Category Archives: Genetic Engineering

Two more cases of the new strain of coronavirus have been confirmed at the San Antonio military base where some evacuees from a cruise ship were quarantined Monday, the Centers of Disease Control and Prevention said at a press conference Friday. This brings the number of confirmed Texas cases of the strain named COVID-19 to three.

The two evacuees were among 329 Americans repatriated against the CDC's recommendation after disembarking from the Diamond Princess off of Japan. Another 16 cruise ship evacuees quarantined in California and Nebraska have also been confirmed to have coronavirus.

"[The passengers] are considered at high risk for infection, and we do expect to see additional confirmed cases of COVID-19 among the passengers," said Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, during the press conference.

There are also several Americans hospitalized in Japan who are "seriously ill," she said.

The first Texas case was confirmed Feb. 13 when one of 91 Americans evacuated from the Hubei province of China, the epicenter of the outbreak, was hospitalized. The remaining 90 Americans were released from the San Antonio base Thursday because they showed no symptoms after a 14-day quarantine.

The World Health Organization declared COVID-19 a public health emergency by last month. According to the latest CDC report, there are over 75,000 confirmed cases worldwide, and the death toll has surpassed 2,000. But outside of China, there have been only three fatalities, and none in the U.S.

The total number of confirmed U.S. cases is 34. However, the CDC makes a distinction between cases among repatriated Americans and all other U.S. cases, as the former aren't an accurate representation of how the virus is spreading within the country, according to Messonnier.

"We don't yet have a vaccine for this novel virus, nor do we have a medicine to treat it specifically," Messonnier said.

The goal now is to slow the introduction of the virus into the U.S. to buy time to prepare the community for more cases and possibly sustained spread, she added.

Two elderly Japanese passengers aboard the Diamond Princess died after testing positive for the virus, Japan's health minister said Thursday.

Researchers at the University of Texas at Austin are working on a vaccine, and a Houston-based genetic engineering company announced this week it finished developing one. However, the Food and Drug Administration has not yet approved a vaccine.

Disclosure: The University of Texas at Austin has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Texas coronavirus cases climb to three in San Antonio - The Texas Tribune

As Western culture becomes more and more secular, or to use Charles Taylors fascinating word disenchanted, traditions and practices once largely normal seem more and more strange. Large families, choosing church over Little League, or smudged foreheads just arent as normal as they used to be, and the second glances or raised eyebrows they create reveal more than a confusion about the thing itself.

In fact, Im not sure there is a Christian observance that more directly collides with the widely accepted values of secularism than the imposition of the ashes, a tradition that goes back about ten centuries and marks the beginning of the season of Lent on the Church calendar.

Like Advent, the season of Lent is about preparation. Before Christmas, our Christian forebears thought it wise to prepare a bit, and that by diving deeply into Old Testament promises and prophecies wed better understand the birth of Christ in the full context of redemptive history. So too, in Lent, our Christian forbears thought it wise to prepare for Holy week, especially for celebrating the resurrection on Easter Sunday.

A key distinction is that Lenten disciplines, beginning with Ash Wednesdays reminder that You are dust and to dust you shall return, place our celebration of resurrection in the context of our humanity, both our mortality and our fallenness. Even if the church calendar and its accompanying disciplines is not part of your church tradition, these two aspects of our humanity deserve our focused, intentional, and extended reflection.

Of course, most Christians would quickly reply that, of course, sin and death affect us all post-Eden. The problem is, in a secular culture, these beliefs that are crucial to a Christian worldview can be subtly secularized in our own hearts and minds.

Years ago, when my grandfather was dying, he suffered terribly for three or four months. In sorrow, I asked my pastor, Why doesnt God just take him? I expected him to say something along the lines of, Well, God has His ways, and His own timing, but instead he said something Ill never forget: Because your grandfather needs to know his mortality before he meets his maker.

What Ponce de Leon once sought in the waters of a Fountain of Youth, we still seek today via genetic engineering, eugenics, and other technologies. In other words, we seek control over this world and even over death itself.

Despite our search, death remains the universal problem of the human condition, one that afflicts us all. A secular culture is led by the reality of death to fear death itself, so that we either attempt to control death or distract ourselves from the thought of it. As a result, we learn to live life in light of the moment, rather than eternity.

The reality of death should, instead, remind us to fear God. That after death, we will meet the maker of life, is worth pondering, not just at the moment of death, but constantly throughout our lives.

Theologian Craig Gay warned in his book The Way of the Modern World that many of us who believe in God live as if God were largely irrelevant to most of life. The reminder of our mortality in the words, You are but dust and to dust you shall return, is a wonderful antidote for what he called practical atheism.

Just like with the idea of mortality,our understanding of our own sinfulness is also under threat of being secularized in our own minds. In a culture committed, in the name of freedom, to removing the categories of sin or guilt, one quick to give away nearly universal get-out-of-jail-free cards in the name of sexual freedom, too many Christians lose any abhorrence for that which ought shock and shame us.

Perhaps this is why the salvation brought by Christs life, death, and resurrection is so often described as a wonderful example of love and sacrifice or how to gain purpose and perspective, but so rarely in the terms of judicial forgiveness and cosmic victory that Paul and Peter and Jesus Himself so often used.

Being confronted with our own sinfulnessis certainly no fun, but God graciously does it. After all, the cruelest thing to tell someone whos not okay is that they are, as both secularized cultures and secularized churches too often do. Repentance is a gift, the only way forward for those on the edge of the moral abyss. Its proof that God is kind, the Scriptures say.

We just dont hear these things often enough. So, thank God for Lent.

Publication date: February 26, 2020

Photo courtesy: Ahna Ziegler/Unsplash

BreakPointis a program of the Colson Center for Christian Worldview. BreakPoint commentaries offer incisive content people can't find anywhere else; content that cuts through the fog of relativism and the news cycle with truth and compassion. Founded by Chuck Colson (1931 2012) in 1991 as a daily radio broadcast, BreakPoint provides a Christian perspective on today's news and trends. Today, you can get it in written and a variety of audio formats: on the web, the radio, or your favorite podcast app on the go.

John Stonestreet is President of the Colson Center for Christian Worldview, and radio host of BreakPoint, a daily national radio program providing thought-provoking commentaries on current events and life issues from a biblical worldview. John holds degrees from Trinity Evangelical Divinity School (IL) and Bryan College (TN),and is the co-author of Making Sense of Your World: A Biblical Worldview.

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You Are but Dust, and to Dust You Shall Return - Christianheadlines.com

Wei-Hua Shao,1 4,* Cheng-Yu Wang,4,5,* Lei-Yun Wang,1 4 Fan Xiao,1 4 De-Sheng Xiao,6 Hao Yang,4,5 Xue-Ying Long,7 Le Zhang,8 Heng-Gui Luo,9 Ji-Ye Yin,1 4 Wei Wu4,5

1Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, Peoples Republic of China; 2Institute of Clinical Pharmacology, Central South University; Hunan Key Laboratory of Pharmacogenetics, Changsha 410078, Peoples Republic of China; 3Engineering Research Center of Applied Technology of Pharmacogenomics, Ministry of Education, Changsha 410078, Peoples Republic of China; 4Department of Geratic Surgery, Xiangya Hospital, Central South University, Changsha, Hunan 410008, Peoples Republic of China; 5National Clinical Research Center for Geriatric Disorders, Changsha, Hunan 410008, Peoples Republic of China; 6Department of Pathology, Xiangya Hospital/School of Basic Medicine, Central South University, Changsha 410078, Hunan, Peoples Republic of China; 7Department of Radiology, Xiangya Hospital, Central South University, Changsha 410008, Peoples Republic of China; 8Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, Peoples Republic of China; 9Department of General Surgery, The Central Hospital of Xiangtan City, Xiangtan, Hunan, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Wei WuDepartment of Geratic Surgery, Xiangya Hospital, Central South University, Xiangya Road 87, Changsha 410008, Hunan, Peoples Republic of ChinaTel +86 731 89753053Email wwtw1972@126.com

Purpose: In order to clarify which variants of the MMR gene could provide current healthy members in affected families a more accurate risk assessment or predictive testing.Patients and Methods: One family, which meets the criteria according to both Amsterdam I/II and Bethesda guidelines, is reported in this study. The proband and some relatives of the patient have been investigated for whole genome sequencing, microsatellite instability, immunohistochemical MMR protein staining and verified by Sanger sequencing.Results: A heterozygous insertion of uncertain significance (c.420dup, p.Met141Tyrfs) in MSH2 gene was found in proband (III-16) and part of His relatives. The variant was associated with a lack of expression of MSH2 protein (MMR deficient) and high microsatellite instability analysis (MSI) status in tumor tissues of LS patients. In addition, we found that the variant could affect the expression of MSH2 and the response to chemotherapy drugs in vitro.Conclusion: We identified an insertion mutation (rs1114167810, c.420dup, p.Met141Tyrfs) in MSH2 in LS using whole genome-wide sequencing (WGS). We further confirmed that this mutation plays an important role in LS patients of this pedigree based on in vivo and vitro study.

Keywords: Lynch syndrome, genetic variation, mismatch repair gene, MSH2, chemotherapy resistance

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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A Hereditable Mutation of MSH2 Gene Associated with Lynch Syndrome in | CMAR - Dove Medical Press

DUBLIN--(BUSINESS WIRE)--The "Protein Sequencing Market by Product and Service Technology and Application: Global Opportunity Analysis and Industry Forecast, 2019-2026" report has been added to ResearchAndMarkets.com's offering.

The global protein sequencing market size was valued at $ 5,399.9 million in 2018 and is expected to reach $ 9,926.7 million by 2026, registering a CAGR of 7.8% from 2019 to 2026.

Protein sequencing provides information regarding the amino acids that make up a protein. While performing the sequencing process, amino acids are sequentially removed from the N-terminal end of the protein strand and identified in the order they occur in the protein. Protein sequencing finds its wide applications in the field of genetic engineering, and biotherapeutics. There are two main technologies available for protein sequencing namely Edman degradation and mass spectrometry. Edman degradation is considered as the gold standard for protein sequencing.

The major factors contributing to the growth of the protein sequencing market include surge in focus on biotherapeutics development biotechnology and pharmaceutical companies in various developing and developed regions. Technological advancements in de novo peptide-sequencing methods and analytical methods, with the application of neural networks, have opened new avenues in the market. However, high cost of infrastructures and the required equipment such as mass spectrometers, hamper the market growth. On the contrary, technological advancements for the identification of isobaric residues in protein sequences are expected to create lucrative opportunities in the near future.

KEY BENEFITS FOR STAKEHOLDERS

Key Findings of the Protein Sequencing Market:

Key Topics Covered:

Chapter 1: Introduction

1.1. Report Description

1.2. Key Benefits For Stakeholders

1.3. Research Methodology

1.3.1. Secondary Research

1.3.2. Primary Research

1.3.3. Analyst Tools & Models

Chapter 2: Executive Summary

2.1. CXO Perspective

Chapter 3: Market Overview

3.1. Market Definition And Scope

3.2. Porter's Five Forces Analysis

3.3. Market Share Analysis

3.4. Market Dynamics

3.4.1. Drivers

3.4.1.1. Increasing Focus On Target-Based Drug Development

3.4.1.2. Advancements In Mass Spectrometry And Analytical Techniques

3.4.2. Restraints

3.4.2.1. Dearth Of Skilled Researchers And Laboratory Professionals

3.4.3. Opportunities

3.4.3.1. Opportunity In Computational Proteomics

Chapter 4: Protein Sequencing Market, By Products & Services

4.1. Overview

4.2. Reagents & Consumables

4.3. Instruments

4.4. Analysis Product

4.5. Protein Sequencing Services

Chapter 5: Protein Sequencing Market, By Technology

5.1. Overview

5.2. Mass Spectrometry

5.3. Edman Degradation

Chapter 6: Protein Sequencing Market, By Application

6.1. Overview

6.2. Biopharmaceuticals

6.3. Biotechnology Research

Chapter 7: Protein Sequencing Market By Region

7.1. Overview

7.2. North America

7.3. Europe

7.4. Asia-Pacific

7.5. LAMEA

Chapter 8: Company Profiles

8.1. Charles River Laboratories

8.2. Shimadzu Corp.

8.3. Agilent Technologies

8.4. Thermo Fischer Inc.

8.5. Selvita

8.6. Rapid Novor.

8.7. Sgs

8.8. Proteome Factory

8.9. Bioinformatics Solution

8.10. Water Corporation

For more information about this report visit https://www.researchandmarkets.com/r/tahl8q

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Global Protein Sequencing Market Drivers, Restraints & Opportunities During the Forecast Period, 2019-2026 - ResearchAndMarkets.com - Business...

With Calyxt making fried foods healthier, maybe celebs will actually eat them instead of just posing with them. Rich Polk/Getty Images for The Weinstein Company

Eat up, America. Your favorite standby comfort foodthose slightly greasy, salted-just-right French fries that have thrown many a dieter off the straight and narroware now healthy. Or at least healthier than they ever have been, thanks to food-tech disruptor Calyxt (pronounced Kay-Lix with an aspirated t at the end) and its breakout vegetable oil, which is designed with less saturated fat and more healthy oleic acid than typical unmodified frying oils.

I first stumbled across Calyxts healthy frying oil at the most unlikely of places: the Minnesota State Fair,a 320-acre mecca of unhealthy eating, butter sculptures, live farm animal births and other assorted curiosities.

SEE ALSO: How Blue Apron Became a Massive $2 Billion Disaster

Any good Minnesotan worth his weight in walleye, even those of us like me who have lived all over the world, will always make a point to come back to our native Land of 10,000 Lakes in late August, in part so we can take in one of the states few months of non-sub-zero temperatures, but also because the second half of August is precisely when we can visit the two-week affair known among locals as the The Great Minnesota Get-Together. Its the largest of its kind in the country, and last years attendance drew in over two million visitors, meaning over a third of all Minnesotans took a day out of their lives to join in on the perennial celebration.

At last years gathering, word was spreading quickly that the Ball Park Caf, a long-time state fair staple, known for its famous beer selection, burgers and garlic fries, had switched to Calyxts healthier vegetable oil for all of its frying needs. Given that the fair happened to fall just as I was several weeks into one of my many concerted efforts to finally get back in shape, I was intrigued.

I was expecting the fries I ordered to taste somehow artificial or rubbery, as do many healthy versions of other foods, but the flavor and consistency of the Calyxt-fried Freedom Fries was exactly as one might expect from a normal bath of hot oilcrispy and yummy. Decadence never tasted so good.

Several weeks after the fair, I looked up the company behind this healthy oil and scheduled a meeting with Calyxts communications head, Trina Lundblad and company CEO Jim Blome. We decided to meet at their offices, a sleek, ultra-modern building in a Minneapolis suburb, overlooking a large swath of prairie grass and pristine crop rows.

The Calyxt headquarters have a definite Silicon Valley feel. Were not an ag company; were a tech company that is applying its IP to the ag sector, said company spokeswoman and communications head Trina Lundblad. Courtesy of Calyxt

For the next several hours that I spent touring the Calyxt headquarters, I came to realize that I was not just visiting, contrary to my expectations going in, another food-based CPG company simply riding the wave of a popular new frying oil with a healthy twistI was at ground zero of the tech revolution in agriculture, where genome editing is revolutionizing the nutritional attributes of the foods we, as humans, will need to continue as a species in the years and centuries to come.

If that sounds like a big deal, its because it is.

Calyxt describes its oil, the product of an improved soybean plant, as having the heart-healthy fat profile of olive oil without the distinctively earthy aftertaste that is fine for spaghetti, but less so for waffles or fried chicken. By using a breakthrough gene-editing technology, Calyxt is engineering an entirely new set of processes for improving the genetic profile for many staples of the nutritional supply chain without introducing transgenic, foreign properties into the mix; Calyxts technology stands out in that it is simply accelerating and improving upon what nature would have probably gotten around to eventually on its own, only several millennia later.

Importantly, the process used by Calyxt, which relies on DNA-cutting enzymes that thankfully go by the abbreviation TALEN (transcription activator-like effector nuclease), sidesteps much of the public and regulatory outcry often associated with traditional GMOs (genetically modified organisms), in which an organisms genetic makeup has been modified in a laboratory using transgenic technology that combines, in a sort of Frankenstein-esque way, plant, animal, bacterial and virus genes that do not occur in nature or through traditional crossbreeding methods.

Calyx, which is a publicly-traded company on the NASDAQ, is improving upon the farm to table fever, by starting upstream.

Way upstream.

Calyxts unique engineering process begins in the high-tech labs on the top floor of the companys headquarters, where a team of scientists reconfigure gene molecules on large computer monitor screens before instructing robotically controlled laboratory pipettes to do their thing. Later, embryonic plant cells are transferred to petri dishes that deliver the customized TALENs, which are then bathed in stimulating hormones and left to grow until they become big enough to see if the edits made upstream in the top floor lab were successful.

Plants that meet the designer teams original specs get pampered in high-tech temperature-regulated nurseries before later graduating to a greenhouse or to the small outdoors plot trials that abut the Calyxt headquarters. From the top performing plants, Calyxt begins developing seed banks that will eventually be sold to farmers.

But that is only the beginning. Its here, at this leg of the business, where Calyxt is positioning itself for long-term, paradigm shifting growth at the crossroads of technology and agriculture.

Jim Blome, the CEO of Calyxt, grew up in a family farm in central Iowa. Today, he leads a company that is playing a major role in defining the future of food on a global scale. Courtesy of Calyxt

Unlike most biotech companies that play in the broader competitive landscape of gene-editing, Calyxt is unique in that it is vertically integrating, contracting with farmers across the Midwest to grow its gene-edited, high oleic soybeans. Earlier this month, the company achieved an important milestone, having successively contracted 100,000 soybean acres with U.S. farmers, more than doubling the size of its planted acres from the previous year. Calyxt CEO Jim Blome lauded the achievement stating that 100,000 contracted acres will support market demand for our high oleic soybean oil.

Calyxts scientists design gene-editing molecules on computer screens, then use robots to build them using a set of DNA-cutting enzymes called TALENs, which are later transferred to petri dishes for analysis. Courtesy of Calyxt

After the growing season, just a few weeks after the Minnesota State Fair wraps up, Calyxt exercises its contracts to buy back the beans from the farmers at a premium to market prices and crushes them to make its healthy, french fry-friendly oil, which it is currently shipping across the country to food services companies and restaurant chains.

Farmers love the higher-than-market commodities prices Calyxt agrees to pay them. The food services sector loves the healthy aspects of the Calyxt end-product, which also has a reuse rate far more efficient than other oils on the market. And Calyxt loves sitting in the middle of both the supply and distribution chains.

I have spent my life in agriculture, and there is nothing as revolutionary happening around genome editing as what we are doing at Calyxt, added Blome, who previously served as the president and CEO of the North American Crop Science division of Bayer, the German multinational pharmaceutical and life sciences juggernaut. We are developing a foundation for the future of global agriculture through precision plant breeding and advanced analytical tools to solve complex challenges with system-based approaches. Tillable land is growing increasingly scarce, populations are growing and the earth is warming, and frankly, we arent ready for what this will mean even five or 10 years down the road.

What we are doing at Calyxt is harnessing the technology that will enable the entire global nutritional and industrial supply chain to adapt to these seismic changes underfoot. And were doing it in a responsible, ethical manner, that brings new opportunities to U.S. farmers, added Blome.

The Calyxt chief isnt simply talking about healthier frying oils, there is a much, much bigger play in the offing: Calyxts technology can be harnessed to address some of the most pressing concerns across all of food and nutritionfrom removing the allergens from nuts and peanuts, to designing better cereal plants, such as wheat, that not only deliver better yields but also address common allergies and afflictions like gluten intolerance. Tubers, tree fruits, CBD productsthe list of potential applications for Calyxt genome-editing is nearly endless.

Where high-tech meets agriculture. Calyxt researchers and plant scientists use state-of-the-art aeroponics growing facilities to iterate on plant-based genome editing. Courtesy of Calyxt

Chris Neugent, a veteran food marketer and former CEO of Post Consumer Brands, the maker of everything from Oreo Os to Grape-Nuts, sits on the board of Calyxt, bringing mission-critical consumer marketing and story-telling gravitas to a company known best for its high-tech bioengineering.

If the Calyxt story was a book, then you could say we are still in the first chapter, probably still on page one. Our work with smarter, healthier soybean oilsas groundbreaking as it isis still proof of concept. As we scale our business and begin adding more products, the market will begin to see us not as the healthier french fry guys but as a company that is revolutionizing next-generation nutrition in agriculture, observed Neugent. We are literally laying track for the biggest agricultural revolution since the transformation of human societies from hunting and gathering to farming. Its that big.

This Second Agricultural Revolution Neugent is alluding to envisages a not-so-far-off future in which Calyxt is redesigning crops to better withstand the massive changes underfoot caused by global warming, over-population and other seismic shifts affecting the future of food.

A young soybean plant flowers inside the Calyxt high-tech laboratory facilty. Courtesy of Calyxt

Like any industry that is shaking up the status quo, Calyxt is beginning to encounter its share of crosscurrents. So far, at least, U.S. regulators seem to be of the opinion that as long as Calyxt is making genetic alterations that could have conceivably occurred naturally, as opposed to other transgenic techniques used in GMOs, no special regulation is needed.

Other incumbent seed engineering companies have dabbled in the high oleic soybean space, but for the most part, they have come at the challenge through a more conventional gene-editing approach, which mixes in organisms that do not naturally conjoin outside of a laboratory, necessitating additional layers of regulatory safeguards.

Calyxt is using high-tech genome editing to serve up healthier versions of the same delicious plant-based foods that we have eaten for decades. Courtesy of Calyxt

For now, Calyxts approach doesnt require any additional oversight or specific product labeling, nor do company executives feel that any will be required at any point in the foreseeable future. The 2018 USDA-released GMO labeling requirements defines bioengineered foods as those containing detectable genetic material that has been modified through lab techniques that cannot be created through conventional breeding or found in nature. As a result, Calyxt is not subject to any additional regulatory or labeling requirements, which is allowing the company to forge ahead on multiple fronts. The company is already engaged in early experimentation with genome edited wheat plants, and it has scores of other applications in development.

For now, Calyxt is a still a small company, but one poised to make a big impact on the global food market.

However, for most of usat least those of us that just like to be able eat French fries from time to time and not feel too bad about it the next dayCalyxt is performing an equally important service on par with helping prepare global food sourcing for the impacts of climate change; they are giving us peace of mind the next time we hit the state fair, or anywhere else where Calyxt-fried French fries are being served.

See more here:
Healthy-ish French Fries Are Now a Thing Thanks to Genetic Redesigning - Observer

The bioindustry will require more cell and gene therapy plants, says an expert, who says the facilities of the future must be automated, scalable, and flexible.

The number of cell and gene therapies entering clinical development has increased significantly in recent years. According to the Alliance for Regenerative Medicines (ARM) there are 1,066 such therapies in trials at present1, which is a 32% increase on the number of studies in 2014. But the surge in clinical activity has not been matched by an increase in production capacity says Darren Dasburg, a cell and gene therapy-focused consultant.

Hundreds of facilities will be needed to manufacture the treatments that are in play now, he said, adding that if you factor in the plants needed to make viral vectors that could exceed a thousand facilities.

The good news, Dasburg says, is that these facilities are more like labs than traditional large biopharmaceutical plants.

Viral vector capacity is critical to the cell and gene therapy sector. Vectors are hollow viruses used to insert genetic material into cells, both cells used in protein expression and cells used therapeutically. Various organisations have voiced concerns about industry capacity to make vectors. In 2018, for example, the Alliance for Advanced Biomedical Engineering said the scarcity of viral vectors could hamper expansion2. Since then the situation has improved, but it has not been resolved3. While viral vector production capacity in the contract services sector has increased, the expansion is still falling short of demand.

Partly this is because of the complexity of making the vectors, according to Dasburg.

Most viral vectors are produced using adherent manufacturing technologies which are expensive to operate, he explains. A vial of just 20 million cells can cost $2030K because it is so challenging to make.

To bring down costs, vector capacity still needs to increase, continues Dasburg, who predicted that biopharma will continue to rely on CDMOs for the foreseeable future.

Cell and gene therapy manufacturing is still a young industry. Biopharma is still figuring out what the ideal production facility should look like.

Building for flexibility and multipurpose manufacturing is important, Dasburg says, noting that explaining CDMOs and IP holders need to understand they are attacking rare genetic diseases and ailments where the therapy might be a third-line treatment. The numbers are often quite lower, and the treatments can be one and done. All meaning the companies of the future will be attacking many more areas of need.

In terms of technology, all cell and gene therapy facilities should feature sufficient isolator capacity, Dasburg says. Isolators are probably the number one investment to make. Too many people are trying to work five people in full dress in a small room attempting to manufacture in a hands-on traditional way when isolation and automation could help immensely.

Dasburg pointed to benchtop platforms capable of processing a single CAR-T patients treatment as an example of an innovative approach being used. These can be arranged in an array within a single ballroom-like facility providing 100% containment going from leukapheresis bag to treatment bag without any human intervention.

References1. alliancerm.org/wp-content/uploads/2020/02/CBX-Meeting-7-Feb-2020-FINAL.pdf2. aabme.asme.org/posts/virus-shortage-for-cell-therapies-creates-engineering-opportunity3. http://www.genengnews.com/insights/gene-therapy-dollar-is-waiting-on-viral-vector-dime/

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More Cell and Gene Therapy Facilities in the Hundreds are Needed - Genetic Engineering & Biotechnology News

The Food and Drug Administration, facing increased criticism of its regulatory process for gene-edited animals, is mounting a new effort to defend its policies to farmers, researchers and developers, but the industry is backing the Agriculture Department's push to take over some of FDA's oversight role.

FDA regulates as animal drugs any intentional genomic alterations in animals, achieved through gene editing or older genetic engineering technologies,a position roundly criticized by the animal ag and biotechnology industries. The subject has gained more attention recently with statements from FDA defending its oversight role as necessary both for the safety of animals and humans.

We havent announced most of them yet, but were going to have a series of meetings, said Laura Epstein, senior policy adviser in FDAs Center for Veterinary Medicine. FDAs presentations will include case studies examining hypothetical products.

One of the primary goals of the presentations will be to explain the process and FDAs regulatory intentions to farmers, an audience FDA acknowledges it has not communicated with very much, Epstein said.

As a result, theres a lot of confusion and misinformation out there about what we plan on doing, she said. We got word back that farmers seemed to think were going to require them to register them as drug manufacturers. We want to assure them thats absolutely not the case.

One meeting FDA will definitely be attending is the Large Animal Genetic Engineering Summit in Utah in June, said Heather Lombardi, director of FDAs Division of Animal Bioengineering and Cellular Therapies.

FDAs effort follows publication of a commentary in Nature Biotechnology by Steven Solomon, director of FDAs Center for Veterinary Medicine, asserting the importance of regulatory oversight of intentional genomic alterations in animals, even when the intended modification seeks to replicate a naturally occurring mutation.

Solomons piece accompanied an FDA analysis on how the agency was able to detect unintended alterations in genome-edited bulls, Solomon said in a statement on FDAs website.

The biotech and conventional animal ag industries have been pushing for years to get FDA to loosen its regulatory reins, arguing that FDAs development of disease-resistant animals, for example, has been unduly delayed.

Agriculture Secretary Sonny Perdue made that point at USDAs Agricultural Outlook Forum last week, stating at a press conference that USDA is "in the process of working with FDA currently to help divide up the responsibilities, hopefully with an agreeable type of consensual memorandum of understanding with the agency over new breeding techniques. Perdue said FDA could handle oversight of food animal breeding, with FDA handling any other animals.

He pointed to the example of the nearly year-old agreement between USDA and FDA on cell-cultured technology, used to create meat that has been described as clean by supporters and fake by its opponents.

Under that agreement, the agencies said FDA would handle cell collection, cell banks, and cell growth and differentiation, with the Food Safety and Inspection Service overseeing the production and labeling of human food products derived from the cells of livestock and poultry.

Ag Secretary Sonny Perdue and FDA Commissioner Stephen Hahn meet in Perdue's USDA's office.

Without an easier path to commercialization, new breeding techniques are going to go to Argentina, Brazil, Canada, China, or other countries, Perdue said, making the U.S. a follower rather than a leader in the new technologies.

Representatives of both USDA and FDA were reluctant to discuss the interagency communications. A USDA spokesperson said only, We are always in discussion with various FDA officials on a number of issues dealing with American agriculture. FDAsaid the agency "continues to engagewith our federal partners in the regulation of agriculture biotechnology products.

Referring to USDA and EPA, its other participants in the governments effort to modernize biotech regulations, FDA said each agency has a role to play within its existing statutory structure.

USDAs Flickr account shows Perdue did meet with new FDA Commissioner Stephen Hahn only nine days before his appearance at Ag Outlook, along with Anna Abram, FDAs deputy commissioner for policy, legislation and international affairs, and Frank Yiannas, FDAs deputy commissioner for food policy and response.

The description on the Flickr site doesnt say what they talked about, but one longtime observer and participant in the animal biotech space said, I would be shocked if they had not discussed the issue. The meeting came two days after publication of Solomons commentary and the release of a statement from Hahn touting the potential of gene-editing technology for animals.

It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness, Hahn said.

The Center for Food Safety agrees. The FDA has scientists that better understand genetic engineering of animals given that it has been working for more than 20 years on both GE animals for research purposes and drug testing, and now GE animals for food, CFS Policy Director Jaydee Hanson said.

USDA, he said, has refused to develop regulations for its review of GE animals and insects, despite having agreed to do so in 2011 after a review by its own inspector general.

Perdues suggestion of an MOU was welcome news to the biotech community. Dana OBrien, the Biotechnology Innovation Organizations executive vice president of food and agriculture, called Perdues words encouraging. In an opinion piece posted on Agri-Pulses site Feb. 12, OBrien said BIO had shown the White House how the President could move animal biotechnology oversight to USDA an approach championed by key livestock and scientific stakeholders.

Im all for it, Acceligen CEO Tad Sonstegard saidof Perdues remarks supporting a division of responsibilities. Acceligen is a subsidiary of Recombinetics, which uses gene editing to develop animals for the agriculture and biomedical markets.

I agree with what BIO said, Sonstegard said. We need to get FDA to come to the table.

Jack Bobo, a food industry consultant who is a former vice president at biotech company Intrexon, said Perdues statement may lead to things moving a little more quickly on the animal biotech front. However, he added, Its not clear to me that this is a detailed proposal.

Intrexon owns Aquabounty, developer of genetically engineered salmon that was approved by FDA in 2015 after a 20-year process the only GE animal to be approved thus far. Sold in Canada since 2017, the fish will be available commercially in the U.S. later this, year according to Aquabounty.

Their record stands for itself one approval, Sonstegard said.

But FDA wants to improve its process. It is touting its Veterinary Innovation Program, which Hahn said encourages development and research and supporting an efficient and predictable pathway to approval.

The latest developments on the animal biotech front were triggered by FDAs publication of a paper detailing its discovery of unintended alterations in the progeny of a gene-edited, hornless bull. That paper was published in Nature Biotechnology the same day as the commentary by FDAs Solomon.

The bull was developed by Recombinetics and its calves were monitored by Alison Van Eenennaam, who runs the Animal Genomics and Biotechnology Laboratory at UC-Davis.

Alison Van Eenennaam, UC-Davis

Van Eenennaam responded to the FDA paper and commentary by saying she was "disappointed that the FDA failed to mention that the genome-edited bulls and their offspring were followed for years by researchers at UC Davis and were hornless (polled) and healthy.

The unintended alteration, a plasmid, was not transmitted to half of the offspring, so in one generation there were animals with just the targeted edit, she said, then wondered why her explanation of the project, also published in Nature Biotechnologyback in October, was not referred to in FDAs analysis.

Alexis Norris, a bioinformatician in FDAs Division of Animal Bioengineering and Cellular Therapies, said there was no deliberate attempt to ignore Van Eenennaams paper. FDA submitted its paper to Nature Biotechnology before hers was released, she said. Hers was in revision when ours was submitted to Bio. It was just a timing issue.

Van Eenennaam has been critical of FDAs process. There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food, she wrote on the Nature Research Bioengineering Community blog in a piece entitled Responsible Science Takes Time.

"It's just DNA, man," said Sonstegard.We eat it in every food except vegetable oil.

For more news, go to http://www.Agri-Pulse.com

See the article here:
FDA on mission to explain its animal biotech approval process - Agri-Pulse

The "Gene Therapy Market by Vector Type, Gene Type and Application: Global Opportunity Analysis and Industry Forecast, 2019-2026" report has been added to ResearchAndMarkets.com's offering.

The global gene therapy market was valued at $393.35 million in 2018, and is estimated to reach $6,205.85 million by 2026, registering a CAGR of 34.8% from 2019 to 2026.

Gene therapy is a technique that involves the delivery of nucleic acid polymers into a patient's cells as a drug to treat diseases. It fixes a genetic problem at its source. The process involves modifying the protein either to change the genetic expression or to correct a mutation. The emergence of this technology meets the rise in needs for better diagnostics and targeted therapy tools. For instance, genetic engineering can be used to modify physical appearance, metabolism, physical capabilities, and mental abilities such as memory and intelligence. In addition, it is also used for infertility treatment. Gene therapy offers a ray of hope for patients, who either have no treatment options or show no benefits with drugs currently available. The ongoing success has strongly supported upcoming researches and has carved ways for enhancement of gene therapy.

Recently, a new technique has been developed, where new genes are introduced into the body to help fight against cancer cells. Gene therapies are regarded as a potential revolution in the health sciences and pharmaceutical fields. The number of clinical trials investigating gene therapies is on an increase, despite the limited number of products that have successfully reached the market. In addition, benefits of gene therapy over conventional cancer therapies and increase in government support fuel the growth of the gene therapy market.

The gene therapy market is a widely expanding field in the pharmaceutical industry with new opportunities. This has piqued the interests of venture capitalists to explore this market and its commercial potential. Major factors that drive the growth of this market include high demands for DNA vaccines to treat genetic diseases, targeted drug delivery, and high incidence of genetic disorders. However, the stringent regulatory approval process for gene therapy and the high costs of gene therapy drugs are expected to hinder the growth of the market. On the contrary, increase in the pipeline developments for gene therapy market are expected to provide lucrative opportunity during the forecast period.

Key MARKET BENEFITS FOR STAKEHOLDERS

Key Findings of the Gene Therapy Market:

Key Topics Covered:

Chapter 1: Introduction

1.1. Report Description

1.2. Key Benefits

1.3. Key Market Segments

1.4. Research Methodology

Chapter 2: Executive Summary

2.1. CXO Perspective

Chapter 3: Market Overview

3.1. Market Definition And Scope

3.2. Key Findings

3.3. Top Player Positioning, 2018

3.4. Porter's Five Forces Analysis

3.5. Market Dynamics

Chapter 4: Gene Therapy Market, By Vector Type

4.1. Overview

4.2. Viral Vectors

4.3. Non-Viral Techniques

Chapter 5: Gene Therapy Market, By Gene Type

5.1. Overview

5.2. Antigen

5.3. Cytokine

5.4. Tumor Suppressor

5.5. Suicide Gene

5.6. Deficiency

5.7. Growth Factors

5.8. Receptors

5.9. Others

Chapter 6: Gene Therapy Market, By Application

6.1. Overview

6.2. Oncological Disorders

6.3. Rare Diseases

6.4. Cardiovascular Diseases

6.5. Neurological Disorders

6.6. Infectious Diseases

6.7. Other Diseases

Chapter 7: Gene Therapy Market, By Region

7.1. Overview

7.2. North America

7.3. Europe

7.4. Asia-Pacific

7.5. LAMEA

Chapter 8: Company Profile

8.1. Adaptimmune Therapeutics Plc.

8.2. Anchiano Therapeutics Ltd.

8.3. Achieve Life Sciences, Inc.

8.4. Adverum Biotechnologies, Inc.

8.5. Abeona Therapeutics Inc.

8.6. Applied Genetic Technologies Corporation

8.7. Arbutus Biopharma Corporation

8.8. Audentes Therapeutics Inc.

8.9. Avexis Inc.

8.10. Bluebird Bio, Inc.

8.11. Celgene Corporation

8.12. Crispr Therapeutics Ag

8.13. Editas Medicine, Inc.

8.14. Gilead Sciences, Inc.

8.15. Glaxosmithkline Plc

8.16. Intellia Therapeutics Inc.

8.17. Merck & Co., Inc.

8.18. Novartis Ag

8.19. Regenxbio, Inc.

8.20. Spark Therapeutics, Inc.

8.21. Sangamo Therapeutics, Inc.

8.22. Uniqure N. V.

8.23. Voyager Therapeutics, Inc.

For more information about this report visit https://www.researchandmarkets.com/r/yt2y68

View source version on businesswire.com: https://www.businesswire.com/news/home/20200225005742/en/

Contacts

ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.com For E.S.T. Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

Original post:
Global Gene Therapy Market Projected to Grow with a CAGR of 34.8% During the Forecast Period, 2019-2026 - ResearchAndMarkets.com - Yahoo Finance

New pet food companies are springing up to meet what they say is growing demand for plant-based, sustainable alternatives to Fancy Feast and Kibbles N Bits.

By making products from fermented fungus and experimenting with lab-grown food from animal cells and microbes, alternative pet food makers are hoping to carve out a share of the $30 billion U.S. pet food market.

And multibillion-dollar pet food companies, like Mars Petcare and Nestl-owned Purina, are starting to take notice.

Our mission is almost the exact same as Impossible Foods, which is [to] reduce or eliminate factory farming, which has this giant environmental footprint, said Josh Errett, CFO of Because Animals, one of the companies developing new pet foods. I mean, calling it a footprint is too nice, its an environmental disaster.

The other mission is to make a profit. These companies are catering to pet owners who value their ecological footprint and have the income to pay for an alternative product that tends to be more expensive than a can of Pedigree.

Pulling away from factory farming

A UCLA study from 2017 by Professor Gregory Okin estimated that dog and cat food accounts for the release of millions of tons of the greenhouse gases methane and CO2 and constitutes about 25%30% of the environmental impacts from animal production in terms of the use of land, water, fossil fuel, phosphate and biocides.

Like plant-based market leaders Impossible Foods and Beyond Meat, alternative pet food companies say their product will reduce the amount of land and energy used for conventional meat production.

Industrial animal farming, or concentrated animal feed operations, produce large amounts of byproducts and off-cuts like organs and bone meal which are not usually used in human food, but are re-purposed for pet food production.

The goal is to cut factory farming out of the supply chain completely without a market for the unused parts, the meat industry would collapse due to lost revenue, Errett said.

But many large pet food companies defend their use of animal byproducts.

One might argue that this is actually a super sustainable source, because were using materials that most of us wouldnt consume and would be wasted, said Richard Butterwick, global nutrition advisor at the Waltham Petcare Science Institute, a research center for Mars Petcare.

Because Animals along with another company, Wild Earth are using cellular technology to culture real meat from animal cells biopsied from living creatures. The cells are encouraged to proliferate and reproduce in a bioreactor, creating muscle protein without the need to slaughter animals. This process is also being used by more than 30 companies worldwide to develop clean or lab-grown meat for human consumption.

Next year, both Because Animals and Wild Earth hope to release their first cell-grown cat foods, made of cultured mouse meat.

Were getting back to what the cats system was built to digest, Errett said. You dont have to add taurine or anything back, you can make an ancestral diet.

A cat owner himself, Errett wanted to address the ultra-processed nature of a lot of the conventional cat food, or as he calls it biological waste. Cats are obligate carnivores, meaning they need to eat meat to get the 11 essential amino acids they require or they could have serious health problems like blindness or even death.

By culturing animal meat in a lab, these companies can genetically control what nutrients present in the food. They can also eliminate potentially dangerous substances that have made their way into some conventional pet foods. Some popular pet foods companies have had to recall their products in recent years due to toxic levels of Vitamin D and even the euthanasia drug sodium pentobarbital.

Will pet owners buy lab-grown mouse meat for their cats?

Beyond Meat increased its revenues by 250% between 2018 and 2019; consumers are taking an interest in the health and environmental benefits promoted by plant-based foods. Pet owners are showing that they will pay more for luxury and premium pet foods.

Wild Earth is making dog food from cultured fungi proteins and, according to CEO Ryan Bethencourt, revenue is growing steadily even though production is still relatively small.

This plant-based type of cultured pet food, already on the market, is much more expensive than the conventional options. A 18-pound bag of Wild Earth dog food sells for $49 on its website; whereas the website Chewy sells a 18.5-pound bag of Purina Dog Chow for $11.99.

Bethencourt said the potential for cultured protein could be 10% of the total pet food market within the next 10 years. He is using the success of plant-based proteins for humans as evidence for the market potential of alternative pet foods.

Research backs his point; according to one study from 2019, it is clear that an association exists between the diet a pet owner has chosen to follow and the diet they choose to feed their pet.

Culturing microbes into pet food

Another alternative pet food company, Bond Pet Foods, is taking a slightly different approach to cultured pet food. Bond is experimenting with genetically engineering microbes, like yeast.

Theres a lot more that isnt known about growing mice cells to create meat. Theres just a lot more technical challenges that they have to figure out how to ramp up and replicate that kind of meat production, said Rich Kelleman, CEO of Bond Pet Foods.

Bond is using the same approach to genetic engineering used to synthetically produce rennet for cheese production or insulin for diabetics.

What were doing is isolating a skeletal muscle protein so the building blocks of meat and inserting the DNA from that into a microbe, and then using the machinery of the microbe to produce identical animal proteins that you get on a farm and field, drying it down and then using that in a broader recipe to provide high quality nutrition, Kelleman said.

The major pet food companies are also looking for environmentally friendly, alternative proteins that could be inexpensive to scale up as a replacement for conventionally raised meat.

One area were currently exploring is looking at insects as a potential protein source, said Richard Butterwick at the Waltham Institute. They are potentially much more sustainable than traditional mammalian sources of protein and potentially very nutritious, as well.

Venture capital funds are eyeing the potential of cultured alternatives

Last year, Bond completed a $1.2 million seed round of funding and won a $10,000 innovation award from Purina.

Because Animals won this years innovation award and Wild Earth received a $200,000 investment from Mars Petcare during its 2018 investment round. So far, Wild Earth has raised over $16 million from various venture capital funds to pay for its continued growth.

These are relatively small amounts on the scale of the industry, but there is a sense of momentum.

All the big pet food manufacturers are looking at their supply chain and they see challenges with the growth of the pet food market and the population overall, more people means more pets, Kelleman said. Theyre looking for ways that they could mitigate the risk.

Richard Butterwick said that the main concern is that a pets nutritional needs are understood by their owners. He said consumer trends and the humanization of pets should not compromise pet needs, just because there is a trend towards more sustainable eating for humans.

A 2015 study in the Journal of Animal Science looked at the changing attitudes of pet owners choice in food for their companions. The study said it was paramount that sustainability be weighed against animals nutritional demands.

That means conscientious pet owners need to be wary of compromising a pets health just because eating kogi fungus, cricket treats, or lab-grown meats is trending for humans.

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University of Birmingham Vice-Chancellor Professor Sir David Eastwood with representatives of partner organisations at the signing ceremony in Delhi.

Experts at the University of Birmingham will work with partners in India across education, healthcare, genetic engineering and sports science.

Vice-Chancellor Professor Sir David Eastwood signed a range of Memoranda of Understanding (MoU) with the Universitys partners at a special signing ceremony in Delhi.

The agreements form a key part of the Universitys strategic vision to continue building meaningful education and research partnerships in India.

Professor Sir David Eastwood signed MoUs with:

The University of Birminghams collaborative research output with India partners has almost doubled over the last five years. We currently have over 40 joint research projects of outstanding quality, commented Professor Sir David Eastwood.

We are a global university with a civic heart and a long, illustrious relationship with India. Signing these exciting new agreements with partners in areas such as health, transport and environment gives us a great opportunity to further contribute to Indian society as we continue to forge meaningful research and education partnerships in India.

The University and ICGEB plan to work together on multidisciplinary research including immunity and infection, as well as projects tackling human diseases, compound screening for identifying autophagy modulators, and exchanges of students and staffs across relevant projects.

Working in partnership with CIPLA, University experts will develop healthcare Continuous Professional Development (CPD) programmes.

Researchers at PDPU and Birmingham will continue working on the joint India-H2O project, which is developing, designing and demonstrating high-recovery, low-cost water treatment systems for saline groundwater, as well as domestic and industrial wastewaters. The partners will also identify new research opportunities.

The agreement with Technofin will see the partners working together on a bid to provide rail research and consultancy to the Dedicated Freight Corridor Corporation of India Ltd., to support the establishment of a Heavy Haul Research Institute. They will also develop other infrastructure-related research.

Manipal engineering students will be able to join Birmingham courses in Civil Engineering, Computer Science and Engineering, Electrical and Electronics Engineering, Mechanical Engineering and Mechatronics Engineering - after completing two years of study in India, graduating with degrees from both universities.

University experts will work with Inspire Institute of Sport to develop bespoke distance-learning and blended CPD programmes for the development of the Institutes staff, as well as developing scholarships for postgraduate study in sports science. The MoU is an outcome of the India-UK Sports Alliance set up by the UK Governments Department for International Trade to drive collaboration in sports between the two countries.

Crispin Simon, Her Majestys Trade Commissioner for South Asia, UKs Department of International Trade and British Deputy High Commissioner, Mumbai and West of India, said: I am delighted that the University of Birmingham is strengthening its presence in India across education, healthcare, genetic engineering and sports science. The UK government has played an instrumental role in establishing their partnership with Inspire Institute of Sport, and we will continue to support their work in India.

I am also glad that Professor Tim Cable from the University of Birmingham has made significant contributions to the Indian-UK Sports Alliance organised by the UK government, to bring together influential individuals in both countries to help drive collaboration. I look forward to his continued participation.

Read more from the original source:
University of Birmingham signs up for strategic research vision in India - University of Birmingham