Category Archives: Genetic Engineering

Stermina Therapeutics

This is another mRNA vaccine project, based at Shanghai East Hospital of Tongji University. The CEO of Stermina told Chinese state media at the end of January that manufacturing has already begun, and doses could be ready for human testing sometime in March.

Imperial College London

A team of British scientists are currently testing their own DNA-based vaccine in mice at labs in Imperial College London. The researchers are looking for funding partners to advance the candidate into human testing later this year.

Several other companies are also developing protein-based vaccines. These include:

GlaxoSmithKline (GSK)

One of the worlds leading vaccine manufacturers, GSK is lending its technology to a Chinese firm called Clover Biopharmaceuticals to work on a coronavirus vaccine. Through the partnership, Clover will be producing viral proteins, and GSK will be providing its proprietary effectiveness-boosting compounds, known as adjuvants. Neither company has provided a testing timeline.

Novavax

Novavax got a jump on the competition from its previous work developing vaccines against SARS and MERS. The Maryland-based company announced in February that it had generated several candidates comprised of recombinant protein nanoparticles derived from the SARS-CoV-2 spike protein. Company representatives said they expect to complete animal testing soon and move to the first phase of human trials by the end of spring 2020.

Altimmune

Unlike its competitors, this Maryland-based company is developing a vaccine that gets sprayed into patients noses, not injected into their arms. Best known for its nasal-spray flu vaccine, Altimmune announced in February that it had completed the design and prototyping of a vaccine against Covid-19 and is now advancing it toward animal testing and manufacturing for human trials.

Vaxart

This Bay Area biotech is the only one so far developing an oral vaccine against Covid-19. In January, the company announced plans to generate candidates based on the published genome of SARS-CoV-2, but no further timelines have been released.

Expres2ion

This Denmark-based biotech firm is leading a European consortium of vaccine developers to tackle Covid-19. It uses insect cells from fruit flies to produce viral antigens. The company aims to test its candidate vaccine in animal models later this year.

Generex Biotechnology

Four companies in China have contracted with Florida-based Generex to develop a vaccine using the companys proprietary immune-activating technology. Company representatives say it could have a candidate ready for human trials as early as June.

Vaxil Bio

This Israeli immunotherapy company normally specializes in cancer. But last month representatives announced they had discovered a combination of proteins they believe will be an effective vaccine against Covid-19. The company plans to start manufacturing doses for initial testing and looking for partners to scale up further if that goes well.

iBio

This Texas-based biotech company uses modified relatives of the tobacco plant to grow viral proteins for vaccines. The company is partnering with a Chinese vaccine maker to put its FastPharming platform to work on a Covid-19 vaccine. Company officials expect to have a candidate ready for animal testing later this summer.

Baylor College of Medicine / New York Blood Center

Peter Hotezs group is pushing for funding to test their SARS vaccine against the Covid-19. He says they already have about 20,000 doses ready to be deployed for clinical trials. These researchers are simultaneously working on developing a new vaccine from scratch, based on the binding receptor domain of the new virus, SARS-Cov-2, but that will take several years to develop.

University of Queensland

A team of Australian researchers, with funding from CEPI, have developed a vaccine candidate they say is ready to move forward into human testing. It relies on a molecular clamp technology invented in the lab of molecular virologist Keith Chappell, which helps stabilize viral proteins so they have the same shape theyd have on the surface of the virus. The group is now intending to ramp up production for clinical trials.

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Is There a Coronavirus Vaccine? Here's Everything You Need to Know - WIRED

Exponential change doesnt come from incremental improvements, according to Michael Gagne, founder and CXO (chief experience officer), ARTeSYN Biosolutions. This truth seems especially relevant in bioprocessing, where companies are frustrated with existing supply chains, which are full of pain points and resistant to being improved link by link. Companies need a comprehensive solution. To eliminate multiple pain points all at once, companies need Bioprocessing 4.0.

Gagne states that the pains driven approach to moving to a facility of the future does away with the biggest obstacle to exponential progress: complacency in supplier selection or product design. End users or original equipment manufacturers, he argues, require a push to reject these inefficiencies and respond with urgency when given a chance to collaborate on something that fits their needs and promises to advance their interests. Suppliers, he continues, should emphasize cooperation with end users, and not competition with their peers, when working toward a pains-driven solution.

Many manufacturers are stuck in trying to simply optimize what they are doing, rather than take the leap and make a paradigm shift to a facility of the future, Gagne continues. The right mindset is the key to really make this transition. That and a deep understanding of the major problems plaguing biomanufacturing today. If traditional facilities are so great, why do they inspire so little confidence among the biomanufacturers who are pioneering cell and gene therapies? Why is the next-generation facilitythe facility of the futurebecoming a standard instead of remaining an anomaly in biomanufacturing? The traditional approach has flaws that have pretty much become a natural part of biomanufacturing, but that need not be so.

Typical flaws, or pain points, are instances of downtime. According to Gagne, downtime can be caused by parts washing, cleaning validation, leakage, high hold-up volumes, kinking in single-use (SU) tubing, and human error. He adds that all these sources of downtime can be eliminated at once, provided biomanufacturers embrace an exponential approach.

We have already seen an exponential approach to the facility of the future design enabling a 10-fold reduction in the cost of setting up and running a bioprocessing facility for a global manufacturer, asserts Gagne. Thats because we didnt try to squeeze more out of the manufacturers existing solutions. Instead, we chose the more challenging route of searching for the most forward-looking single-use technology. Even with the issues accompanying single-use technology, its the far better option.

If you listen to the market and where its headed, anything short of a cutting-edge leap wont suffice, he continues. Confronting the rising wave of cell and gene therapies as a viable clinical option will require a substantial shift in the industrys approach to everything from facilities to hardware to software design. It will push end users to reconsider their reliance on decades-old technology and challenge their perception of how far single-use technology has advanced today and how to make it work for them.

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Response to a 'Pains Driven' Approach to Facilities of the Future - Genetic Engineering & Biotechnology News

A CORONAVIRUS vaccine won't be ready for another year - and will miss the 'first wave' of the bug, Britain's top doctor has warned.

Professor Chris Whitty said it would be "lucky" to get a booster for Covid-19 in 2020, though existing drugs could play a role.

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And the Chief Medical Officer added that even if we did get a vaccine for the deadly bug it would "not get us out of a hole now."

He said: "I think ... a year would be lucky to get this - so we will not have a vaccine available for the first wave if we have a first wave."

Despite this, Prof Whitty said other existing treatments may work in high-risk groups although they would not be "perfect".

Prof Whitty made the revelation while being grilled by MPs by the House of Commons Health and Social Care Committee on Covid-19.

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Health Secretary Matt Hancock also admitted that a vaccine to treat the deadly bug was months away.

It comes after scientists at a genetic engineering company in Texas last month claimed they had finished developing the first coronavirus vaccine.

However, they admitted it could still be two years before the vaccine is available to use as it now needs to be tested in animal experiments before human trials can begin.

Chinese doctors are also stepping up their efforts to develop a vaccine as soon as possible.

Health chiefs are relying on the summer to mitigate an outbreak in Britain, and hope that Chinese efforts will delay the spread until the weather warms up.

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They hope that coronavirus will behave like flu, which spreads far more slowly during the summer, buying time to develop a vaccine in case it returns next winter.

"Sunlight kills viruses quickly. Sars pretty much died in July and August [2003] and it's quite plausible we'll see that here," Professor Paul Hunter, of the University of East Anglia, said.

"In summer schools are closed and people are also out of doors more. If you're walking around in the sunshine you are much less likely to spread infection than if you're cramped up together to keep warm indoors."

The number of cases of Covid-19 in the UK has surged to 90 today - with three new cases confirmed in Scotland.

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Health bosses say the best way to protect yourself is to wash your hands with soap and water for the time it takes to sing Happy Birthday twice.

Happy Birthday takes about 20 seconds to sing twice and is said to be the perfect number to clean your hands to thoroughly.

You should also not touch your eyes, nose or mouth with unwashed hands and avoid close contact with people who are sick.

Cleaning and disinfecting objects and surfaces which you may have touched is also important.

Dr Daniel Atkinson, clinical lead atTreated.com, said: "Hygiene is incredibly important to ward off any viruses.

What to do if you're worried you've got coronavirus

The new coronavirus is continuing to sweep its way across the globe with Britain seeing more cases in people who aren't linked to outbreaks overseas.

Symptoms of Covid-19 can include:

In most cases, you won't know whether you have a coronavirus or a different cold-causing virus.

But if a coronavirus infection spreads to the lower respiratory tract, it can cause pneumonia, especially in older people, people with heart disease or people with weakened immune systems.

It is incredibly contagious and is spread through contact with anything the virus is on as well as infected breath, coughs or sneezes.

The best way to prevent catching any form of coronavirus is to practice good hygiene.

If you have cold-like symptoms, you can help protect others by staying home when you are sick and avoiding contact with others.

You should also cover your mouth and nose with a tissue when you cough and sneeze then throw it away and wash your hands.

Cleaning and disinfecting objects and surfaces which you may have touched is also important.

Meanwhile, leading symptom-checking provider to the NHSDoctorlinkhas been updated to help identify patients' risk of having coronavirus.

Source: NHS

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"Make sure to wash your hands thoroughly - for at least 20 seconds - and cover your mouth and nose when you cough or sneeze.

"If you can, avoid contact with sick people and avoid shaking hands with anyone displaying flu-like symptoms."

Globally, there are currently over 96,000 cases of coronavirus and more than 3,000 deaths from the bug worldwide.

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Coronavirus vaccine wont be ready for another year and will miss first wave of bug, top doc warns - The Irish Sun

Genetic engineering is the process of using technology to change the genetic makeup of an organism - be it an animal, plant or a bacterium.

This can be achieved by using recombinant DNA (rDNA), or DNA that has been isolated from two or more different organisms and then incorporated into a single molecule, according to the National Human Genome Research Institute (NHGRI).

Recombinant DNA technology was first developed in the early 1970s, and the first genetic engineering company, Genentech, was founded in 1976. The company isolated the genes for human insulin into E. coli bacteria, which allowed the bacteria to produce human insulin.

After approval by the Food and Drug Administration (FDA), Genentech produced the first recombinant DNA drug, human insulin, in 1982. The first genetically engineered vaccine for humans was approved by the FDA in 1987 and was for hepatitis B.

Since the 1980s, genetic engineering has been used to produce everything from a more environmentally friendly lithium-ion battery to infection-resistant crops such as the HoneySweet Plum. These organisms made by genetic engineering, called genetically modified organisms (GMOs), can be bred to be less susceptible to diseases or to withstand specific environmental conditions.

But critics say that genetic engineering is dangerous. In 1997, a photo of a mouse with what looked like a human ear growing out of its back sparked a backlash against using genetic engineering. But the mouse was not the result of genetic engineering, and the ear did not contain any human cells. It was created by implanting a mold made of biodegradable mesh in the shape of a 3-year-old's ear under the mouse's skin, according to the National Science Foundation, in order to demonstrate one way to produce cartilage tissue in a lab.

While genetic engineering involves the direct manipulation of one or more genes, DNA can also be controlled through selective breeding. Precision breeding, for example, is an organic farming technique that includes monitoring the reproduction of species members so that the resulting offspring have desirable traits.

A recent example of the use of precision breeding is the creation of a new type of rice. To address the issue of flooding wiping out rice crops in China, Pamela Ronald, a professor of plant pathology at the University of California-Davis, developed a more flood-tolerant strain of rice seed.

Using a wild species of rice that is native to Mali, Ronald identified a gene, called Sub1, and introduced it into normal rice varieties using precision breeding creating rice that can withstand being submerged in water for 17 days, rather than the usual three.

Calling the new, hardier rice the Xa21 strain, researchers hope to have it join the ranks of other GMOs currently being commercially grown worldwide, including herbicide-tolerant or insect-resistant soy, cotton and corn, within the next year, Ronald said. For farmers in China, the world's top producer and consumer of rice, being able to harvest enough of the crop to support their families is literally a matter of life and death.

Because Ronald used precision breeding rather than genetic engineering, the rice will hopefully meet with acceptance among critics of genetic engineering, Ronald said.

"The farmers experienced three to five fold increases in yield due to flood tolerance," Ronald said at a World Science Festival presentation in New York. "This rice demonstrates how genetics can be used to improve the lives of impoverished people."

Got a question? Email it to Life's Little Mysteries and we'll try to answer it. Due to the volume of questions, we unfortunately can't reply individually, but we will publish answers to the most intriguing questions, so check back soon.

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What's Genetic Engineering? | Live Science

Were proud to be Nuclear Free. We want to be Predator Free. But what about GE Free?Is it time to have a national conversation about genetic engineering?

Dr Sean Simpson Source: 1 NEWS

As I sit opposite Dr Sean Simpson in his companys high-tech Chicago HQ, I cant help but notice his T-Shirt.

Firstly, because its bright yellow. Secondly because hes worn it before he tells me he owns three, all in various stages of fading. The message on the front however couldnt be clearer Science Doesnt Care What You Believe.

Simpson is a man on a mission to reduce the worlds carbon footprint a mission that began in New Zealand.

It was a very basic set up when he started his company LanzaTech with the late Dr Richard Forster in an Auckland basement back in 2005.

Our first experiments were done with a rotisserie unit bought from The BBQ Warehouse and two defunct refrigeration units from the local dairy, he laughs.

Both scientists, Simpson and Forster set out to make a clean burning fuel, ethanol from waste products i.e. pollution and rubbish. They succeeded - the company is now valued at over $1 billion.

Its understandable then that when LanzaTech announced in 2014 it was relocating its head office from Auckland to Chicago there was a sense that New Zealand had missed a major opportunity to retain this innovative and world-leading company.

Simpson acknowledges that New Zealand is a fantastic place in which to start a business, but one of the key reasons for their move was our stance on genetic engineering.

LanzaTechs process uses microbes that secrete ethanol when they are fed waste gases but by genetically modifying the bugs, they can produce a range of other chemicals i.e. not just ethanol. Those chemicals can be used to make things we need every day without contributing to our carbon footprint, and you can't scale that technology in New Zealand.

The government's interim climate change committee has pointed to that stance (which predominantly confines GE to the lab), as a possible barrier to lowering our carbon emissions.

GE also has potential applications in pest control remember were aiming to be predator free by 2050. However, for now, the rules arent likely to change.

Professor Peter Dearden, the Director of Genomics Aotearoa from the University of Otago says pest control, agriculture and medicine are key areas where Kiwis could benefit from GE technology but that our regulations have had a chilling effect on research as much of it depends on whether companies can take their technology to market.

The result of which is that were not doing critical work we need to do in the laboratory because the chances of it being used are so small".

Dearden believes our position will only change if the issue is personalised the best approach is for us to look at NZ solutions to NZ problems, things like Kauri dieback, invasive wasps. The key thing is making it about people, if you or I see a personal benefit then were much more likely to see it differently".

Ultimately, he says its about weighing up the risks and benefits so the public can decide.

The Minister for the Environment, David Parker, was advised on the matter late last year by officials. His office confirmed on Friday that he is still considering it as it is not a straightforward issue.

Even though our GE rules were a factor in LanzaTech heading off-shore, Bruce Jarvis of the governments business support agency, Callaghan Innovation, says it wasnt the only reason as for NZ companies to be successful they have to be close to their market.

In the US most petrol is blended with up to 10 per cent ethanol so theres an enormous opportunity for ethanol producers there.

Jarvis says even though it can be a blow to the Kiwi psyche when a company leaves (especially when its received government start-up funding), there isnt enough focus on their legacy and ongoing benefits to NZ.

He says often whats left behind are highly skilled people who start their own companies and share what theyve learned in terms of commercialisation and thats gold for us.

Its part of the cycle, these people are entrepreneurs, they get bored quickly, this is what they love doing, they love building successful tech companies.

Its an ambition Sean Simpson shares, hes determined to come back to New Zealand for good one day to reinvest his time and talent in other tech start-ups.

In the meantime, although the sentiment behind Seans favourite T-shirt will never change, it could be a lot more faded before theres a significant change to our GE rules.

For the full story on Sean Simpsons incredible journey with LanzaTech, watch SUNDAY, on TVNZ1 at 7:30pm.

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Is it time to have a national conversation about genetic engineering? - TVNZ

Sam Erickson followed his love of science to outer space one summer during an internship at NASA. He came away fascinated by seeing into deep space by interpreting interaction between matter and infrared radiation.

Now a full-fledged researcher at the University of Minnesotas College of Biological Sciences, the 25-year-old Alaska native is immersed in something far more earthly: killing carp. His fast-moving genetic engineering project is drawing attention from around the country as a potential tool to stop the spread of invasive carp.

I want to make a special fish, Erickson said in a recent interview at Gortner Laboratory in Falcon Heights.

In short, he plans to produce batches of male carp that would destroy the eggs of female carp during spawning season. The modified male fish would spray the eggs as if fertilizing them. But the seminal fluid thanks to DNA editing would instead cause the embryonic eggs to biologically self-destruct in a form of birth control that wouldnt affect other species nor create mutant carp in the wild.

His goal is to achieve the result in a controlled setting using common carp. From there, it will be up to federal regulators and fisheries biologists to decide whether to translate the technology to constrain reproduction of invasive carp in public waters.

What were developing is a tool, Erickson said. If we could make this work, it would be a total game-changer.

Supervised by University of Minnesota assistant professor Michael Smanski, Erickson recently received approval to accelerate his project by hiring a handful of undergraduate assistants. He also traveled last month to Springfield, Ill., to present his research plan to the 2020 Midwest Fish and Wildlife Conference.

Were pretty excited about where his project is at, said Nick Phelps, director of the Minnesota Aquatic Invasive Species Research Center at the U. Things are sure moving fast. Theres excitement and caution.

Ericksons research has received funding from Minnesotas Environment and Natural Resources Trust Fund. No breeding populations of invasive carp have been detected in Minnesota, but the Department of Natural Resources has confirmed several individual fish captures and the agency has worked to keep the voracious eaters from migrating upstream from the lower Mississippi River. Silver carp, bighead carp and other Asian carps pose a threat to rivers and lakes in the state because they would compete with native species for food and habitat.

Erickson views his birth control project as one possible piece in the universitys integrated Asian carp research approach to keep invasive carp out of state waters. Already the DNR has supported electric barriers and underwater sound and bubble deterrents at key migration points. Another Asian carp-control milestone was closing the Mississippi River lock at Upper St. Anthony Falls in Minneapolis in 2015.

Shooting star

Growing up in Anchorage, Erickson had never heard of Macalester College in St. Paul. But he visited the campus at the urging of a friend and felt like he fit in. He majored in chemistry and worked for a year at 3M in battery technology. But his interests tilted toward the natural world and how to better live in cooperation with nature, he said. Erickson met with Smanski about research opportunities at the university and was hired on the spot.

Smanski, one of the universitys top biological engineers, said carp is not an easy organism to work with and Erickson lacked experience in the field. But he hired the young researcher and assigned him to the carp birth control project because he seemed to have a rare blend of determination and intelligence.

I could tell right away when I was talking to him that he was like a shooting star, Smanski said. If you set a problem in front of him, he wont stop until he solves it Hes taken this farther than anyone else.

In two short years, Smanksi said, Erickson has mastered genetic engineering to the point that his research is starting to bear fruit.

With his new complement of research assistants, Erickson aims to clear his projects first major hurdle sometime this year. The challenge is to model his experiment in minnow-sized freshwater zebrafish. The full genetic code of zebrafish like common carp is already known.

Ericksons task is to make a small change to the DNA sequence of male zebrafish, kind of like inserting a DNA cassette into the fish, he said. During reproduction, the alteration will create lethal overexpression of genes in the embryonic eggs laid by females.

By analogy, Erickson said, the normal mating process is like a symphony with a single conductor turning on genes inside each embryo, Erickson said. But the DNA modification sends in a mess of conductors and the mixed signals destroy each embryo within 24 hours.

In the lab we have to make sure were causing the disruption with no off-target effects, he said. If we can do this in zebrafish, we hope to translate it. They are genetically similar to carp.

Ericksons upcoming experimentation with tank-dwelling live carp could be painfully slow because the fish only mate once a year. But hes working his way around that problem by altering lighting conditions and changing other stimuli in his lab to stagger when batches of fish are ready to reproduce.

The birth control process projected to be affordable for fisheries managers if it receives approval is already proven to work in yeast and insects. And Erickson said the same principles of molecular genetics have been used to create an altered, fast-growing version of Atlantic salmon approved for human consumption in the U.S.

Were not building a new carp from the bottom up but its kind of a whole new paradigm, so we have to get it done right, he said.

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Solution for a scourge? University of Minnesota scientist is progressing with carp-killer tool - Minneapolis Star Tribune

Infectious disease experts warn that it's inevitable that a virus will jump from animals to humans and kill tens of millions. Here's everything you need to know:

Why are experts worried?Picture a new viral disease like the Wuhan coronavirus, now called COVID-19, that passes easily from person to person and spreads rapidly around the globe. But unlike COVID-19, which kills perhaps 2 or 3 percent of its victims, this virus kills 20 percent of those infected. Or 40 percent. It might sound like a disaster movie premise (and in fact it was, in 2011's Contagion), but viral disease experts are in wide agreement that such a pandemic is coming, and that it will inflict unimaginable devastation. The only question is when it will hit. Last September, the Global Preparedness Monitoring Board (GPMB), a group convened in 2018 by the World Bank and the World Health Organization, warned of "a very real threat" of a pandemic that would kill 50 million to 80 million people, cost $3 trillion, and create "widespread havoc, instability, and insecurity." We need only look to the recent past to see how dire things can get: The Spanish flu of 1918 killed between 50 million and 100 million (including 675,000 Americans), or about 3 percent of the global population.

Where would such a virus come from?The most likely scenario is a pathogen that jumps from animals to humans and can spread through the air. The outbreak of COVID-19 was traced to a live-animal market in Wuhan, China, where a bat virus appears to have added some genetic material from a soldierfish. Many viral diseases have been traced to animals, including HIV (which originated in chimpanzees), MERS (camels), SARS (probably bats and civet cats), and Ebola (unknown, but probably bats). Last year researchers at Johns Hopkins ran a simulation of a hypothetical coronavirus emerging from a Brazilian pig farm: The result was 65 million dead within 18 months. Another concern is a familiar very deadly virus that mutates, allowing it to spread more easily. The avian flu H5N1, for example, has proven highly lethal but not very communicable so far. The intentional or accidental release of a manmade pathogen is another threat; new genetic engineering tools have made them far easier to create. A laptop captured from ISIS in 2014 contained instructions on how to weaponize plague bacteria.

Why is this more of a problem now?Human population growth. People are encroaching on previously wild areas where unknown viruses and bacteria lurk in animals; those who become infected carry the pathogens back to densely packed cities, where disease is easily spread. The 1998 emergence of the Nipah virus, for example, was linked to deforestation in Malaysia that displaced fruit bats and put them near pig farms. Pigs became infected, and the virus then spread to farmworkers. In the past 50 years, more than 300 pathogens have emerged or re-emerged, including Zika and yellow fever. At the same time, climate change has enabled insects and animals that carry disease to expand their habitats to new regions. Human migratory patterns are a factor as well: The surge in international travel allows viruses to spread around the globe quickly. "We've created an interconnected, dynamically changing world that provides innumerable opportunities to microbes," says Richard Hatchett of the Coalition for Epidemic Preparedness Innovations. "If there's weakness anywhere, there's weakness everywhere."

Are we prepared for a major pandemic?Not at all. A report released last October by the Global Health Security Index found glaring gaps in readiness; out of 195 countries surveyed, not one was judged fully prepared to handle a major event. In the U.S. under President Trump, the federal budgets for both research and response preparation have been cut, the National Security Council's global health security unit has been disbanded, and the White House official in charge of pandemic response left his job in 2018 and has not been replaced. We're caught in a "cycle of panic and neglect," World Health Organization Director-General Tedros Adhanom Ghebreyesus said. "We throw money at an outbreak, and when it's over, we forget about it and do nothing to prevent the next one."

What needs to be done?Experts say the U.S. and other countries need to spend vastly more money on pandemic preparedness. We need to develop better diagnostic tools, stockpile drugs and vaccines, and fund research into new treatments and vaccine technologies. Above all, there needs to be an international effort to improve sanitation, medical care, and response capability in poorer countries where new diseases are most likely to arise and spread. All of this requires a major change in mindset, say experts. "The world needs to prepare for pandemics the same way it prepares for war," said Microsoft founder Bill Gates, who's invested tens of millions in viral disease research. Humanity's biggest threat, he says, is "not missiles, but microbes."

It's happened many times beforeEpidemics have been a fact of life since the first human settlements. As humans built cities and trade routes, the capacity for pandemics grew, and history is marred by many devastating outbreaks. The earliest on record dates to 430 B.C., when a pestilence that may have been typhoid fever took root in Athens, killing up to two-thirds of the city's population. In A.D. 541, the Justinian plague spread through the Mediterranean world; recurrences over the next two centuries would kill more than 25 percent of the world's population. In the 14th century, another outbreak of plague, called the Black Death driven by fleas that live on rats but can bite humans claimed over 75 million lives, including some 60 percent of the population of Europe, whose cities were piled with reeking corpses. In the 16th and 17th centuries Native Americans were ravaged by smallpox and other diseases brought by European conquerors and colonists; in some areas as much as 90 percent of native populations were wiped out. The pandemic with the greatest number of casualties in history was the Spanish flu of 1918. It infected some 500 million people worldwide a third of the population and killed as many as 100 million.

This article was first published in the latest issue of The Week magazine. If you want to read more like it, try the magazine for a month here.

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The growing viral threat - The Week

Friday, February 28, 2020

As consumer interest in sustainable alternatives to fossil-based plastics continues to grow and food and beverage companies set goals to reduce their environmental footprint, the use of biobased plastics in food packaging is expanding. Revenue for the U.S. biobased plastics manufacturing sector was $177.9 million annually, according to a 2018 report prepared for U.S. Department of Agriculture (USDA), titled,An Economic Impact Analysis of the U.S. Biobased Products Industry.[1]The report also estimates a 4.5% grow rate for the sector over the five years from 2018 through 2023.

The total production volume of bio-based building blocks and polymers (worldwide) was 7.5 million tons in 2018, or about 2% of the production volume of petrochemical polymers, with a growth rate of 4% expected through 2023, according to a report by Nova-Institute GmbH.[2]The potential for significant growth is much higher, but low oil prices and a lack of political support are hampering growth, notes the report.

Examples of the use of biobased plastics in food packaging include Snickerscandy bars with a bio-based film wrapper made from potato starch by-products that were introduced by Mars in 2016 and the soon-to-be-available 20-ounce size Dansani water bottles made with up to 50% of renewable plant-based and recycled PET material beginning in mid-2020. The Coca-Cola Company first launched recyclable bottles made partially from plants (PlantBottle) in 2009 and expanded access to the PlantBottle IP in early 2019 to encourage industry-wide adoption. The new bottle, referred to as HybridBottle, includes recycled PET material in addition to the plant-based material.[3]

Other uses of biobased plastics in food contact articles include bags; containers for fruit, vegetables, eggs and meat; bottles for soft drinks and dairy products; flexible packaging; and coffee pods. Biobased plastics also have been used in food service ware, such as bowls, cups, and straws.

Like most materials that are intended to be used to package or otherwise in contact with food, biobased materials are also subject to the regulatory requirements imposed by several jurisdictions throughout the world. This article will focus on the requirements related to obtaining regulatory approval of biobased food contact materials (FCMs) in the U.S. and the European Union (EU), safety considerations, and future considerations.

Well begin with some definitions. Biobased means related to or based out of natural, renewable, or living sources. Biodegradable means capable of being broken down naturally to basic elemental components (water, biomass, and gas) with the aid of microorganisms. Compostable plastics are a subset of biodegradable plastics that biodegrade under specified conditions and timeframes.

Several international standards are available to determine compostability of plastic packaging. The European Committee for Standardization, standard EN 13432, Requirements for packaging recoverable through composting and biodegradation, is a harmonized European standard and is linked to the EU Directive on Packaging and Packaging Waste (94/62/EC). In the U.S., American Society for Testing and Materials standard ASTM 6400, Standard Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal of Industrial Facilities, is cited in various regulations. For example, California requires that food and beverage containers labeled as compostable must meet the ASTM D6400 standard.

An important distinction exists between biobased plastics and bioplastics. European Bioplastics defines bioplastics as a plastic material that is either biobased OR biodegradable OR both. On the other hand, biobased plastics are plastics manufactured from renewable biomass, such as vegetable oil, cornstarch, pea starch, and microbiota. Accordingly, a product can be both biobased and biodegradable, but it can also be biobased and not biodegradable, or biodegradable and not biobased.

Bio-based food contact materials (BBFCMs) are derived from biological renewable resources (animal or plant biomass) that consist of polymers directly extracted or removed from biomass, produced by chemical synthesis using renewable bio-based monomers, or produced by microorganisms or genetically modified bacteria, according to the 2019 report,Bio-Based Materials For Use In Food Contact Applications.[4]

The first bioplastics were developed from traditional agricultural resources, such as sugarcane, soy protein, starch, and cellulose. Within this group are polymers directly extracted from biomass and polymers produced by chemical synthesis using renewable biobased monomers. For example, polylactic acid (PLA), which is commonly used as a base material or coating in food packaging, is produced through the polymerization of lactic acid, which can be derived from the fermentation of agri-food wastes such as sugar beets or sugarcane.

PLA exhibits barrier properties comparable to fossil-based plastics, such as low-density polyethylene (PP) and polyethylene (PE), and has been used as a replacement for them, although it has the disadvantage of being more expensive to produce. The first generation of bioplastics also includes polymers produced by microorganisms or microbial fermentation, such as polyhydroxyalkanoate (PHA) and poly-3-hydroxybutyrate.

The second generation of bioplastics that are beginning to be introduced are made from raw materials such as food byproducts, wood, and sawdust, explained Patrick Krieger, Plastics Industry Association, in an interview for the 2018 USDA report mentioned above. He added that the next or third generation of bioplastics, many of which currently are in the laboratory stage, will come from algae and other organisms that are not associated with the production of food. Another area of research is the production of strains of microbes through genetic engineering that can improve yields of biobased polymers.

While biobased plastics offer a myriad of benefits related to sustainability, there are some concerns related to end-of-life issues. A potential disadvantage arising from the use of BBFCMs is the need to ensure effective segregation from fossil-based materials to enable their effective recycling, suggests Fera in the UK Report. For example, the presence of small quantities of PLA can prevent recycling of PET into a transparent product suitable for re-use in food and drink applications. Also, bioplastics produced from polymer blends that include biobased fillers may be difficult to recycle or may adversely affect the existing recycling stream.

Generally speaking, biobased plastics are required to comply with the same regulations with respect to food safety as fossil-based plastics.

In the U.S., the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301, et seq., provides that any substance, the intended use of which, is reasonably expected to become a component of food (e.g., migrates from packaging into food) must be authorized for such use by the U.S Food and Drug Administration (FDA) through a food additive regulation or in the case of packaging and other food contact materials, a Food Contact Notification (FCN), or the substance must be generally recognized as safe (GRAS), or used in accordance with a sanction or approval issued prior to 1958 by either the U FDA or USDA, among other potentially available exemptions and exclusions.

Polymers cleared for food-contact use through food additives petitions are listed in Title 21 of the Code of Federal Regulations (C.F.R.), Part 177, "Indirect Food Additives: Polymers." This part is further divided by types of polymers. Polymers and other food contact substances can also be cleared through an FCN. FCNs are proprietary and only may be relied on by the notifier/manufacturer and its customers.

For plastic packaging materials, FDA regulations generally clear the final polymer, not unreacted starting materials. There are, however, some exceptions where FDA permits certain starting reactants to be used to make a finished polymer. For example, in Part 175.300, "Resinous and polymeric coatings," FDA lists cleared precursor materials since these substances are typically complex and often cross-linked compounds.

In addition, any food-packaging material intended to come in contact with food must comply with FDA's Good Manufacturing Practices (GMP) regulation, found in Title 21 C.F.R. Section174.5. GMP requirements apply to both the use level of an additive as well as to its purity. This means that additives may only be used in an amount necessary to achieve their function or purpose and may not contain impurities at levels sufficiently high as to result in the adulteration of food.

In the EU, the Plastics Regulation, (EU) No. 10/2011, governs the use of plastic materials and articles intended to contact food. It applies to the plastic layers in all multilayer food-contact articles. This regulation includes a positive list of permissible monomers and other starting substances, additives (other than colorants), and some polymer production aids. In contrast to U.S. regulations, the EU Plastics Regulation does not include limits on co-reactants or use levels for starting materials, temperature restrictions, specification of single versus repeated use and food types for specific substances.

Anyone can petition to add a new monomer or additive to the Plastics Regulation's positive list. These petitions are first reviewed by the European Food Safety Authority (EFSA), which will issue a formal opinion on the safety of the substance when intended for use with food and any limitations that should be observed. Once EFSA has issued an opinion, finding a proposed use of a substance to be safe, the European Commission (EC), provided it concurs with the opinion, will add the substance to the list through an amendment to the regulation.

Finally, all FCMs in the EU must comply with the safety criteria set forth in Framework Regulation (EC) No. 1935/2004, which specifies that that food contact materials and articles may not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristic of the food. All food-contact materials must also comply with the Good Manufacturing Practice Regulation, (EC) No 2023/2006.

While certain biobased polymers have been cleared in the U.S. and the EU, such as PHA, there are a number of regulatory issues that need to be considered for new materials or new applications for existing materials. For example, when preparing a submission to obtain clearance of the material, what are the appropriate food simulants to be used to estimate the potential for migration? Likewise, how do you prove to authorities (and to customers) that the substance is stable for an intended application that involves a specific type of food or temperature range?

Also, in some instances, it may be necessary to demonstrate the suitable purity of product with respect to the potential presence of organic matter, such as cellular debris. Possible contamination with naturally produced contaminants (e.g., mycotoxins and algal biotoxins) may also need to be considered. Also, possible contamination with organic compounds (e.g., dioxins and polychlorinated phphenyls) or inorganic compounds (e.g., lead and arsenic), nitrates, pesticide and veterinary medicines residues, and plant toxins may need to be evaluated. In addition, depending on the feedstock and processing conditions, process contaminates such as acrylamide could be formed due to Maillard reactions occurring when complex biomaterials such as food are heated.

Additional questions could result from the inclusion of nanoscale materialsto improve barrier function and to achieve similar or better shelf lifein biobased packaging. There could also be questions about the genetically modified microbial strains, if they are used, to produce the biobased plastic. The UK Food Standards Agency (FSA) report points out that, to date, there have not been any studies that address the presence of genetically modified materials present in the biomass used for the production of BBFCMs.

Another regulatory consideration concerns the use of alternative fiber sources in biobased food packagingan area that is being investigated in both the U.S. and the EU. A potential application for fiber is the addition of bamboo to a polymer backbone for products such re-usable cups. Regulators in the EU are currently considering the use of bamboo in contact with food. With respect to other fiber sources, in the U.S., pulp is listed as generally recognized as safe (GRAS) under 21 C.F.R. Section186.1673 for food packaging uses, including paper production. It is defined as soft, spongy pith inside the stem of a plant such as wood, straw, sugarcane, or other natural plant sources, and therefore gives wide latitude in the potential candidates that could be available for use as alternative pulp sources. In the EU, untreated wood flour and fibers are cleared as additives in the Plastics Regulation. However, in all of these cases, the suitable purity/safety demand of the regulations are still applicable.

Conclusion

The report,Bio-Based Materials for Use In Food Contact Applications, was the result of a review commissioned by the FSA on potential risks and other unintended consequences of replacing fossil-based plastic food contact materials with BBFCMs. The key findings from the study are summarized below.

While the current use of BBFCMs is low, the UK report predicts that their use will grow significantly in response to consumer pressures, manufacturer demand, and increased levels of industrial production. Also contributing to the growth of biobased plastic are new regulations that encourage movement toward sustainable products, especially in the EU, and the development of biobased polymers with increased performance benefits, such as ones that can be used in lighter weight bottles that can hold carbonated pressure longer. Finally, increased demand for biobased products is likely to drive down production costs.

*This article is reprinted with the permission ofFood Safety magazine. It first appeared in theFebruary/March 2020 issue.

[1]The report is available at:https://www.biopreferred.gov/BPResources/files/BiobasedProductsEconomicAnalysis2018.pdf.

[2]See Nova-Institute GmbH press release at:http://news.bio-based.eu/2018-was-a-very-good-year-for-bio-based-polymers-several-additional-capacities-were-put-into-operation/.

[3]The Coca-Cola Company issued a press release on August 13, 2019, on the new HybridBottle, that can be found here:https://www.coca-colacompany.com/press-center/press-releases/dasani-takes-steps-to-reduce-plastic-waste.

[4]This report was prepared by Fera Science Limited (Fera) for the UK Food Standards Agency and is available here:https://www.food.gov.uk/sites/default/files/media/document/bio-based-materials-for-use-in-food-contact-applications.pdf.

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Biobased Plastics and the Sustainability Puzzle - The National Law Review

Rising at an impressive single digit CAGR, the global polymerase chain reaction market is predicted to attain a value of almost US$7.0 bn by 2026-end. Factors enabling the market to rise so impressively is the increasing research and development expenditure, gigantic strides made in the domain of pharmacogenomics, and rising trend of self-diagnosis of ailments. The global polymerase chain reaction (PCR) market is also being boosted by new technologies for diagnosis of cancer.

Further, research and development in advanced molecular biology, forensic science, and genetic engineering are also predicted to positively influence the global polymerase chain reaction (PCR) market. The only hurdle emergence of the alternative next-generation sequencing. The expensiveness of certain commercial PCR technologies is also dampening sales in the market to a degree.

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A few noticeable trends which key stakeholders in the global polymerase chain reaction (PCR) market need to keep in mind are as follows:

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Pharmaceutical & Biotechnology Industry Segment Held a Major Share of the Global PCR Market in 2017

The PCR technique has been found to be useful in pharmaceutical and biotechnology research activities as well as microbial quality testing. The technique is also applied in genetic engineering. Genetic engineering is the key driver for the global PCR market. It is used to identify genes related to certain phenotypes including genetic disorders. Regular testing of the microbial load of raw materials and finished products is an important process in the pharmaceutical & biotechnology industry. Sophisticated analytical methods such as polymerase chain reaction (PCR) have been widely applied for quality control analysis in the pharmaceutical sector.

Market in Asia Pacific to Expand at a High CAGR

Molecular diagnosis has revolutionized the modern diagnosis technology. PCR has become a method of choice in early and accurate detection of diseases. Expansion by leading manufacturers of PCR products in the Asia Pacific region by strengthening of the distribution network and new product launches in developing countries of Asia Pacific are key factors likely to drive the PCR market in the region during the forecast period.

Moreover, rise in the incidence of cancer and infectious diseases has resulted in increase in the demand for use of the PCR technique in clinical diagnosis of these diseases in Asia Pacific. For instance, according to the Korea Central Cancer Registry published in 2016, there were 217,057 cancer cases in South Korea in 2014. Moreover, in 2016, the WHO estimated that the Asia Pacific region has the second-highest number (i.e. 5.1 million) of people living with HIV across the world. Thus, Asia Pacific is expected to be the most lucrative market for PCR by 2026.

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Competition Landscape

Major players operating in the global PCR market are Bio-Rad Laboratories, Inc., QIAGEN N.V., F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc. Becton, Dickinson and Company, Abbott, Siemens Healthcare GmbH (Siemens AG), bioMrieux SA, Danaher Corporation, and Agilent Technologies. Key players are expanding their product portfolio through mergers and acquisitions and partnerships and collaborations with leading pharmaceutical and biotechnology companies and by offering technologically advanced products.

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Polymerase Chain Reaction (PCR) Market: Pharmaceutical & Biotechnology Industry Segment Held a Major Share of the Global Market - BioSpace

Red Carpet: check. Crowd of proud community members: check. Three young shining examples of leadership from the Boys & Girls Clubs: triple check.

On Tuesday night, the Boys & Girls Clubs of the Tar River Region recognized Nia Ewuell, Caleb Woodard and Elijah Sellars as finalists in the regional level of the Youth of the Year competition. Of these three, one also was selected as the winner and will receive a $1,000 scholarship and the chance to compete in the state level of the competition.

I want to tell these kids and remind everyone that the world needs contributions from everyone, said Ron Green, CEO of the club. Its not just his story or her story. Its our story.

The winner was announced at the end of the show. Leading up to the report, attendees were able to enjoy a step dance performance by a group in the club, listen to a speech by Green that rhymed impressively all the way through and talked about famous African-Americans such as Frederick Douglass and Serena Williams, sing along with Tobias Hopkins to U2s Lean On Me and watch in amazement as another young man from the club played an electric guitar along to Michael Jacksons Rock the Night Away.

Everyone was so excited to clap for him that he had to give a thumbs up for when he was done as small rounds of applause kept breaking out during the song.

The audience also heard from the three finalists. Prior to the event, contestants had been judged by six members of the community for things such as academic success, public speaking ability and demonstrated leadership within the club. A shopping trip for formal dress clothing was sponsored by Rocky Mount Toyota.

Woodward spoke first, dressed in a classy blue suit. He thanked the club for the love and time they had poured into him and talked about how, moving forward, he wanted to focus on addressing the growing obesity rate in youth.

Sellars, in a sharp burgundy suit and bow tie, brought a remarkable energy to the stage. His speech sounded as though it was a series of journal entries, all beginning with: Are you there, God? Its me, followed by discussion of a rough childhood involving topics such as drugs and an absent father, as well as the happiness he found in the Boys & Girls Clubs.

In a stylish pink blouse, black suit and heels, Ewuell spoke about how the club influenced who she has become, recognizing the empathy and acceptance she has learned and her plans to continue to develop those traits as she becomes a lawyer.

All three received a commemorative medal and a gift. Woodward was announced as third, leaving Sellars and Ewuell waiting at the front of the stage.

Green paused for a long moment, then finally announced: Of our two remaining, it couldve been either one. Tonight, our winner is Elijah Sellars.

As soon as Sellars was announced, he and Ewuell grabbed onto each other in a hug, with Woodward joining soon after. After several pictures with the oversized check and various members of the club, Sellars was able to approach the podium with his closing remarks, a grin stretched wide across his face.

To all of the kids from the Boys & Girls Club here today, and everyone else too, we are the future, but we are also the present, he said. Its up to us. I challenge each one of us to start shaping our own futures.

Sellars, a sophomore, hopes to one day attend either N.C. State University or Duke University to study genetic engineering. He plans to use the scholarship to help pay for his education, or, if expenses can be covered another way, use the money to invest in another youth of the year by sponsoring a shopping trip or another way to give back.

What I learned from the Boys & Girls Club is just how important it is to lean on one another, Sellars said. Im excited to represent kids Ive known my whole life, kids I know and love, in this competition. Im nervous about the next step, of course, but I know I have my clubs support.

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Area's Youth of the Year honored | Local News - Rocky Mount Telegram