Category Archives: BioEngineering

On Valentines Day, BioSpace would be remiss not to mention, er, matters of the heart. There are reportedly 59 life sciences companies or organizations worldwide that focus on the cardiovascular system, ranging from the Aab Cardiovascular Research Institute based in West Henrietta, New York to XyloCor Therapeutics, headquartered in Philadelphia, Pennsylvania. That number is probably low.

But no matter how you look at it, there is a significant amount of work being done on cardiovascular diseases. Heres a look at just some of the recent news.

On January 28, 2020, the U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Companys Trijardy XR for lowering blood sugar in adults with type 2 diabetes.

Trijardy XR is a triple-combination pill that includes Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended release. It is prescribed along with diet and exercise for decreasing blood glucose levels in type 2 diabetes.

In the U.S., Jardiance and Radjenta are once-daily tablet used to treat adults with type 2 diabetes. Jardiance has also been approved to decrease the risk of cardiovascular death in adults with type 2 diabetes with known cardiovascular disease.

On February 3, 2020, researchers with the University of South Florida (USF Health) identified key mechanisms behind the loss of capillaries, which drives numerous diseases, including high blood pressure, diabetes, malignant cancer and a variety of cardiovascular and neurodegenerative diseases.

Capillary regression (loss) is an underappreciated, yet profound, feature of many diseases, especially those affecting organs requiring a lot of oxygen to work properly, said George Davis, professor of molecular pharmacology and physiology at the USF Morsani College of Medicine in Tampa, Florida. If we know how blood vessels are altered or begin to break down, we should be able to fix it pharmacologically.

Davis led a research project that identified the three major proinflammatory mediators that drive capillary loss. They published the research in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The mediators are interleukin-1 beta (IL-1), tumor necrosis factor alpha (TNFalpha) and thrombin). They found that individually and even more so when combined, these directly drive capillary regression. They also identified drug combinations that can neutralize antibodies that specifically block IL-1 and TNFalpha, that can interfere with this capillary loss.

On January 27, 2020, AstraZeneca announced that its Brilinta (ticagrelor) hit the primary endpoint in the Phase III THALES trial in stroke. The study showed that 90mg of Brilinta twice a day and taken with aspirin for 30 days, provided a statistically significant and clinically meaningful decrease in the risk of stroke and death compared to aspirin alone. The trial was run in more than 11,000 patients who had a minor acute ischemic stroke or high-risk transient ischemic attack (TIA) in 24 hours before the beginning of treatment.

Results of the Phase III THALES trial showed Brilinta, in combination with aspirin, improved outcomes in patients who had experienced a minor acute ischemic stroke or high-risk transient ischemic attack, said Mene Pangalos, executive vice president, BioPharmaceuticals R&D. We look forward to sharing the detailed result with health authorities.

Earlier that month, however, the company announced that after a recommendation from an independent Data Monitoring Committee, it was abandoning its Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) for mixed dyslipidemia (MDL). Epanova is a fish oil-derived combination of free fatty acids composed mostly of EPA and DHA. It was approved in the U.S. as an adjunct to diet to decrease triglyceride levels in adults with severe high triglycerides. That indication wasnt changed by the data from the STRENGTH trial.

AstraZenecas exit from the fish oil drug trial largely leaves Amarin Corporations Vascepa (icosapent ethyl) as the only fish-oil drug to not only treat high triglycerides, but to decrease the risk of first and subsequent heart attacks, strokes and heart problems. In its clinical trials, Vascepa decrease those risks by 30%.

Although derived from fish, Vascepa is not fish oil. It is made up of the omega-3 acid (EPA) in ethyl-ester form. It was designated a new chemical entity by the FDA,

The same day AstraZeneca made their announcement, another company in the market space, Acasti Pharma, also reported a failure. Its own fish oil-based candidate, CaPre (omega-3 phospholipid) for severe hypertriglyceridemia, announced topline data from its Phase III TRILOGY 1 trial. Although it reported a 30.5% median reduction in triglyceride levels compared to 27.5% in the placebo group at 12 weeks, as well as a 42.2% decrease in patients on background statins compared to 31.5%, because of an unexpectedly large placebo response, the trial did not reach statistical significance.

And as long as were belaboring the Matters of the Heart theme, in mid-December 2019, Vancouver, British Columbia-based Novoheart signed an exclusive licensing deal with Harvard Universitys Office of Technology Development.

The deal allows Novoheart to merge its MyHeart Platform with Harvards tissue-engineered scale model of the heart ventricle and bioreactor technology. Novoheart invented and commercialized the first and only human heart-in-a-jar model for drug discovery and development.

Harvards valved bioreactor technology was engineered in Kevin Kit Parkers laboratory. He is the Tarr Family Professor of Bioengineering and Applied Physics at Harvard A. Paulson School of Engineering and Applied Sciences.

The two institutions expect that the merged technology will result in a next-generation human heart-in-a-jar that will be a superior human heart model for disease modeling, drug discovery and development with unmatched biofidelity as well as significantly enhanced predictive accuracy, capacity and versatility.

In addition to developing various bioengineered human heart constructs, Novoheart wants to develop the technology into transplantable grafts for cell-based regenerative heart therapies. The companys various products include Human Ventricular Cardiomyocytes (hvCM), Cardiac Anisotropic Sheet (hvCAS), Cardiac Tissue Strip (hvCTS), and Cardiac Organoid Chamber (hvCOC). It also offers consultation and screening and phenotyping services using its 2D or 3D tissue assays.

On November 26, Novoheart announced a collaboration with AstraZeneca to develop the worlds first human-specific in vitro, functional model of heart failure with preserved ejection fraction (HFpEF). Working with AstraZenecas Cardiovascular, Renal and Metabolism team, they will initially establish a new in vitro model using Novohearts proprietary 3D human ventricular cardiac organoid chamber (hvCOC), also known as the human heart-in-a-jar.

Overall, we dont recommend buying your sweetheart a heart in a jar. Go with the classicschocolates or flowers, instead.

BioSpace source:

https://www.biospace.com/article/valentine-s-day-matters-of-the-heart-biopharma-style

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Valentine's Day Matters of the Heart, Biopharma-Style - PharmaLive

Noah Hill was turning in his physics homework as a first-year student in fall 2016 when he spied a poster advertising a three-day event for Tufts engineering startups.

I had just come to college, and entrepreneurship was all new to me, he said. He went to the event, and wound up in a group with two older students, Daniel Weinstein, E18, and Saam Borzog, D19. They were exploring a small device that would fit inside a persons mouth and track the nutritional content of what they were eating.

Over the next seventy-two hours, the three bonded over the idea so well that when the event was over, they decided to keep working on the project. I had no idea what I was getting myself into, said Hill, E21, a computer science major.

From that chance meeting grew their company UChu Biosensors, a dental technology startup that they hope will revolutionize the way dentists use real-time data to fight tooth decay. The company has shown so much promise that Hill took this year off from Tufts to travel to Shenzhen, China to work on the product at the HAX Accelerator, which provides venture capital and services to develop hardware.

My philosophy is that college will always be there, but I dont know if I can be director of software engineering of my own company, he said. Worst case scenario, this falls through and I finish my degree; best case, I keep working and can pay for my own tuition.

Hill grew up in Tacoma, Washington, where his dad worked for a nearby citys public works department. Hill tinkered with him in the garage during the weekends. He would buy old, broken cars on purpose so he could fix them, said Hill, who developed a love for math and engineering.

It wasnt until he came to Tufts that he discovered computer programming, first taking a class on it at the Experimental College. When Hill first learned how to program a Raspberry Pi, a palm-sized minicomputer, and made it print on a terminal, it blew my mind, he said. Ever since then, Ive wanted to program things.

The three-member team ran with the idea of the diet tracker for more than year before realizing that tracking so many nutrients was too complicated. Borzog, then a student at the Tufts dental school, had an aha moment, remembering how much his professors preached the importance of acidity in tooth decay.

Acid is to dental health what blood pressure it to heart disease, said Borzog. Outside of a twice-yearly checkup, however, dentists have no way to understand what is going on in peoples mouths. We usually recommend the same thing for each patientbrush and floss twice a day.

The issue is particularly important for millions of people who are more prone to dental decay, such as those on antidepressants or living with diabetes and cancer, for example. The company shifted its vision toward a device that would attach to a patients tooth and continually monitor acid levels, sending an alert to a smartphone if it rose to a critical level.

That would allow a dentist to prescribe a specific toothpaste or mouthwash to bring down acidity. Ninety-two percent of people will experience tooth decay at some point, and its completely preventable, Hill said.

Over the past two years, the team worked to create a prototype, with Weinstein overseeing the bioengineering, Borzog the dental science, and Hill the computer programming. Hills computer science courses at Tufts became real-time tutorials to create the company software.

Comp 40 skyrocketed my ability to write code, said Hill, who at one point was dealing with a software bug for two weeks. In class, they taught us how to debug assembly code, and within fifteen minutes, Id fixed it.

At the same time, the trio was buoyed by the Tufts Entrepreneurship Center, winning its $15,000 Montle Prize and $5,000 Ricci Prize in 2017. That in turn garnered the interest of thencenter director Jack Derby and other faculty members, who helped the trio hone their message and connected them with potential funders.

The science is there, but the guys also have very positive and friendly attitudes, said Derby, now a lecturer at the Tufts Gordon Institute. That makes all of us in the center want to do more for them.

Working at Tufts Launchpad | BioLabs, the team created a proof of concepta complete working sensor on a mouthguard, and with Derbys help, began traveling around the country and overseas making a pitch for funding.

The teams drive and persistence are unique among Tufts students, says computer science associate teaching professor Ming Chow, E02, EG04, who taught Hill in Web Programming in spring 2018. Tufts talks about entrepreneurship, Chow said, and now Noah has gone on to do it.

With an initial goal of raising $500,000, the company was only able to bring in $291,500 before the opportunity with HAX came along. The accelerator provides companies with $250,000 in venture capital, as well as engineering and marketing teams, to complete their product. The only catch is that they have to move to China to do it.

Hill didnt hesitate, leaving Tufts this fall to travel with Weinstein to Shenzhen, where the two have worked twelve-to-sixteen hour days to design the hardware, firmware, server architecture, and web interface.

When they are done with the product design, they will then head to Silicon Valley in the spring in hopes of raising $2 to $3 million in seed capital to see the device through the regulatory process. If all goes well, they hope to sell to their first patients in 2021 or 2022.

The experience has brought out my inner strength and helped me realize what Im passionate about, said Hill, reflecting on how far hes come since that startup event his first year at Tufts. Whatever you want to do is really possible if you work hard and meet people and leverage the resources that are available.

Michael Blanding is a Boston-based freelance writer.

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Taking the Leap into the Startup Worldas a Student - Tufts Now

In the inevitable shift away from fossil fuels, Genomatica announced the first commercial production ... [+] of bio-based nylon. Companies that seize the economic and environmental advantages of biomanufacturing stand to lead the way, whether its fabrics or face creams.

In the inevitable shift away from fossil fuels, Genomatica announced the first commercial production of bio-based nylon. Companies that seize the economic and environmental benefits of biomanufacturing stand to lead the way, whether its fabrics or face creams.

When we think of biotechnology, its easy to think just about pharmaceuticals. Even the broader term bioeconomy may only bring to mind things like agriculture, forestry, and food.

But the bioeconomy is best thought of as turning biomass into business, plants into products. What we call the bioeconomy today made up most of our economy before the 20th century, when petrochemistry and synthetic chemistry gave rise to a revolutionary material that became ubiquitous worldwide: plastics.

In the 21st century, consumers are increasingly demanding products that reflect their more sustainable values and lifestyles. Chemistry is giving way to synthetic biology, and engineered organismsusing the same kind of fermentation we use to make wine, bread, or kombuchacan now make the chemical building blocks for shoes, cars, and carpets.

There is just one question: Which producers will have the foresight to lead this biomanufacturing revolution?

Recently, a bioengineering company called Genomatica reached a milestone that epitomizes this shift from fossil fuels to biology. Genomaticaannouncedit had made a ton of the chemical building block that industry relies on to make nylon-6using a renewable fermentation approach.Heres why that matters.

First, its an economic opportunity. The nylon industry is worth $10 billion globally. Thats a huge potential market to tap into. Nylon became famous in the 1940s as a textile fiber in stockings. Today, it is found in everything from clothes to packaging.

Second, its an environmental necessity. As with most plastic production today, nylon-6 usually starts with crude oil. In this case, the molecule caprolactam is refined from crude oil and made into nylon. Every year, the world makes five million tons of nylon-6, which results in an estimated 60 million tons of greenhouse gas emissions. Producing nylon creates nitrous oxide, a greenhouse gas that is 300 times more potent than carbon dioxide. Manufacturing nylon also requires large amounts of water and energy, further contributing to environmental degradation and global warming.

Using a synthetic biology approach, Genomatica engineered microorganisms to ferment plant sugars to produce caprolactam, and therefore nylon, in a 100% renewable way. Christopher Schilling, CEO of Genomatica, thinks this is good for business and our planet.

Theres this idea that in order to be sustainable, youve got to find some totally novel material, said Schilling. But by producing the very same chemical precursor that industry would normally get from fossil fuels, he believes Genomatica can have a much bigger, more rapid impact on sustainability. As this product continues to scale, and the economics become more obvious, companies will begin to ask themselves: why would we source it any other way?

Genomatica wants to deliver sustainable nylon to brands like H&M, Vaude, and Carvico via its partnership with Aquafil, one of the largest producers of nylon in the world. Aquafils ECONYL brand of nylon takes old fishing nets, textile scraps, and other forms of nylon waste and transforms them into new yarn thats as good as virgin raw material. Aquafil sees this regeneration process as a new opportunity for the fashion and furniture industries, and a way to protect the environment.

It was important to us to establish a real connection point with consumer brands, said Schilling. As a technology innovator, Genomatica felt that the success of the product depended on being accepted at all points in the value chain. Aquafil was the best partner for that, where we could share a great story that consumer brands could latch on to and ultimately champion.

Schilling says that the initial one-ton production of the chemical precursor is a small but important step, and its next goal is to reach commercial-scale levels of 30,000-100,000 tons per year.

One of the things thats really differentiated Genomatica is our ability to scale, to know how to take something all the way from ideation to commercial realization, says Schilling.

Nylon is Genomaticas third big synthetic biology product to come to market, and its previous experience in this space is sure to help accelerate the transition from the lab bench to the marketplace.

Since 2016, Italian bioplastics company Novamont has been producing the bio-BDO at a rate of 30,000 ... [+] tons per year.

Genomaticas first big success was with 1,4-butanediol, known more colloquially as BDO. This chemical is used to make plastics, elastic fibers, and polyurethanes, and its found in everything from plastic bags to spandex. The world produces about 2.5 million metric tons of BDO every year, and at about US$2,000 per ton, the market is in the billions.

In 2012, Genomatica delivered a chemical engineering breakthrough by producing bio-based BDO with a cost-competitive fermentation process at a commercial scale. Bio-BDO is 100% bio-based and biodegradable, and can be found in athletic apparel, running shoes, electronics, and automotive applications.

A second big success came with a chemical named 1,3-butylene glycol. Few realize it, but many of our everyday personal care and beauty products are derived from crude oil. In early 2019, Genomatica announced the first commercial production of Brontideits brand name of the chemicalmade with natural plant-based sugars. As more and more of us strive to choose products that are in line with our personal values, those made with Brontide rather than fossil fuel derivatives offer consumers a choice that is kinder to the environment.

Taken together, there are now bio-based alternatives for the chemicals used to make everything from fuels to electronics, from shoes to cosmetics. Its a reminder of just how dependent we are on petrochemicals in our everyday lives.

On the performance side, our first goal is to make sure that the material delivers exactly the same performance features as you would get from conventionally or petroleum sourced nylon. Thats the same thing we did in BDO and butylene glycol, explains Schilling. He adds, When you have these large existing markets, you have to make sure you hit the spec to deliver the same quality.

Bio-based alternatives can offer another advantage over their fossil-based cousins: in some cases, they perform better. With butylene glycol, for example, heavy metals are a catalyst used in processing the ingredient from crude oil. In the final product, trace amounts of heavy metals remain. But with biomanufacturing, no catalysts are needed and theres no chemical processing, says Schilling. There are also different purity levels that were able to hit very effectively, he says.

The argument for sustainable, bio-based approaches to material precursors is a strong one. Through relatively simple fermentation processes, biology has shown time and again that it can make whatever we can pump out of the ground, offering precision, renewable production of key compounds. Bio-based caprolactam is another proof point.

The sticking point, as ever, is industry adoption. Industry leaders across the value chain need to seek out and support the scaling of sustainable and renewable bio-based components to speed their integration into a diverse array of end-products. Consumers want them, manufacturers can use them, and most importantly, the planet needs them.

Follow me on twitter at @johncumbers and @synbiobeta. Subscribe to my weekly newsletters in synthetic biology and space settlement.

Thank you to David Kirk and Kevin Costa for additional research and reporting in this article. Im the founder of SynBioBeta, and some of the companies that I write about are sponsors of the SynBioBeta conference and weekly digest heres the full list of SynBioBeta sponsors.

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Bio-Nylon Is The New Green: How One Company Is Fermenting A $10 Billion Market - Forbes

Baxter(NYSE:BAX) says its income for the past four years may have been overstated by $276 million.

The Deerfield, Ill.based healthcare products company said the figures came out of a previously announced internal probe into its foreign exchange trading practices. That investigation is now substantially complete, the company said in an SEC filing yesterday.

Baxter said its income was over-reported by $40 million for 2016, $117 million for 2017, $77 million for 2018 and $42 million for the first half of 2019. The company said it expects to file restated financial statements, its third- and fourth-quarter 2019 financial reports and its annual report by March 31, 2020.

The problem involved transactions using a foreign exchange rate convention historically applied by the company that was not in accordance with U.S. generally accepted accounting principles (GAAP). The company believes that the use of its previous exchange rate convention to generate non-operating foreign exchange gains and avoid losses had occurred for at least 10 years, Baxter said in yesterdays filing.

Yesterdays SEC filing is an important step forward in our internal investigation, the company said in a statement emailed to MassDevice.

Its important to note that these misstatements of foreign exchange gains and losses are non-operational in nature. This means they are unrelated to our core operations and business results. In fact, our preliminary 2019 results (announced January 11) reflect the fundamental strength of the business globally.

By the end of March, Baxter plans to announce our complete Q3 and Q4 2019 results and submit our restated financial results to the SEC. We take this matter very seriously and are focused on delivering these next milestones by the end of the quarter.

The Street appears to have already priced in Baxters income misstatements. BAX shares are only down slightly today.

This article has been updated with comments from Baxter.

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Baxter probe finds $276 million in overstated income - Mass Device

Blue-green algae are getting their day in the sun not that they need much of it. A new analysis of their molecular makeup could lead to better solar technology and crops that grow just fine with less sunlight.

In a new study in the journal Science Advances, researchers from Yale, Arizona State University, and Penn State University report on structural properties that allow certain blue-green algae to thrive under lower-sunlight conditions. Its the first time that scientists have been able to see these structural properties, offering clues for bioengineering hardier crops and designing more effective solar cells.

Blue-green algae, also called cyanobacteria, are microscopic organisms that grow in both water and terrestrial environments. They contribute as much as half of the photosynthesis taking place on Earth, thanks to their ability to thrive in a wide range of environments. Photosynthesis is the process by which plants and algae generate the atmospheric oxygen that sustains life on the planet.

Certain organisms can live off of light, while also being in the shade. Understanding how that works is remarkable, said Christopher Gisriel, a postdoctoral associate in chemistry at Yale and first author of the study.

Donald Bryant of Pennsylvania State University is the studys senior author.

To find out why cyanobacteria are so successful, the researchers studied Fischerella thermalis, a terrestrial cyanobacteria.

When Fischerella thermalis is deprived of bright, high-energy sunlight (called white light), it switches gears. It instead starts absorbing low-energy sunlight, known as far-red light.

How does it make this switch? Gisriel said its all about the chlorophyll the green pigment responsible for harvesting light within plants. The typical form of chlorophyll, called chlorophyll a, absorbs white light; an alternate form, called chlorophyll f, is able to absorb far-red light.

These organisms that can absorb far-red light, can actually switch back and forth, Gisriel said. If you put them in white light, they only use chlorophyll a, and theyre just like all the other cyanobacteria. But if you move them to the shade, where they have more of this lower-energy, far-red light, they actually switch out some of the chlorophyll as for chlorophyll f, and that allows them to absorb far-red light. Thats a testament to the plasticity of photosynthesis it can adapt to many environments, which I think is a pretty incredible mechanism.

Gisriel said as much as 25% of all cyanobacteria may use far-red light for photosynthesis. It allows them to grow under a forest canopy and beneath other plants on the surface of a pond, he added.

The researchers used a powerful new microscopy technique known as Cryo-EM (cryogenic electron microscopy) to cool samples of Fischerella thermalis and embed them in ice. Cryo-EM gathers thousands of images of sample particles in various orientations and uses computer algorithms to re-assemble the images into a detailed, three-dimensional composite, called a density map.

This method revealed some locations of chlorophyll f molecules present in Fischerella thermalis that are responsible for far-red light adaptation, Gisriel said.

As for future applications, the researchers said the work suggests several possibilities. Perhaps two crops could be grown together, such as tall corn with short alfalfa. Another outcome could be crops that thrive in a wider variety of weather conditions. There also may be applications for new generations of light-harvesting technology, such as photovoltaics.

This is fundamental research that paves the way, potentially, for other things, Gisriel said.

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A science discovery made in the shade - Yale News

We all want the best for our children especially when it comes to establishing a nutritious diet. My husband and I always strive to make informed decisions when it comes to our daughters health, but theres one thing we cant ever seem to agree on: organic or non-organic?

While my husband believes that organic fruits and veggies are healthier (and thus only wants to feed our daughter organic produce), I am content with giving her conventional fruits and vegetables as long as theyre washed and scrubbed thoroughly under running water. In my opinion, non-organic produce is healthy and a much more affordable option.

To avoid making a scene at the grocery store next time, I need to know: is organic better?

First things first what does organic really mean?

Organic refers to the way farmers grow, handle, and process food. To be classified as organic, foods must meet national standards set by the U.S. Department of Agriculture (USDA). As part of these standards, organic crops must be produced without conventional pesticides, synthetic fertilizers, sewage sludge, bioengineering, or ionizing radiation.

The process for producing organic fruits and vegetables includes using natural fertilizers such as manure or compost, controlling weeds naturally through methods such as crop rotation, hand weeding, mulching, and tilling, and controlling pests using natural methods and naturally-derived pesticides.

Organic food advocates believe that these farming practices produce better fruits and veggies. Here are some of the benefits of going organic:

Here is my concern (and that of many other consumers) with going organic: its expensive. Organic foods typically cost more than their non-organic counterparts. The USDA found that organic fruits and vegetables can cost more than 20 percent higher than conventional produce. Higher prices are due, in part, to more expensive farming practices.

While organic produce may cost more, thats not stopping some shoppers. Sales of organic food are steadily increasing. But some experts arent convinced that going organic is worth the cost. Heres why:

So, whats the solution? Should we buy organic produce or not?

If youre sold on the idea of going organic (like my husband) but arent ready to go completely organic (like me), you can always pick and choose. Each year, the Environmental Working Group (EWG) puts out a list, known as the Dirty Dozen, of conventionally grown foods most likely to contain pesticide residue. To help reduce your exposure to pesticides, consider buying organic versions of these produce items: apples, celery, cherries, grapes, kale, nectarines, peaches, pears, potatoes, spinach, strawberries, and tomatoes.

The EWG also produces the Clean Fifteen, a list of non-organic fruits and vegetables that are low in pesticide residues. The 2019 list includes: asparagus, avocados, broccoli, cantaloupes, cabbage, cauliflower, eggplant, frozen sweet peas, honeydew melons, kiwis, mushrooms, onions, papayas, pineapples, and sweet corn.

Balancing the health of our family is a top priority. While I may not be 100 percent sold on the idea of going organic like my husband is, I think we can find a compromise by purchasing a mix of organic and non-organic produce.

This article was originally published on IBX Insights.

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Organic vs. non-organic: The pros and cons - PhillyVoice.com