies these advanced knowledge and capabilities to generate modified life forms and their products in ways that transcend the ordinary boundaries of nature and the ordinary limits of natural processes.

Thus, in agriculture, whereas traditional Biology talks about species barriers in the inability to share genes amongst organisms that do not interbreed, Biotechnology allows us to move desired genes from one species to another regardless of natures sexual barriers. This has enabled us to exploit genes that exist in nature, and created by God as the building blocks of life, without the limits inherent in traditional methods of crop improvement.

Beyond Biotechnology, the science of Synthetic Biology and its applied field of Bio-hacking are also now emerging where, rather than genetically modifying crops or animals to do the things we want, we now use knowledge to imitate nature. Thus, amazingly, we are now able to produce milk without cows or beef without cattle.

3. Progress in Crop Improvement and the Imperative of Biotechnology

In the beginning, man relied on natural gene changes (mutations) to generate plant variations and diversity that he exploited by chance and choice, and refinement through repeated selection. With the advent of Genetics, we were able to deliberately cross plants of the same species to create variants and to then select for use those plants with attributes we most desired. This was the advent of conventional breeding.

More recently, rather than waiting for nature to modify genes and create plant variants for us to select from, radioactivity allowed us to imitate this natural gene change process. Using radioactive substances, we have been able to deliberately induce gene changes (mutations) and to then select mutant plants that best suit our needs that we then cross with other desired plants of the same crop in conventional breeding processes. This approach to crop improvement became known as Mutation Breeding.

Building on these sexual reproduction approaches to develop new crop types, the study of genetics later showed us that when you crossed plants of the same species from two lines of a crop that have distinct and stable attributes, their off-springs were more vigorous and had positive attributes greater than the additive value of the attributes of the two parent lines. This was the phenomenon of hybrid vigour, also seen in our half-caste children being physically much more vigorous in growth, size and activity than their two parents.

Breeders then began to develop pure crop lines of maize etc. that, when crossed, produced hybrids with superior performances. So emerged hybridization as a crop breeding technique the products of which are the hybrid crop varieties that yield far more than varieties developed using conventional breeding.

Hybridization and hybrid vigour have so far capped plant performance improvements. Nevertheless, hybrid breeding has been improved beyond the two pure line crosses. Now, we enhance performances and plant characteristics through double or multiline hybridization where two pure lines are crossed and the products of their crosses are further crossed to produce double or multi-line hybrids.

In all the above crop improvement approaches, there is always one natural barrier to the sharing of genes between different crops to produce desirable characteristics. In nature, a desirable gene in species A cannot be moved to species B because of the species barrier rule that says that one crop species cannot breed with another crop species.

Thus, whereas one maize type can cross with another maize type, maize will never cross with cotton. If a cotton line is resistant to a plant disease X, therefore, using conventional breeding, the cotton can be crossed with another cotton line that has good characteristics but is attacked by disease X. Through repeated crossing and screening, a cotton line will eventually be developed that will possess both the good characteristics and resistance to disease X. This then becomes the new disease resistant cotton variety.

Even when the disease X attacks both cotton and maize, as often happens, however, the resistance to disease X identified in cotton cannot be transferred to maize through conventional breeding because of the cross-species reproductive barrier.

In the quest to break this species barrier so that the disease resistance in cotton can be shared with maize and other crops, scientists developed techniques for transferring desirable genes across species using their understanding of molecular biology, genomics, and biochemistry. The techniques so developed became known as Genetic Engineering, and the science that encompasses the whole process became known as Biotechnology.

4. Enter Monsanto and GMO crops

Monsanto was the company that developed the herbicide glyphosate, which in the sixties and seventies was marketed in Uganda as Roundup and was extensively used to control weeds in coffee and banana fields. In the various advocacies against Biotechnology and GMOs, this company and its products are the demons used to scare us off.

Glyphosate is a general purpose insecticide that is basically less poisonous to man than a strong drink of caffeine of coffee. It is not a poison to us because we do not have cell receptors on which it must attach in order to react with and kill our body cells. Thus, when we swallow or absorb glyphosate, our kidneys merely filter it out and is mostly excreted unchanged in urine.

In weeds, however, glyphosate is absorbed by leaves and transported to roots. There, it binds with a single enzyme and disrupts root metabolism. The root then dies stopping the plant from taking up water and nutrients, and the plant is gradually starved to death. This explains why when we apply glyphosate today weeds remain green for days before turning yellow and only drying up after 2-3 weeks.

As glyphosate became widely used, it was noticed that certain plants did not die even when the glyphosate dose used was high. Monsanto scientists, in studying this phenomenon to overcome the limitations of their product, identified these plants as having ability to break down glyphosate and render it harmless to the resistant plants.

From their study to understand why their herbicide did not work, the Monsanto scientists saw an opportunity of transferring this herbicide resistance attribute from weeds to crop plants, such that now plants with the resistance attribute can be grown with weeds and glyphosate is then used to eliminate the weeds but will not kill the modified crops.

Monsanto identified and isolated the gene that was responsible for producing the enzyme that broke down glyphosate once it was sprayed on the resistant weed and introduced it in crop plants (maize, soybean). To protect its commercial interest, Monsanto patented the gene and the process of its transfer into crops.

Using genetic engineering, they transferred this gene into maize, and later soybean, and developed their own commercial GMO maize and soybean varieties that could be grown with weeds but that would not be killed when glyphosate is applied to kill weeds growing with them. This is the genesis of the controversies about GMOs, Monsanto, and the supposed dominance of Biotechnology, genetic engineering and seed supply by multinational corporations.

Because of the gene patent restriction secured by Monsanto, the only option left to fight Monsanto was to demonize Biotechnology, the products of genetic engineering, and the companys GMO crop varieties. Hence the claims of: the evil of foreign genes, the carcinogenicity of glyphosate or Monsantos GMO maize, the sinister plans of multinationals to deprive us of our indigenous seeds and food sources etc. The truth however is far from this.

5. The Controversies Surrounding Biotechnology and GMOs

There have been numerous attempts to scare us off Biotechnology and its GMO crops and products, through arousing uncertainty and deep fear of the unknown. The scare-mongering is, however, essentially unjustified and is absolutely unjustifiable in science, facts and realities.

Firstly, there is no gene that is foreign. The mould for the bricks used to construct all living things is the gene. The traits of a human being, for example, are based on the expression of approximately 80,000 genes packaged in structures called DNAs. The genes that are inherited from our parents contain all the biological instructions (moulds for making the bricks) for building a human being.

Just as each unique brick mould will produce a unique brick, every gene in the DNA codes (instructs) the making of only one unique protein (enzyme) needed in our biological processes. Whether that brick is used to build a latrine, a residential house etc. does not matter because, wherever it is, the brick will do precisely what it is supposed to do only, and can never become cement or paint.

Similarly, a gene will encode for only that one protein required to fulfill a particular function in the building of a living organism, be it a bacterium, maize, banana or us humans, and we share many such genes. In fact, around 96% of the genes in us humans are shared with chimpanzees and mice, and we humans share approximately 99% of our DNA with other humans, 98% with chimps, 70% with slugs and 50% with bananas.

So where does the distinction and the fear of foreign genes or DNAs and their harmful effects when a gene from another source is inserted into a crop come from, particularly when the genes involved in GMO crops are even from other plants?

If that one gene that codes only the making of that one enzyme that breaks down glyphosate and nothing else is inserted into a maize variety so that the maize becomes resistant to glyphosate, where do the claims of harmfulness or risks of it causing cancer then come from? So what is the fear of Biotechnology and GMOs based on, and why the extreme caution about GMOs?

Secondly, whether in conventional breeding, mutation breeding, hybridization, genetic engineering or even human reproduction, new characters are only produced because the original genetic compositions of the source parents have been modified. In other words, every life form that is different in character and other attributes from any of the parents, as we all are different, is essentially and truthfully a genetically modified organism or GMO.

The only difference now is that crops modified through the process of genetic engineering or Biotechnology are called GMOs, and are feared and demonized, whereas all the other crops that are also genetically modified using conventional breeding methods, are now called non-GMOs, are not feared or demonized, and are easily accepted.

Thirdly, we can never take control of Biotechnology and use it to define our future and utilize it to address our challenges and fulfill our needs unless we build our internal capacities and take charge of the science and the opportunities it offers us, our competitors and the world.

China did not counter the threats and dominance of nuclear USA or Russia by propagating the fear of Nuclear Science. Instead they built their capacities in Nuclear Science and relevant technologies, and ability to exploit the potentials embedded in the science. And now they are part of the worlds Nuclear Powers, with the USA and Russia, and respected by the two countries.

Fourthly, as Ugandans, the threat to our key crops, Coffee and Bananas, by the emergence of new diseases (bacterial wilt etc.) offers us the best opportunity to appreciate the value of Biotechnology and genetic engineering to the security of our country and people.

Bacterial wilts have devastated our coffee and banana crops because the varieties we grow do not possess resistance to these diseases. For coffee, if we are to develop new resistant varieties through conventional breeding, it means we have to first identify coffee plants resistant to the wilt, and grow them and cross them with our commercial varieties. We then have to test thousands of their off-springs to identify plants with resistance to the wilt, and also grow the resistant plants to determine whether they have the same commercial attributes of our susceptible varieties.

Where the identified resistant lines do not meet our standards, we have to undertake repeated backcrossing with the susceptible parent and repeated selection until we get the desirable varieties resistant to the disease for release to farmers.

Since the maturity period for coffee is at least 4-6 years, this conventional breeding approach will require 20-30 years for us to develop new coffee varieties resistant to the wilt. In these 20-30 years, what would happen to our coffee industry, to the livelihoods of our farmers, and to the economy of our country?

The challenge is even worst for our bananas that do not reproduce sexually, and are only propagated vegetatively. Thus, even if we identify a local banana line resistant to bacterial wilt, it is not possible to transfer that resistance to the other susceptible banana varieties through conventional breeding because our bananas do not breed or cross in nature sexually.

Thus, for our bananas and coffee, that multinationals have little interested in, our only means to protecting them against emerging diseases, pests and the challenges of climate change, or to quickly improving them to meet our needs, is to develop our national capacity to identify sources of resistance and other desirable genes and to be able to quickly move these genes within the pool of our coffee and banana varieties through Biotechnology and genetic engineering.

If we reject Biotechnology because some people have demonized it and GMOs, what options do we have for our country?

6. Final Appeal

Here in Uganda, since the late-1990s, we recognized the potential of Biotechnology and embarked on building our capacities (human resources and labs) to exploit this potential for rapid crop varietal development in light of emerging new diseases and pests, the effects of climate change and drought, and the need to produce enough food of the right qualities to meet our needs now made urgent by our rapid population growth.

Consequently, we have built a large body of highly competent and internationally recognized scientists who are working diligently, honestly and selflessly in our ultramodern Biotechnology Laboratories at Makerere University, Kawanda, Namulonge etc., but who are being held back by the absence of a legal regime to enable them work without fear of potential undefined liabilities.

The operational framework to enable our scientists engage in Biotechnology capacity development and its exploitation, in conformity with international standards and protocols, is this National Biotechnology and Biosafety Bill that meets the international standards set out in the Convention on Biodiversity (CBD) and the Cartagena Protocol on Biosafety (CPB).

The National Biotechnology and Biosafety Bill 2012, now before Parliament, is a draft law formulated by us as a country to enable us safely develop our Biotechnology capabilities in order to secure our future and wean and protect us from potential dependence on, and bondage of, multinational interests.

This aspiration will never be achieved: When we are driven to legislate out of propaganda and fear, and out of unfounded suspicion that the Bill that was developed and introduced by the Government of the ruling NRM Party is actually a Bill pushed by multinationals to meet their selfish interests. When our scientists, whom we invested in and are working in the field of Biotechnology, are demonized, maligned and presented in bad light, and their voices ignored, and when the falsehoods propagated by CSOs and some non-Biotech scientists about the dangers of Biotechnology and GMOs are instead believed and are the basis of our legislative drive. And when our individual biases- religious, political, ideological etc.- take precedence over our obligation to legislate in the best interest of our country.

Against the above, I make a passionate appeal to us all, Members of the 10th Parliament, individually and collectively, to accept the facts of Biotechnology and our National aspirations to exploit its potentials as the sole basis for inputting into the process of considering the National Biotechnology and Biosafety Bill 2012 now before us, and to trust in the expert advice that our scientists and some of us, your colleagues, are able to offer to the August House.

Please let us take our obligation to act as Patriots and to legislate non-emotively, and in the best interest of our country and people, most seriously.

The writer is the MP for Agago North, Member of the Pan African Parliament and the former Leader of Opposition in 8th Parliament. He is also the former member of the Uganda National Biosafety Committee (1996-2006)

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Background on biotechnology Bill - New Vision

University of Canberra scientists failed to comply with genetic engineering safety protocols while researching a mosquito-borne virus linked to brain damage.

It is one of dozens of compliance incidents involving genetically modified viruses, bacteria and crops that have occurred across Australia since 2011.

Fairfax Mediacan reveal 32 separate incidents of non-compliance committed by universities, government laboratories and large agricultural companies, including:

The risks associated with all 32 incidents reported have been assessed as "negligible" by the federal Office of the Gene Technology Regulator.

Many were minor incidents caused by administrative oversights.

The incidents have been described in reports published by the regulator as well as documents obtained by Fairfax Media under Freedom of Information laws.

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In 2015 the University of Canberra contravened GMO licence conditions during an experiment with the Murray Valley encephalitis virus, a mosquito-borne virus that can cause brain damage.

Scientists were attempting to create a new vaccine by engineering the virus with two genes from the virus that causes Dengue fever.

"At the time of the inspection the University of Canberra notified inspectors that dealings with GMOs had been undertaken in a facility that had not been authorised by the licence," a government inspection report read.

"The University of Canberra did not obtain signed statements from all persons, prior to their commencing dealings, indicating that they understood and agreed to be bound by licence conditions."

A spokeswoman for the university said the breach had been an "administrative oversight" that had been quickly corrected.

"Due to storage space issues in the licensed lab, some GMO material was stored in another certified lab which was appropriate for the material but not under the licence.

"The GMO material was only stored in this certified lab and no research on it was conducted in that location."

Last year agricultural giant Bayer Crop Science was moving planting equipment from a trial site in country NSW when a small batch of GM cotton seeds were spilled.

A report of the incident showed the seeds could have been spilled over a 29 kilometre patch of road in Moree, including the busy Newell Highway.

The seeds had been modified with genes linked to insect or herbicide resistance, although the regulator concluded it was "unlikely" any plants would have grown.

A spokesman for Bayer said the government had been alerted to the incident straight away and all possible risks had been addressed.

"Bayer worked proactively with the OGTR to ensure the risks, however negligible, were addressed and remedied, including monitoring for any [plants] that might come up subsequently."

The Nuseed agri-tech company was involved in an incident in 2016, in which sheep were mistakenly allowed to graze in a paddock containing GM canola in Colac Otway, Victoria.

"Nuseed self-reported the unintentional grazing of sheep on this site," an inspection report found.

"A small number of sheep were able to access the planting area due to an unplanned drop in water levels in a dam which had previously acted as a natural barrier."

Regulators concluded the incident posed a "negligible" risk to the environment.

Nuseed declined to comment when approached by Fairfax.

In 2016 there was a non-compliance incident at the University of South Australia in which material was taken out of a facility without labelling to indicate it contained GM material.

"Persons conducting dealings with the GMO who are not fully trained in licence conditions are at risk if exposed to the GM organism," a government report concluded.

"There is no evidence, however, to suggest this issue has resulted in any harm to human health and safety at this stage."

Simon Terry is a former investment banker now running New Zealand's Sustainability Council advocacy group.

Mr Terry said the risks of genetically modified material entering the environment were more likely to be economic, rather than linked to health or safety.

"Food markets in wealthier countries are very sensitive to GMO content," he said.

"Markets for premium foods simply reject products that contain any detectable level of GMO contamination and whole countries, such as France, operate this way.

"Food producers are especially at risk from GMO varieties that have not been legally approved in the country the exports are going to.

"It is common for countries to test for GMOs at the border and if a GMO that has not been approved is discovered, the entire shipment is rejected."

Australia is currently undertaking a "technical review" of its federal gene technology regulations, with a view to ensuring they reflect technological and scientific advancements.

A spokeswoman for the Office of the Gene Technology Regulator said none of the 32 incidents of non-compliance reported since 2011 represented a failure of the current regime.

"Australia's regulatory system is considered world leading with a science and risk based approach that is timely and predictable, providing a clear regulatory pathway for the industry to follow," she said.

"The OGTR continues to work closely with our major trading partners to ensure its regulatory practices remain current and relevant and reflects international practice in relation to the regulation of GMOs."

Read the original here:
32 genetic engineering incidents since 2011 revealed in regulator's ... - The Canberra Times

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The Senate passed a bill recently that would require most foods containing genetically engineered ingredients to be identified as such. It was just a few days after Vermont became the first state to require written labels on foods known as GMOs.

The Senate bill and the related House bill may move Americans closer to what they have said they want: more transparency about how the genes of foods they are about to eat have been manipulated. But dispelling confusion over so-called genetically modified organisms may be impossible for any labeling scheme. As lawmakers hash out the details, here are some popular misconceptions.

The new labels will make clear what has been genetically engineered.

Actually: Consumers may need to scan a package to see whether something in it was genetically modified, but even then they are unlikely to learn which traits were altered and why.

At the most basic level, a GMO is a plant or animal whose DNA was directly altered in a laboratory, often by inserting genes from a distant species into its cells with the help of a bacterium or one of several other tools. Many major food manufacturers are loathe to put the words genetic engineering on labels for fear they will convey an impression that the foods are suspect. Under the proposal in Congress, manufacturers could instead label packages with a symbol denoting genetically engineered ingredients, or a quick response (QR) code that people with smartphones could scan to retrieve the information.

But manufacturers would not be required to provide information on how a food was modified or why. That a certain Hawaiian papaya, for instance, was inoculated against a virus that threatened to destroy the crop with the insertion of a gene from that virus would be impossible to tell from a generic label indicating that it had been produced with genetic engineering. You also wouldnt know, say, that the soy lecithin in your ice cream was made from soybeans endowed with a bacterial gene that lets them thrive even when sprayed with a widely used weed-killer.

GMO-free oats are better than the alternative.

Actually: There is no alternative. Stores do not sell genetically modified oats because they dont exist.

A non-GMO label, for example, has been added to the iconic white and gold aluminum cans of McCanns Irish Steel Cut Oatmeal, which is among the tens of thousands of products certified in recent years by the Non-GMO Project. But nothing has changed about the oats inside. Some flavored oatmeals may have been made with genetically modified ingredients. But as with the proliferation of fat-free or gluten-free labels on products (like water) that never had either, the GMO-free label does not mean a genetically engineered version of the same product is available.

GMO labels highlight a documented health risk.

Actually: These are not warning labels. The scientific consensus is that genetically engineered crops are as safe to eat as any other crop.

In a 2014 Pew Research Center survey, just 37 percent of American adults believed genetically modified foods were safe to eat. Yet this spring the National Academies of Sciences, Engineering and Medicine reported finding no differences that would implicate a higher risk to human health from GMO crops. There was no evidence that GMOs in North America, where they have been part of the diet since 1996, had contributed to a higher incidence of cancer, obesity, diabetes, kidney disease, autism, celiac disease or food allergies, in comparison with Western Europe, where GMOs are rarely eaten.

Several other regulatory, scientific and health organizations have also concluded GMOs are safe to eat. And the Food and Drug Administration warned last fall it would consider a label false or misleading if it implied that a food was safer, more nutritious or otherwise has different attributes than comparable foods because it was not genetically engineered.

That doesnt mean its impossible to engineer a plant or animal that would be bad for you. It has been done at least once, with a soybean that was not released for commercial use because its allergenic property was discovered in a routine screening.

The risks of every genetically engineered crop, the 420-page National Academies report emphasized, should be evaluated individually.

White strawberries have been altered.

Actually: Nope, they were created through old-fashioned crossbreeding.

Every week or so I see a tweet about GMO strawberries, said Karl Haro von Mogel, a co-founder of Biology Fortified, a nonprofit website that publishes articles about genetic engineering. About 40 percent of respondents in a 2013 New York Times/CBS poll of American adults said they thought most or a lot of fresh fruits and vegetables were genetically engineered.

But except for a few fruits and vegetables, our produce is generated through older breeding methods that do not fall under government regulations governing genetically engineered crops, and would not need to be labeled.

Japanese geneticists made seedless watermelons in the 1930s, for instance, by exposing watermelon seeds to chemicals that doubled their usual pair of chromosomes, and crossing those with pollen from a regular watermelon. It is because their offspring had an odd number of chromosomes that they could not make seeds of their own, not the result of any foreign DNA.

And the popular red grapefruit now grown in Texas is the descendant of one of thousands of mutants produced by a breeder in the mid-1960s by bombarding pink grapefruit tree buds with radiation, a technique for accelerating evolution that has yielded new varieties in dozens of crops, including barley and rice. The crops created through that method, called mutagenesis or radiation breeding, can be certified organic.

And if genetic mutation sounds scary, its worth remembering that genetic mutations happen constantly in nature without any human intervention. Orange carrots, for instance, arose from a natural mutation and became prevalent only because humans planted them. Those purple and yellow ones you might peg as GMOs were the originals. As for those white pineberries, breeders crossed two species of strawberry to create a hybrid with some of the characteristics of both combining the genetic diversity that exists in both species.

GMO wheat may be responsible for gluten sensitivity.

Actually: GMO wheat is not sold to the public.

The internet is full of blog posts and Twitter posts blaming GMO wheat for gluten sensitivity. The fundamental hole in this case is that GMO wheat is not sold to the public.

To be clear, wheat has been genetically modified. Monsanto Co. has field-tested wheat that was altered to tolerate the herbicide glyphosate. A British research institute field-tested modified wheat to repel insects. (It didnt work.) In 2014, Chinese researchers modified wheat to resist a destructive disease called powdery mildew, but just to see if they could. And Spanish researchers are testing wheat engineered to contain, yes, significantly less gluten. But none of it is on store shelves.

Humans have been making GMOs for millenniums.

Actually: While selective breeding is a form of genetic modification, GMO refers to foods made with specific forms of modern biotechnology.

Proponents of genetic engineering in agriculture like to point out that people have been genetically modifying organisms for millenniums through selective breeding and other techniques. If you look at it that way, they say, nearly everything we eat is a GMO. But a majority of Americans have consistently said in polls that they would like labels on GMOs, apparently believing a distinction between a product of traditional breeding methods and one produced through modern molecular biology should be made. Both the Vermont labeling law and the proposed national one define a GMO not as any crop in which the genetic material has changed over time, but as a crop that has been altered using specific forms of biotechnology that allow for the transfer of genetic material from one species to another or the insertion of synthetic or heavily modified DNA into an organisms genetic code. This genetic engineering has been possible for only about three decades.

If scientists change a mushrooms DNA in a lab, it would be labeled as a GMO.

Actually: If no DNA from another organism is added, then it may not count as genetically modified under the new labels.

If youve ever held a typical white-button mushroom in one hand while slicing it with the other, you know it takes only the faintest pressure to produce a brown mark.

But Yinong Yang, a plant pathologist at Pennsylvania State University, has engineered one that resists browning. Using a new technique, he simply deleted a bit of DNA that was already there, leaving no added DNA from another species. The Department of Agriculture told him earlier this month that it could be sold without regulatory oversight, and its not clear whether such products would be labeled.

GMO rice saves the lives of malnourished children in the developing world.

Actually: The rice is still being tested.

Some proponents of genetic engineering say the technology could be used to endow crops with important traits, especially in places with high rates of malnutrition and hunger. One variety of rice has been modified with genes from corn and a common soil bacterium that together produce beta carotene, which the human body uses to make vitamin A. The lack of the vitamin causes blindness in hundreds of thousands of children in Asia and Africa each year.

The so-called golden rice, in development since the 1990s, has long been a flashpoint in the debate over genetic engineering. Several anti-GMO groups, including Greenpeace, have organized protests over it, saying, without evidence, that it could pose unforeseen risks to human health and the environment while profiting big agrochemical companies. Proponents have accused activists of essentially having blood on their hands for delaying the crops approval: How many poor people in the world must die before we consider this a crime against humanity? asked a letter signed by more than 100 Nobel laureates earlier this month, petitioning Greenpeace to change its stance.

But even if Greenpeace changes its stance, the rice is not ready yet. In 2013, a trial that had found a bowl of the rice supplied more than half of a childs daily vitamin A requirement was deemed to have been conducted unethically because it had not been disclosed to the participants that they were eating genetically modified rice. That set back any plans to distribute it. And last spring, the nonprofit institute responsible for the rices development said it did not grow well enough to be embraced by farmers. Golden rice may one day help save lives. But not yet.

Chipotles burritos used to be stuffed with GMOs.

Actually: Only the cooking oil and the tortillas had ingredients from GMO crops.

Last year, the restaurant chain ran its G-M-Over It campaign to announce the elimination of GMOs from its menu. But according to the company website, only its soy cooking oil and the soy and corn in its tortillas had come from genetically modified crops. Even the corn in its roasted chili-corn salsa was not genetically modified. The GMO corn we eat usually comes in the form of syrup, starch or oil, though a small amount of sweet corn, as it is known, is also genetically engineered.

Almost all soybeans and most corn grown in the United States are modified so farmers can spray them with glyphosate (the main ingredient in Roundup) to kill weeds without harming the crop. But according to Andrew Kniss, an agronomist at the University of Wyoming, Chipotles replacement ingredients also came from crops cultivated with weed-killers just different ones.

Huge chickens are GMOs.

Actually: They got that way through regular breeding.

Over the last 60 years, chickens have become bigger. They grow faster and require less food per pound of meat they produce. But despite what you may read on the internet, their DNA has not been manipulated in a laboratory. Their size results from farmers selecting and crossbreeding the ones with the most desirable qualities, and because Americans like white meat, that process has produced birds with oversized breasts that their legs can barely support.

Those chickens, like most farm animals, do eat feed made from genetically engineered corn and soybeans. But any added or modified genes, and the proteins they produce, are broken down during digestion. And the nutrients in eggs, meat and milk have been found to be the same as those from animals fed with plants that were not genetically engineered.

Some chickens have been engineered so their eggs contain an enzyme that can treat a rare disease. And some goats have also been modified to produce enzymes that are lacking in some humans. But the animals that generate these farmaceuticals are not sold for human consumption. And the only genetically modified animal to be approved for sale in the United States, a salmon engineered to grow faster to its market size, is not yet available.

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Sunday Reader: Square watermelons and other misconceptions about GMOs - Bend Bulletin

A team of Chinese scientists have reportedly used cloning technology to biologically engineer a beagle puppy, Long Long, the worlds first dog cloned from a genetically altered parent.

Long Long was cloned by Lai Liangxue and a team of researchers at Sino Gene and born in May. Long Longs father, Apple, was genetically engineered in the same lab for the team to study atherosclerosis, which occurs when arteries are clogged. The beagle puppy is believed to be the first dog in human history to be cloned from a genetically modified parent, according to a report by the Daily Mail (U.K.).

In 2015, Lais team used gene editing to breed beagles without the myostatin gene, the absence of which causes increased muscle, according to a report by the Massachusetts Institute of Technologys Technology Review. Two of Lais beagles, Hercules and Tiangou, were designed to have twice the muscle mass of a normal beagle.

Lai has said his team will be able to genetically engineer super dogs that run faster, are stronger or have other desirable characteristics and then use the new technology used to create Long Long to produce entire batches of cloned dogs, which could be used for police forces and hunting.

With this technology, by selecting a certain gene of the dog, we can breed an animal with more muscles, better sense of smell and stronger running ability, which is good for hunting and police applications, Lai told China Plus on July 6.

David King, the director of Human Genetics Alert, told the Sunday Express (U.K.) hes concerned this development could eventually lead to the genetic engineering of humans.

Its true that the more and more animals that are genetically engineered using these techniques brings us closer to the possibility of genetic engineering of humans, King said.

Its unclear whether humans have ever been cloned. According to a report by U.S. News and World Report, South Korean scientist Hwang Woo-suk said he successfully cloned a human embryo in 2004 at Seoul National University, but he later was forced to officially retract those published claims after an investigation found no evidence of his alleged success.

Hwang lost his position at SNU, but he went on to create the Sooam Biotech Research Foundation, which charges people $100,000 to clone dogs and has partnered with Chinese scientists at Boyalife Group to produce primate clones.

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Chinese scientists clone genetically altered dog, say they're ready to mass produce 'super dogs' - TheBlaze.com

July 13, 2017

Immune cells with a general knack for recognizing and killing many types of infected or abnormal cells also can be engineered to hunt down cells with specific targets on them to treat cancer, researchers at The University of Texas MD Anderson Cancer Center report in the journal Leukemia.

The team's preclinical research shows that natural killer cells derived from donated umbilical cords can be modified to seek and destroy some types of leukemia and lymphoma. Genetic engineering also boosts their persistence and embeds a suicide gene that allows the modified cells to be shut down if they cause a severe inflammatory response.

A first-in-human phase I/II clinical trial of these cord-blood-derived, chimeric antigen receptor-equipped natural killer cells opened at MD Anderson in June for patients with relapsed or resistant chronic lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL), or non-Hodgkin lymphoma. All are cancers of the B cells, another white blood cell involved in immune response.

"Natural killer cells are the immune system's most potent killers, but they are short-lived and cancers manage to evade a patient's own NK cells to progress," said Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy.

"Our cord-blood derived NK cells, genetically equipped with a receptor that focuses them on B-cell malignancies and with interleukin-15 to help them persist longerpotentially for months instead of two or three weeksare designed to address these challenges," Rezvani said.

Moon Shots Program funds project

The clinical trial is funded by MD Anderson's Moon Shots Program, designed to more rapidly develop life-saving advances based on scientific discoveries.

The chimeric antigen receptor (CAR), so-called because it's added to the cells, targets CD19, a surface protein found on B cells.

In cell lines and mouse models of lymphoma and CLL, CD19-targeted NK cells killed cancer cells and extended survival of animals compared to simply giving NK cells alone. Addition of IL-15 to the CD19 receptor was crucial for the longer persistence and enhanced activity of the NK cells against tumor cells.

NK cells are a different breed of killer from their more famous immune system cousins, the T cells. Both are white blood cells, but T cells are highly specialized hunters that look for invaders or abnormal cells that bear a specific antigen target, kill them and then remember the antigen target forever.

Natural killers have an array of inhibitory and activating receptors that work together to allow them to detect a wider variety of infected, stressed or abnormal cells.

"By adding the CD19 CAR, we're also turning them into guided missiles," said Elizabeth Shpall, M.D., professor of Stem Cell Transplantation and Cell Therapy.

Using a viral vector, the researchers transduce NK cells taken from cord blood with the CD19 CAR, the IL-15 gene, and an inducible caspase-9-based suicide gene.

Cell line tests found the engineered NK cells to be more efficient killers of lymphoma and CLL cells, compared to unmodified NK cells, indicating the engineered cells' killing was not related to non-specific natural killer cell cytotoxicity.

Another experiment showed the engineered cord blood NK cells killed CLL cells much more efficiently than NK cells taken from CLL patients and engineered, highlighting the need to transplant CAR-engineered NK cells from healthy cord blood rather than use a patient's own cells.

Suicide gene to counter cytokine release syndrome

Mouse model lymphoma experiments using a single infusion of low dose NK cells resulted in prolongation of survival. At a higher, double dose, none of the mice treated with the CD19/IL-15 NK cells died of lymphoma, with half surviving for 100 days and beyond. All mice treated with other types of NK cells died by day 41.

A proportion of mice treated with the higher dose of engineered NK cells died of cytokine release syndrome, a severe inflammatory response that also occurs in people treated with CAR T cells.

To counteract this toxicity, the researchers incorporated a suicide gene (iC9) that can be activated to kill the NK cells by treatment with a small-molecule dimerizer. This combination worked to swiftly reduce the engineered NK cells in the mouse model.

Subsequent safety experiments were conducted in preparation for the clinical trial. Rezvani, the principal investigator of the clinical trial, says the protocol calls for vigilance for signs of cytokine release syndrome, treatment with steroids and tocilizumab for low-grade CRS with AP1903 added to activate the suicide gene for grade 3 or 4 CRS.

NK CARs available off the shelf

T cells modified with chimeric antigen receptors against CD19 have shown efficacy in clinical trials. In these therapies, a patient's own T cells are modified, expanded, and given back to the patient, a process that takes weeks. Finding a matched donor for T cells would be a challenge, but would be necessary because unmatched T cells could attack the recipient's normal tissue - graft vs. host disease.

Rezvani and Shpall have given patients cord-blood derived NK cells in a variety of clinical trials and found that they do not cause graft vs. host disease, therefore don't have to be matched. NK cells can be an off-the-shelf product, prepared in advance with the necessary receptor and given promptly to patients.

"CAR NK cells are scalable in a way that CAR T cells are not," Rezvani noted.

A strength of T cells is the development of memory cells that persist and repeatedly attack cells bearing the specific antigen that return. NK cells do not seem to have a memory function, but Rezvani says the experience of the longer-lived mice, which are now more than a year old, raises the possibility that a prolonged NK cell attack will suffice.

Shpall, Rezvani and colleagues are developing cord blood NK CARs for other targets in a variety of blood cancers and solid tumors.

MD Anderson and the researchers have intellectual property related to the engineered NK cells, which is being managed in accordance with the institution's conflict-of-interest rules.

Shpall founded and directs MD Anderson's Cord Blood Bank, originally established to provide umbilical cord blood stem cells for patients who need them but cannot get a precise donor match. Donated by mothers who deliver babies at seven Houston hospitals and two others from California and Michigan, the bank now has 26,000 cords stored. MD Anderson researchers pioneered the extraction and expansion of NK cells from umbilical cords.

Explore further: Multiple myeloma patient study shows promise for natural killer cells

Immune cellular therapy is a promising new area of cancer treatment. Anti-cancer therapeutics, such as chimeric antigen receptor (CAR) modified T cells, can be engineered to target tumor-associated antigens to attack and ...

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On a hill above the cold waters around Prince Edward Island, technicians painstakingly create fertilized Atlantic salmon eggs that include growth-enhancing DNA from two other fish species. The eggs will be shipped to tanks in the high rainforest of Panama, where they will produce fish that mature far more quickly than normal farmed salmon.

More than 20 years after first seeking approval from the U.S. Food and Drug Administration, AquaBounty Technologies of Maynard, Massachusetts, plans to bring these "AquAdvantage" fish to the U.S. and Canadian markets next year. And in the small town of Albany, Indiana, workers will soon begin converting a land-based aquaculture facility to produce about 1,300 U.S. tons of these salmon annually, in the first U.S. facility to generate GE animals for human consumption.

The company also plans to open a second aquaculture facility at Prince Edward Island if it can rise above its latest round of legal battles and persuade grocery stores and restaurants to snap up the genetically engineered fish. Before the FDA cleared the salmon for consumption in 2015, in its first approval of GE animal protein as human food, it received 1.8 million messages opposing these fish. Perhaps more substantively, many outside researchers remain concerned about AquaBounty's plans.

Safety and nutrition

Aquaculture specialists generally aren't skeptical about whether the fish will be healthy to eat, although that's one issue hinted at in a lawsuit multiple organizations, including Friends of the Earth, have filed against the FDA. Dana Perls, senior food and technology campaigner with Friends of the Earth in Berkeley, California, says the FDA didn't fully examine questions about eating the salmon initially raised by Health Canada, that country's public health department including susceptibility to disease and potential allergic reactions.

"This is a poorly studied, risky, and unlabeled genetically engineered fish," she says, adding that more than 80 U.S. grocery chains have committed not to buy it. However, Health Canada eventually concluded that fillets derived from AquAdvantage salmon "are as safe and nutritious as fillets from current available farmed Atlantic salmon," and approved the fish for consumption in 2016.

"There's no reason to suspect these fish from a food safety perspective," says Cyr Couturier, chair of aquaculture programs at Memorial University's Marine Institute in St. John's, Newfoundland. "They have no unnatural products that humans wouldn't otherwise consume."

Similar transgenic salmon created by a decades-long Fisheries and Oceans Canada research program tested well within normal salmon variations, adds Robert Devlin, engineering research scientist at the agency in North Vancouver, British Columbia. But critics do raise two other main concerns about AquaBounty's quest: the economic sustainability of the land-based approach, and the environmental risk to ecosystems if the fish escape.

Fish on land

AquaBounty will raise its GE fish in land-based recirculating aquaculture systems, known as RAS basically huge aquaria designed to minimize water use, maximize resources and accommodate high stocking densities. "While farming salmon in sea cages is less expensive and less technologically complex than a land-based farm," the company's website points out, "sea cages are susceptible to a number of hazards such as violent storms, predators, harmful algal blooms, jellyfish attacks, fish escapes, and the transmission of pathogens and parasites from wild fish populations."

Given the potential opportunity to achieve greater production control and avoid some of the environmental concerns of sea farms, many RAS projects have launched around the world in the past decade. However, most of these projects are small, and many have failed or are struggling.

The big problem is cost. RAS facilities need much more capital than ocean farms with similar production rates, and they're expensive to operate.

"Land-based systems use a lot of freshwater, even though it's recirculated, and a lot of electricity," notes Couturier. Such systems "operate at an economic disadvantage because much of their cost goes toward creating growing conditions occurring naturally within the ocean," summed up one 2014 report that found producing Atlantic salmon in Nova Scotia would not be economically feasible.

AquaBounty, which is buying its Indiana plant from a collapsed RAS venture, expects to beat these odds mainly because its GE salmon reach market size in about half the time of normal farmed salmon in 1618 months rather than 2836 months, the company says. Ravenous as they are, with their growth hormones continually wired on, the fish still require about a quarter less feed than normal fish. (Although farmed salmon are very efficient at converting food to flesh a pound of feed converts close to a pound of flesh feed remains a major expense.)

The company also says that salmon in its RAS facilities won't need vaccines or antibiotics because it will tightly control conditions. However, "they will have some disease issues of course, as will any animal that's reared in high densities," Couturier predicts.

If AquaBounty can compete on cost, there will be some justification for promoting its product as "the world's most sustainable salmon." In addition to requiring less feed, growing fish in Indiana or Prince Edward Island can slash the high carbon costs of flying fish from Norway or Chile, two leading suppliers of farmed salmon in the U.S.

Still, says Couturier, "I wish them all the best, but I think it will be a small-scale niche for at least a decade."

Losing GE fish

Many aquaculture scientists remain uneasy about the environmental risk to wild ecosystems if transgenic fish slip out of their farms. Although other agencies will presumably be involved in assessing risk as the projects advance, "the FDA has no in-house capacity to evaluate or understand the ecological consequences of transgenics in an aquatic ecosystem," says Conner Bailey, professor emeritus of rural sociology at Auburn University in Alabama. "And once you get anything into an aquatic ecosystem, it's really hard to control."

AquaBounty's protection scheme begins with multiple levels of physical barriers in its RAS facilities. Additionally, the salmon are all female and "triploid" (their DNA is in three rather than two sets of chromosomes) so they can't reproduce. However, scientists say neither of these measures can be 100 percent effective at preventing transgenic fish from escaping, disrupting local ecosystems, and potentially breeding in the wild.

More generally, while AquaBounty is committed to land-based systems, there are concerns that it's also creating far more GE eggs than it needs for its own production. Other industry groups, such as the Atlantic Salmon Federation, worry that other producers AquaBounty sells to might not be so careful, or that other companies around the world might move ahead with similar projects but without the same precautions. And all bets on risk are off if GE fish are raised in the ocean, where fish routinely escape, sometimes in large numbers.

Devlin's group has extensively modeled the results of accidental releases, studying groups of transgenic and non-transgenic fish in "naturalized" aquatic test beds that are exposed to variations in conditions, such as food supply. Transgenic fish often behave quite differently, and the results have varied from peaceful coexistence to one experiment in which fully transgenic fish killed off all their competitors.

"In the multitude of different environments that exist in nature, the uncertainty is too great to make a reliable prediction of what the impact would be," he says.

GE or selective breeding?

Does the fast growth of AquAdvantage salmon justify taking on these unknown risks? Scientists point out that today's selective breeding research programs, built on genomics and other tools of modern biology, also have turbocharged fish development. "Some strains of rainbow trout, which have been selected for fast growth for 150 years, grow incredibly fast compared to wild-type fish," Devlin says. In fact, he says, his lab work across various species suggests that "the absolute fastest growth you can achieve either by domestication or by transgenesis seems to be very similar."

"Today's farmed salmon have had more than 10 generations of selection applied to them, and they are growing at more than double the rate compared to the 1970s," says Bjarne Gjerde, senior scientist at Nofima in Troms, Norway.

Farmed fish also must excel in many traits besides growth, such as disease resistance and food quality, he emphasizes. "Most of the traits we are breeding for are governed by many, many genes with small effects," he says. "That's a real challenge if you just want to take short cuts with genetic engineering."

When and if AquaBounty rises above all its challenges into a groundbreaking success in North America, the firm will send a signal around the world to unleash efforts for commercializing GE fish, observers say. Friends of the Earth's Perls remains hopeful that legal barriers and consumer boycotts will stop AquaBounty in its tracks. If not, "GE salmon could set a precedent to the approval of other GE animals in the pipeline, from fish to chickens, pigs, and cows," she says. "It is critical that we don't approve other GE animals without robust regulations and full environmental reviews to ensure that we're prioritizing human and environmental safety over profit."

"Fish are probably where transgenic animals will emerge, because it's much cheaper to maintain a herd of catfish or salmon than cattle or sheep or pigs," says Bailey.

This story was first published by Ensia, an environmental news magazine from the University of Minnesota.

This article originally appeared at PRI's The World.

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Genetically engineered salmon is coming to America - The Week Magazine

Xconomy New York

With influenza season a few months away, Sanofi is giving its vaccine operations a shot in the arm by acquiring Protein Sciences, a company that has a commercial vaccine, Flublok, and manufactures it using genetic engineering and cell culture instead of the traditional method that relies on millions of chicken eggs.

According to the companies, Sanofi (NYSE: SNY) will pay privately held Protein Sciences, of Meriden, CT, $650 million up front. The deal puts Flublok in the hands of a big company with resources to market the product globally. Protein Sciences stands to gain an additional $100 million if its vaccine hits certain unspecified milestones under Sanofi.

Most influenza vaccine is produced by a decades-old process of culturing the virus in chicken eggs. Vaccine makers have been trying to move beyond it for years; egg production requires long lead times and is susceptible to many factors, like contamination and chicken illnesses, that can create shortages.

Conversely, cell cultures can be frozen until needed, notes the FDA. This feature gives vaccine makers more flexibility to match demand. Cell culture has other advantages. Some flu strains grow better and faster in cell culture, which allows vaccine makers to produce vaccines and bring them to the market more quickly, the FDA says.

FluBlok, which got an FDA green light in 2013, is a recombinant vaccine, which means Protein Sciences uses genetic engineering to make the single protein from the influenza virus that is needed for protection. The vaccine is then produced in cell culture. This approach, Protein Sciences says, matches the viral strain that is circulating in a given flu season. Last year, the FDA approved a quadrivalent version of Flublok, a version of the Protein Sciences vaccine developed to protect against four flu strains.

Despite the speed advantages of cell culture production, as well as Protein Sciences ability to match its vaccine to circulating viral strains, the approach does havesome challenges. Like egg culture, cell culture vaccine production faces contamination risks. Also, making vaccines from cell culture is a more expensive way to produce vaccines.

Nonetheless, pharma companies are pursuing cell culture production to diversity their vaccine portfolio mix. In some cases, companies have constructed vaccine manufacturing plants as part of a Biomedical Advanced Research and Development Authority initiativeto build the capability to respond to a viral outbreak. BARDA formed the plan following the 2009 H1N1 influenza pandemic. One site constructed under this plan operates in North Carolina. Under a government contract, Novartis (NYSE: NVS built a vaccine production site in Holly Springs, NC, capable of quickly responding to a viral emergency. That site is now operated by Seqirus, a division of Australian company CSL formed through the 2015 acquisition of Novartis influenza vaccine business.

Protein Sciences facility in Pearl River, NY, will give Sanofi a fifth site for seasonal vaccine production. The Paris-based company currently produces flu vaccine in northwestern France, Mexico, China, and Pennsylvania.

The boards of directors of both Sanofi and Protein Sciences have approved the acquisition, which still needs the approval of regulators. The companies expect to close the deal in later this quarter.

Image of H1N1 influenza by Flickr user NIAIDvia a Creative Commons license.

Frank Vinluan is editor of Xconomy Raleigh-Durham, based in Research Triangle Park. You can reach him at fvinluan [at] xconomy.com

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Sanofi Shores Up Flu Vaccine Business With Protein Sciences Deal - Xconomy

In BriefThe age of gene editing and creation will be upon us in thenext few decades, with the first lifeform having already beenprinted. Stanford University questions the ethics of prospectivestudents by asking a question we should all be thinking about. Stanfords Moral Pickle

When bioengineering students sit down to take their final exams for Stanford University,they are faced with a moral dilemma, as well as a series of grueling technical questions that are designed to sort the intellectual wheat from the less competent chaff:

If you and your future partner are planning to have kids, would you start saving money for college tuition, or for printing the genome of your offspring?

The question is a follow up to At what point will the cost of printing DNA to create a human equal the cost of teaching a student in Stanford? Both questions refer to the very real possibility that it may soon be in the realm of affordability to print off whatever stretch of DNA you so desire, using genetic sequencing and a machine capable of synthesizing the four building blocks of DNA A, C, G, and T into whatever order you desire.

The answer to the time question, by the way, is 19 years, given that the cost of tuition at Stanford remains at $50,000 and the price of genetic printing continues the 200-fold decrease that has occurred over the last 14 years. Precursory work has already been performed; a team lead by Craig Venter created the simplest life form ever known last year.

Stanfords moral question, though, is a little trickier. The question is part of a larger conundrum concerning humans interfering with their own biology; since the technology is developing so quickly, the issue is no longer whether we can or cant,but whether we should or shouldnt. The debate has two prongs: gene editing and life printing.

With the explosion of CRISPR technology many studies are due to start this year the ability to edit our genetic makeup will arrive soon. But how much should we manipulate our own genes? Should the technology be a reparative one, reserved for making sick humans healthy again, or should it be used to augment our current physical restrictions, making us bigger, faster, stronger, and smarter?

The question of printing life is similar in some respects; rather than altering organisms to have the desired genetic characteristics, we could print and culture them instead billions have already been invested. However, there is theadditional issue of playing God by sidestepping the methods of our reproduction that have existed since the beginning of life. Even if the ethical issue of creation was answered adequately, there are the further questions ofwho has the right to design life, what the regulations would be, and the potential restrictions on the technology based on cost; if its too pricey, gene editing could be reserved only for the rich.

It is vital to discuss the ethics of gene editing in order to ensure that the technology is not abused in the future. Stanfords question is praiseworthy because it makes todays students, who will most likely be spearheading the technologys developments, think about the consequences of their work.

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Stanford's Final Exams Pose Question About the Ethics of Genetic Engineering - Futurism