Monthly Archives: December 2020

Explained: What FDA nod for genetically modified pigs means – The Indian Express

Posted: December 18, 2020 at 7:54 pm

By: Explained Desk | New Delhi | December 18, 2020 8:45:13 pmThis undated photo provided by Revivicor, Inc., a unit of United Therapeutics, shows a genetically modified pig. (Revivicor, Inc. via AP)

This week, the US Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs referred to as GalSafe pigs. These pigs may be used for food and human therapeutics, the FDA has said. This will be the first time that the regulator has approved an animal biotechnology product for both food and biomedical purposes.

What is intentional genomic alteration?

Intentional genomic alteration in animals means making specific changes to the genome of the organism using modern molecular technologies that are popularly referred to as genome editing or genetic engineering. However, there are other technologies that can be used to make IGAs in animals.

Such changes in the DNA sequence of an animal may be carried out for research purposes, to produce healthier meat for human consumption and to study disease resistance in animals among other reasons. One example is of using IGAs to make an animal more susceptible to certain diseases such as cancer, which helps researchers get a better understanding of the disease and develop new therapies to treat it.

The FDA maintains that the only difference between an animal with an IGA and one that does not have an IGA is that the IGA gives them a new trait or characteristic, such as faster growth or resistance to certain diseases. Follow Express Explained on Telegram

Essentially, an IGA is inserted into an animal to change or alter its structure and function and the FDA makes sure that the IGA contained in the animal is safe for the animal and safe for anyone who consumes a product or food derived from the animal.

What does FDAs recent approval mean?

The FDA made the announcement this week and allowed IGA in GalSafe pigs to eliminate a type of sugar found in mammals called alpha-gal. This sugar is present on the surface of these pigs cells and when they are used for products such as medicines or food (the sugar is found in red meats such as beef, pork and lamb), the sugar makes some people with Alpha-gal Syndrome (AGS) more susceptible to developing mild to severe allergic reactions.

Since GalSafe pigs may potentially be used to produce human medical products, IGA will help eventually free these products from detectable alpha-gal sugar, thereby protecting their human consumers from potential allergies.

According to the FDA, GalSafe pigs may be used to make the blood-thinning drug heparin.

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Spatial Genomics & Transcriptomics Market Demand is Expanding at a Stellar Pace in the Years to Follow – BioSpace

Posted: December 18, 2020 at 7:54 pm

The demand within the global spatial genomics and transcriptomics market is expanding at a stellar pace in the years to follow. Advancements in molecular biology have paved the way for revenue inflow into the global spatial genomics and transcriptomics market. The need for studying genetic patterns in humans, animals, and plants has generated new opportunities for market expansion, Genetic engineering has emerged as a robust domain within nascent biological sciences, creating room for experimentation and analysis. The applications of genomics in molecular biology and genetic studies has given a thrust to market expansion.

In this custom review, TMR Research delves into the extrinsic and intrinsic trends that are shaping the growth graph of the global spatial genomics and transcriptomics market. The domain of biological sciences has encapsulated new technologies for studying sizes, compositions, and archetypes of human genes. This is playing a vital role in driving sales across the global spatial genomics and transcriptomics market. This review also assesses the impact of advancements in genetic engineering to decode market growth.

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Spatial Genomics & Transcriptomics Market: Notable Developments

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Spatial Genomics & Transcriptomics Market: Growth Drivers

The high incidence of genetic disorders has probed the medical industry to invest in new technologies for genetic engineering and gene transfer studies. Several medical centers and research units are investing in the study of dyslexia, downs syndrome, and other genetic inconsistencies. This has created fresh avenues for growth across the global spatial genomics and transcriptomics market. In addition to this, the use of next-generation genetic studies for understanding genetic disorders has also given a thrust to market expansion.

The importance of microbiology in genetic studies has created a boatload of opportunities for growth and expansion across the global spatial genomics and transcriptomics market. The use of spatial genomics to understand the structure and composition of genes has enabled the inflow of fresh revenues into the global market. Besides, the use of genetic studies in the domain of veterinary care has also generated humongous opportunities for market expansion. The study of human and animal genes often goes hand-in-hand for the purpose of core research and analysis.

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From the archives – MIT Technology Review

Posted: December 18, 2020 at 7:54 pm

These concerns have proven to be well founded. Many species of insects no longer respond to the effects of pesticides. World pesticide use has increased dramatically, but the percentage of crops lost to pests has not declined. Insects consume as much as one-third of the Asian rice crop annually, and in the United States losses of fruit and vegetable crops from plant diseases may exceed 20 percent. Clearly, just pouring on more chemicals is no answer.

From Food Irradiation: Will It Keep the Doctor Away? November/December 1997:

Nearly 200 people in the US, most of them children or elderly, die each week from illnesses they contract from food. This spring, President Clinton called for new steps using cutting-edge technology to keep our food safe. One of the technologies that Clinton singles out is food irradiation.

It will probably take some truly traumatic E. coli outbreak before the food industry gets serious about irradiation, says James Tillotson, director of the Food Policy Institute at Tufts University. Without such a crisis, consumers wouldnt think of demanding irradiated food and companies that explore irradiation [would be] open to attacks by activist groups. No one is willing to get that kind of attention, he says, even when they might be doing the best thing for consumers.

From Why We Will Need Genetically Modified Foods, January/February 2014:

Plant scientists are careful to note that no magical gene can be inserted into a crop to make it drought tolerant or to increase its yieldeven resistance to a disease typically requires multiple genetic changes. But many of them say genetic engineering is a versatile and essential technique. Its an overwhelmingly logical thing to do, says Jonathan Jones, a scientist at the Sainsbury Laboratory in the U.K. The upcoming pressures on agricultural production, he says, will affect millions of people in poor countries. At the current level of agricultural production, theres enough food to feed the world, says Eduardo Blumwald, a plant scientist at the University of California, Davis. But when the population reaches nine billion? he says. No way, Jos.

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From the archives - MIT Technology Review

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22nd Century Group Achieves Breakthrough Hemp/Cannabis GMO Technology; Granted New Patent for Controlling Genes Responsible for Production of CBD,…

Posted: December 18, 2020 at 7:54 pm

WILLIAMSVILLE, N.Y., Dec. 17, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that it was granted a new U.S. patent related to the control of cannabinoid and terpene production in plants. This new intellectual property exclusively provides 22nd Century with unique and powerful tools to alter the cannabinoid biosynthesis pathway in hemp/cannabis plants.

"We are delighted to receive this patent, which is the result of work carried out by our own scientists. This important, new technology will allow us to genetically modify hemp/cannabis plants to modulate their cannabinoid and terpene profiles in order to tailor these plants therapeutic qualities and enhance the consumers hemp/cannabis experience," said Juan Sanchez Tamburrino, Ph.D., vice president of research & development at 22nd Century Group. "Our patent application describes eight promoters, which are essentially molecular on/off switches, covering all of the major steps in the cannabinoid biosynthesis pathway. Typically, developing hemp/cannabis plants with new cannabinoid or terpene profiles could take 10 to 20 years using traditional breeding methods. Now, with the combined technologies and know-how of 22nd Century and KeyGene, we expect to shorten the development timeline to create new, differentiated, hemp/cannabis plant lines in just 4 to 5 years. Doing so will provide the Company and its potential licensees and customers with significant competitive advantage as hemp/cannabis continues to penetrate the life science, consumer product, and pharmaceutical markets.

At 22nd Century Group, we take a scientific and solutions-oriented approach to advancing ground-breaking, plant-based technology. We are excited to secure this patent, and we believe that it demonstrates our unique and leading role in plant science innovation within the $100 billion global hemp/cannabis market, said James A. Mish, chief executive officer of 22nd Century Group.

The new patent, published as U.S. Patent No. 10,787,674 B2 and entitled "Trichome specific promoters for the manipulation of cannabinoids and other compounds in glandular trichomes," enables 22nd Century to develop and deliver new hemp/cannabis plants that are designed to produce cannabinoids more efficiently. The Company can potentially increase the yield of plants, stabilize the level of cannabinoids that are produced, and create custom cannabinoid profiles optimized for specific therapeutic uses. 22nd Century will also be able to potentially modulate the terpene levels within the plant increasing them to deliver new strains of cannabis for the adult-use/recreational market and reducing them to remove the odor and taste for improved application in foods and beverages.

Cannabinoids, such as CBD, CBC, and CBG, are valuable compounds that hold great promise for the development of new medicines and other therapeutic applications. Cannabis sativa is the only plant species that produces significant amounts of these compounds including more than one hundred different cannabinoids in varying quantities. In nature, cannabis plants restrict production of these potentially toxic compounds to the trichomes which are tiny hair-like stems and globes that grow on the surface of the plant. To successfully manipulate cannabinoids, the Companys new technology activates molecular promoters, on/off switches, specifically and only in the plants trichomes where the majority of cannabinoids are produced. These regulatory sequences dynamically enhance or restrict gene expression levels, controlling the expression of genetic information that leads to the production of cannabinoids.

About 22nd Century Group,Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Centurys primary mission in tobacco is to reduce the harm caused by smoking through the Companys proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes. The Companys primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more atxxiicentury.com, on Twitter@_xxiicenturyand onLinkedIn.

Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as anticipate, believe, consider, continue, could, estimate, expect, explore, foresee, goal, guidance, intend, likely, may, plan, potential, predict, preliminary, probable, project, promising, seek, should, will, would, and similar expressions. Actual results may differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in Risk Factors in the Companys Annual Report on Form 10-K filed on March 11, 2020 and on Quarterly Reports on Form 10-Q. All information provided in this release is as of the date hereof, and the Company assumes no obligation to publicly update or revise any forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

Investor Relations & Media Contact:Mei KuoDirector, Communications & Investor Relations22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

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Growth Opportunities in Digital, Microbiome-based, and Preventive Healthcare Technologies, 2020 Report – Focus on Latest Advancements for Chronic Pain…

Posted: December 18, 2020 at 7:54 pm

DUBLIN--(BUSINESS WIRE)--The "Growth Opportunities in Digital, Microbiome-based, and Preventive Healthcare Technologies 2020" report has been added to ResearchAndMarkets.com's offering.

This edition of the Life Science, Health & Wellness Technology Opportunity Engine (TOE) provides insights across recent innovations in digital health, microbiome, and flu vaccines technologies. The TOE also provides insights across latest advancements for chronic pain management and COVID-19 testing.

The TOE will feature disruptive technology advances in the global life sciences industry. The technologies and innovations profiled will encompass developments across genetic engineering, drug discovery and development, biomarkers, tissue engineering, synthetic biology, microbiome, disease management, as well as health and wellness among several other platforms.

The Health & Wellness cluster tracks developments in a myriad of areas including genetic engineering, regenerative medicine, drug discovery and development, nanomedicine, nutrition, cosmetic procedures, pain and disease management and therapies, drug delivery, personalized medicine, and smart healthcare.

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/r/v6l8dq

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Growth Opportunities in Digital, Microbiome-based, and Preventive Healthcare Technologies, 2020 Report - Focus on Latest Advancements for Chronic Pain...

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Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal – JD Supra

Posted: December 18, 2020 at 7:50 pm

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death. Reduction in sight is the human faculty that can have the greatest effect on quality of life in the aged -- a faculty that begins to decline in the 4th or 5th decade of life and doesn't get better (when it does) without medical intervention.

But what if there were a way to rejuvenate sight? That prospect is the tantalizing suggestion in a paper published on December 2nd entitled "Reprogramming to recover youthful epigenetic information and restore vision," Nature 588: 124-29*. The basis of the report is the recognition that many of the age-related effects on vision are an example of gene expression differences associated with epigenetic changes in chromosomal DNA. Epigenetics is a phenomenon of gene structure and expression involving small differences in nucleotide bases, typically methylation of cytosine residues at specific (CpG) sites. These changes have been studied in normal development, where gene expression changes arise as different cell types properly differentiate and act as a molecular "clock" reflecting age. The ability to turn back cellular time has been demonstrated by the development of induced pluripotent stem cells (iPSCs), wherein terminally differentiated somatic cells (typically fibroblasts) can be turned into pluripotent cells. Pluripotent cells are capable of differentiating into cells of each embryonic germinal layer (ectoderm, mesoderm, endoderm), and iPSCs can be produced by expressing four specific genes: OCT4, SOX2, KLF4 and MYC. All of these genes encode transcription factors capable of affecting (and effecting) developmentally relevant gene expression. Consequent to this "de-differentiation" occasioned by expression of these genes is a "resetting" of the epigenetic patterns associated with development. In this paper the researchers hypothesized that resetting these epigenetic patterns could also rejuvenate neuroretinal cells to reinvigorate and overcome the ocular nerve damages by glaucoma in an animal model.

Because one of these genes (MYC) is also associated with cancer development (i.e., it is an oncogene) the researchers developed an inducible expression construct that expressed only the OCT4, SOX2, and KLF4 members of the quartet (OSK). (This decision was also informed by the experience of other researchers that continuous expression of all four genes in animal models resulted in teratomas or was fatal within days of introduction.) Their system used a polycistronic (i.e., all the genes in one linear array) construct of all three genes regulated by a tetracycline response element (TRE) promoter in a adeno-associated viral vector. This construct was tested by introduction into fibroblasts from aged (20 month old) mice and gene expression related to aging (i.e., that showed differential expression with age) was evaluated. These studies showed that OSK expression for 5 days resulted in a "youthful" mRNA expression pattern in these genes (without any effect on the terminal differentiation state of the fibroblasts).

The TRE promoter enabled selection for or against expression of the OSK gene cassette; as the authors explain "[t]he TRE promoter can be activated either by reverse tetracycline-controlled transactivator (rtTA) in the presence of the tetracycline derivative doxycycline (DOX) ('Tet-On') or by tetracycline-controlled transactivator (tTA) in the absence of DOX ('Tet-Off')." Simply put, the presence of absence of DOX in the animal's drinking water determined whether the expression cassette is "on" or "off," as illustrated in this figure:

Long-term (10-18 months) expression of this cassette was achieved in both young (5 months-old) and aged mice with no tumorigenesis or other negative side effects being observed.

To test the ability of induced OSK expression to rejuvenate optical nerve cells the researchers examined retinal ganglion cells (RGC, which project axons away from the retina informing the optic nerve) in an optic nerve crush injury model (which mimics the effects of optic nerve injury due to inter alia glaucoma). The construct was delivered by injection into the vitreous humor and resulted in about 37% of the RGCs taking up and expressing the OSK genes in response to DOX administration. A separate cohort of mice were administered versions of the construct where DOX inhibited OSK expression. In these experiments, "the greatest extent of axon regeneration and RGC survival occurred when all three genes were delivered and expressed as a polycistron within the same AAV particle" according to the researchers. In contrast, inhibition of OSK expression in the "Tet-Off" mice showed no axonal growth. Moreover, delivery of the OSK genes individually in separate viral vectors or in pairs also did not show axonal growth, indicating the need for these genes to be expressed together in proper relative amounts provided by the polycistronic construct. The researchers also found OSK expression induced expression of Stat3, a gene know to encourage regeneration. These results were obtained in using 12-month-old mice as well as 1- and 3-month-old mice, which indicated, as the authors note, that "ageing does not greatly diminish the ability of OSK transcription factors to induce axon regeneration." Increased axonal growth from RGCs was found even after crush injury, an effect found with no other treatment modalities.

The researchers then determined whether these reinvigorated RGCs showed changes in DNA methylation patterns. In the absence of DOX-induced OSK expression injury in this model caused an "accelerated" aging pattern, whereas in the presence of DOX-induced OSK expression counteracted this effect according to the results reported in this paper. Interestingly, this preservation of a "youthful" pattern of DNA methylation was found to be enriched at genes "associated with light detection and synaptic transmission." Having shown this association the researchers then investigated whether axonal regeneration required youthful changes in DNA methylation. These experiments were performed by reducing expression of genes that caused DNA demethylation in RGCs (and whose expression was known to be increased in cells expressing OSK) and detecting that axonal regeneration did not occur in these mice even in the presence of DOX-induced OSK expression.

Whether these effects of OSK expression would also be seen in human neurons was investigated using differentiated human neurons in vitro. Neurons harboring an OSK-encoding construct were treated with vincristine (a drug that occasions axon injury) and DOX-induced OSK expression was shown to "counteract[] axonal loss and the advancement of DNA methylation age," showing a 15-fold greater area of proliferation in OSK-expressing cells than control vincristine-treated neural cells. These cells also showed the demethylation-dependent characteristics that were shown in RGCs in the mouse optic nerve crush injury model.

The most clinically significant result disclosed in this paper involved the effect of OSK expression in a glaucoma model in vivo. Intraocular pressure was increased to pathological levels by injecting microbeads unilaterally into the anterior chamber of mouse eye for 21 days. At 4 weeks, after these animals showed correspondingly unilateral decreases in axonal density and the number of RGCs present in the treated eye. The viral vector encoding inducible OSK expression thereafter was introduced by intravitreal injection followed by DOX-induced OSK expression for 4 weeks. Compared with control (introduction of saline or viral vectors not encoding OSK into the microbead-treated eyes) the OSK vector-treated eyes showed "restored axon density equivalent to that in the non-glaucomatous eyes, with no evidence of RGC proliferation." These mice also showed a reversal of vision loss caused by the glaucomatous injury. Together these results indicated that OSK expression could be a therapy for glaucoma in humans.

Finally, the paper reports efforts to determine whether OSK expression could improve age-related (as opposed to injury- or pathology-related) vision problems. In these experiments, 3-and 11-month-old mice were treated by intravitreal injection of DOX-inducible OSK encoding constructs and OSK expression induced for 4 weeks. Twelve-month-old mice showed age-related visual acuity and RGS electrical activity diminution which was reversed by DOX-induced OSK expression. However, these phenotypic changes were not observed to be associated with an increased number of RGCs or axon density, which prompted these researchers to hypothesize that the effect were dependent on changes in gene expression ("transcriptomic changes" as these were termed in the paper). RGCs from treated or untreated 12-month-old mice were isolated and compared with RGCs from 5-month-old mice and expression of 464 genes were found to be altered: expression of almost all (90%) of these genes were found to be restored to youthful levels in OSK-expressing RGCs. The participation of DNA methylation changes in aged RGCs in producing a youthful pattern of gene expression was further assessed and validated using artificial intelligence/machine learning approaches.

The results reported in this paper suggest therapeutic interventions that could improve vision in the aged human population even in the absence of vision-impairing pathologies such as glaucoma. Although cautious to mention that "we do not wish to imply that DNA methylation is the only epigenetic mark involved in this process" and "[i]t is likely to involve other transcription factors and epigenetic modifications," the authors are not blind to the implication that:

[W]e show that it is possible to safely reverse the age of a complex tissue and restore its biological function in vivo. Using the eye as a model system, we present evidence that the ectopic expression of OSK transcription factors safely induces in vivo epigenetic restoration of aged CNS neurons, without causing a loss of cell identity or pluripotency. Instead, OSK promotes a youthful epigenetic signature and gene-expression pattern that causes the neurons to function as though they were young again. The requirement for active demethylation in this process supports the idea that changes in DNA methylation patterns are involved in the ageing process and its functional reversal.

* By researchers from Harvard Medical School, Yale University School of Medicine, Massachusetts General Hospital, UCLA Geffen School of Medicine, and The University of New South Wales Medical School.

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Biostimulants fighting drought and heath – hortidaily.com

Posted: December 18, 2020 at 7:50 pm

Drought costs farmers around the world 10bn in crop losses every year but new trial results show that combining biostimulants with micronutrients could be the answer to food security.

The study, by researchers at Nottingham Trent University in collaboration with Micromix, looked at the effect of a hybrid biostimulant with nutrients on drought and heat tolerance in a range of crops. It found that the product changed the plants response to stress, increasing drought tolerance by 25-35% and boosting yields by up to 30%.

This is really game-changing it could offer a big contribution to global food security, says Chungui Lu, Professor of sustainable agriculture at the University. In the UK alone, we could save millions of Pounds in lost crops.

Abiotic stress - due to extreme temperatures, water, salt and solar radiation - induce a metabolic and epigenetic change in a plant, weakening its natural defense mechanisms and increasing its susceptibility to disease, pests and subsequent crop failure, explains Prof Lu. Biostimulants have the potential to affect a plants response to this stress, stimulating its own natural processes, while micronutrients enrich its growing environment. This new formulation comprises a number of key nutritional materials, including micronutrients, in a novel combination with several biostimulant components, which will suppress abiotic stress and stimulate further growth.

The trial is the latest to be carried out on this new technology, after it produced remarkable effects under initial testing on protected salad and field crops in the Middle East, South East Asia and Europe. We realised we had accidentally discovered a new kind of synergy, and needed to validate it scientifically, says Wilson Boardman, founder at Micromix and product developer. In 2014, with Prof Lu, he secured a 247,000 Innovate UK research grant, through which they discovered that the key genes relating to heat tolerance were strongly upregulated by the new technology.

This 2014 trial focused on bell peppers, which are very heat sensitive at 28C they start to wilt and at 30C they stop growing. But the treated crops were still actively growing at over 30C, boosting yields by 20% and shelf life by 44%, alongside an improvement in fruit mineral content. This has directly led to important new discoveries in epigenetics and a further research project, says Prof Lu.

In 2018 Mr Boardman and Prof Lu secured an 807,948 Innovate UK grant to further investigate the genetic influence of the product. Prof Lu looked at a variety of crops, including wheat, peas, Pak choi and potatoes, and discovered specific genes which were triggered by the biostimulants, using plant genomic / transcriptomic technologies. This reduced the negative impact of stress and stimulated plant growth.

We identified 178 key genes that are affected by the new biostimulant technology, which provides insight into gene regulation and molecular markers for breeding programmes targeted at drought tolerance, says Prof Lu. This will have a big impact for agriculture, protecting against climate change and directly protecting crop growth and quality. For example, treated crops increased cutin formation and reduced respiration, preventing water loss, while also increasing some enzymes and defense activity, boosting nutrient transfer, growth and disease resistance.

Prof Lu plans to publish his scientific paper in early 2021, and will then apply for further grant funding to help develop the next generation of biostimulants. We want to design larger field trials across more crops, to identify the correct rate and timing of application for different crops.

Micromix plans to launch products based on the research to market in the next two years, although application techniques will be refined as the research continues. The University is really excited, says Prof Lu. It will be really good to do further research into improved crop quality. The outputs of the research will enable the successful commercialisation of novel farming systems, which will in turn help to improve food security, reduce the environmental impact of food production, create local employment and contribute to community health, wellbeing and sustainability.

For more information:Micromixwww.micromix.com

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2017 Amtrak tragedy becomes call-to-action for Blood Donor Day this Sat., Dec. 18 – ilovekent.net

Posted: December 18, 2020 at 7:49 pm

The 2017 Amtrak 501 train derailment demonstrated that when it comes to emergency needs, the Pacific Northwest blood supply needs to be stocked and at the ready community ready.

Governors Kate Brown and Jay Inslee have recognized this coming Saturday, Dec. 18, 2020 as Washington and Oregon Blood Donor Day in recognition of the donors who stepped up before and after the accident.

Bloodworks Northwest is inviting the community to take part by donating a pint of blood at centers or pop-up blood drives across the region to commemorate the vital role local donors play in emergency readiness. All donors who give on Dec. 18 will each receive a special pin.

Having blood on the shelves is essential when unforeseeable emergencies or tragedies happen.

The 2017 Amtrak train tragic event demonstrated that when it comes to patient needs, theres no such thing as a holiday. Demand for blood is continuous to support local patients having surgeries, trauma care and organ transplants as well as patients needing blood for cancer treatment. It typically takes 1,000 donors to meet community need. This month, Bloodworks needs an additional 300 donors a week to keep up with hospital requests for blood. Not sure whether youre eligible to donate blood? There are some basic qualifications to donatetypically youll need to be at least 18, at least 110 pounds and in good health. But many other factors, like travel, tattoos, and vaccinations people think might disqualify them arent true.

Our mission calls on all of us our community to be prepared and ready for anything, said Bloodworks President and CEO Curt Bailey. Hospitals need donors to keep donating throughout the winter season and to make it a lifesaving habit.

Donating blood in December is also an important step in learning if you have Sars-CoV-2 (COVID- 19) antibodies. Thats because Bloodworks is testing all donations for COVID-19 antibodies to help donors learn if they have the antibodies powerful in helping critically ill coronavirus patients through convalescent plasma donation.

About December 18, 2017On December 18, 2017 the Amtrak 501 passenger train heading from Seattle to Portland tragically derailed, prompting immediate action by first responders to aid everyone aboard the train. The injured passengers would be transported to local hospitals, and cared for with 150 blood donations made by our community. The care provided was only possible because Bloodworks shelves were stocked, weeks prior, with enough blood. The accident underscores the necessity for the community to be prepared for the next local emergency.

About December 18, 2020

Additional Resources:For the latest information on COVID-19 please visit the CDC website, Washington State Department of Health COVID-19 main page, and Oregon Health Authority.

Bloodworks Donor Centers and Pop-Up Centers:Appointments and information at BloodworksNW.org or 800-398-7888. See our list of Donor Centers and Pop-Up locations.

Test results will indicate if a persons immune system has produced antibodies to the virus, regardless of whether you ever showed symptoms. Information at bloodworksnw.org.

About Bloodworks NorthwestBloodworks Northwest is backed by 75 years of Northwest history and 250,000 donors. It is local, nonprofit, independent, volunteer-supported and community-based. A recognized leader in transfusion medicine, Bloodworks serves patients at hospitals in Washington, Oregon and Alaska partnering closely with local hospitals to deliver the highest level of patient care. Comprehensive services include blood components, complex cross-matching, specialized lab services for organ transplants, care for patients with blood disorders, and collection of cord blood stem cells for cancer treatment. Bloodworks Research Institute performs leading-edge research in blood biology, transfusion medicine, blood storage and treatment of blood disorders. Patients with traumatic injuries, undergoing surgeries or organ transplantation, or receiving treatment for cancer and blood disorders all depend on our services, expertise, laboratories and research. Blood donation appointments can be scheduled at bloodworksnw.org.

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The unsexy side of Covid-19 vaccines gets Wall Streets attention – Deccan Herald

Posted: December 17, 2020 at 7:56 am

The situation was dire. As the pandemic raged in March, some Covid-19 patients in Milan were going into septic shock, and their blood pressure was perilously low.

A California drug company wanted to ship emergency medication to those patients, but commercial flights to Italy had been drastically scaled back. So it called PCI Pharma Services, a Philadelphia company that specialises in packaging and shipping drugs around the world. It took nearly a week, but PCI secured permits and arranged for courier jets, drivers and trains to deliver the drugs to Milan.

That day when the drug arrived, six people were saved, said Salim Haffar, PCIs chief executive.

As countries prepare to distribute hundreds of millions of Covid-19 vaccines some of which require storage as cold as the South Pole in winter and meticulous handling the highly specialised operations of companies like PCI Pharma are in heavy demand. And Wall Street, which likes nothing better than a hot trade with the potential for big profits, is rushing to grab a piece of the action.

Investors were already snapping up shares of vaccine-makers like Moderna and Pfizer, whose vaccine, developed with BioNTech, was introduced in the United States on Monday and requires an exceptionally low storage temperature of minus 70 Celsius (minus 94 degrees Fahrenheit). FedEx and UPS, whose shares have already risen this year as the pandemic forced millions to rely on online shopping, could benefit further from their roles in vaccine delivery.

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But in recent months, private equity firms and wealthy individual investors have also been seizing on smaller companies like PCI Pharma, whose cold-storage operations will play a crucial role in delivering Covid vaccines to the public.

Until recently, the temperature-controlled storage and shipping of pharmaceutical products, known as the cold chain, was a relatively sleepy corner of the health care industry. The technology to preserve animal-based cells and tissues by transporting them in cold conditions has been available since the 1950s, and certain breakthroughs in cancer research in the last decade increased demand for cold-chain transportation.

But the virus, and the temperature-sensitive vaccines that are poised to combat it, have brought new attention to the cold-chain delivery systems in the United States and beyond. Even Saturday Night Live featured a cooler full of vaccines during a recent episode.

The companies getting attention from Wall Street are notable for how niche their operations are. Many use an elaborate network of freezers and specialised trucks and aircraft to move temperature-sensitive materials such as blood, stem cells and tissue around the world without compromising their efficacy. Its a delicate process, because a product can go from vital to useless within minutes of being removed from cold storage.

Potential investors are constantly calling Stirling Ultracold, whose freezer equipment is powering UPS freezer farms in Louisville, Kentucky, and the Netherlands, where vaccines will be stored. Theres not a day that goes by that an inquiry doesnt come in, said Dusty Tenney, Stirlings chief executive, who is running his Athens, Ohio, production lines around the clock.

Demand for Stirlings freezer engines the core component of its upright, under-the-counter and portable freezers has soared, and the estimated waiting time for new orders is six to eight weeks, the company said. On December 8, after multiple prospective investors studied the companys financial metrics in a due diligence process, Stirling received a capital injection of an undisclosed amount that it plans to use to buy new equipment and expand production.

In October, Blackstone, the private equity giant, invested $275 million in Cryoport, a Nashville, Tennessee company that specializes in shipping sensitive medical materials at freezing temperatures. Investors have also been bullish on Ember, the beverage-heating company that has developed a refrigerated medical shipping box with built-in GPS and already counts two Jonas Brothers and Brooklyn Nets forward Kevin Durant as shareholders.

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PCI Pharma recently changed ownership. The new investors, private-equity firm Kohlberg & Co. and Abu Dhabi, United Arab Emirates, sovereign-wealth fund Mubadala Investment Co., viewed the companys expertise in transporting pharmaceuticals globally during the pandemic as a potential benefit.

Cold-chain investors said they were drawn to the area well before the pandemic because of the boom in biologic drugs, which require blood, tissue and other vital materials to be transported at low temperatures. For now, though, the rush to develop and distribute Covid-19 vaccines has amped up investors enthusiasm.

In addition to Pfizer and Moderna, AstraZeneca, Johnson & Johnson and others are also developing vaccines that will require cold storage. Therefore, cold-chain infrastructure, which can be limited in rural or far-flung areas like southeastern Indiana and Hawaii, will be essential.

Shares of Cryoport, which ships biologic material at cryogenic temperatures a level of freezing, usually around minus 150 Celsius, at which cells and other living materials enter a quiescent state are up more than 180% this year. Already, the company has transported temperature-sensitive materials involved in 26 different Covid vaccines and treatments and has a long-term partnership with McKesson, a distributor of medical supplies that has been tapped by the US government to manage domestic vaccine distribution.

Jerrell Shelton, Cryoports chief executive, said he expected the company to be involved in the global distribution of the vaccine, but the details had not yet been determined. This is a massive, massive effort, and its going to strain the temperature-control supply chain throughout the world, he said.

Ram M. Jagannath, a senior managing director at Blackstone who oversees the firms investment in Cryoport, said that the cell and gene-based therapies market in which the company operates is likely to grow at an annualised rate of 50% for the next five years. The current pandemic has only served to increase interest and investment in these potentially lifesaving therapies, Jagannath said. We invested in this for the long run.

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Then there are companies like Ember, which is hoping to parlay its temperature-control technology currently used in a smart mug that keeps beverages at the users preferred drinking temperature into a shipping container for the Covid vaccine. Several years ago, Ember built a portable refrigerator for Mayo Clinic physicians trying to deliver vaccines to places where dry ice and cooling facilities were scarce.

We tested it, and we got huge positive feedback, said Clay Alexander, Embers chief executive.

That led to the creation of Embers cold box, which can ship medical products at standard refrigeration temperatures and generate its own electronic return labels on arrival a product it plans to take wider next year through a commercial partnership it signed recently. Investors in Ember are hoping that the technology will also come in handy as delivery of Covid vaccines becomes more widespread.

Much of the cold-chain infrastructure for pharmaceuticals was already in place in 2014, when veteran health care investor Matthew J. Jennings attended a gathering of the cold-chain industrys trade association in Chicago.

I was surprised at the size of the industry and the number of exhibitors searching for growth, said Jennings, an operating partner at Kohlberg who is now chairman of PCI Pharma. Growth, he said, has accelerated since then, and will likely benefit again as a result of Covid.

On November 20, a shipment of a Covid vaccine PCI Pharmas Haffar wouldnt say which one arrived at the companys headquarters as part of a dry run, escorted by armed US marshals.

The vials containing the vaccine were stored in a PCI refrigerator set between 2 and 8 degrees Celsius and monitored constantly. Once ready for packaging, the vials were removed from storage and brought to a machine where they were labelled and boxed before being returned to cold storage.

Haffar gave a tour recently of the companys Philadelphia building. Inside a walk-in cooler and wearing a long-sleeved gown and hairnet, he motioned to the surrounding shelves. They contained rows and rows of products that PCI packages, including drugs that treat Crohns disease and syringes that inject medicines directly into the eye.

The cold chain has been around forever, he said. The vaccine just made the sheer size of it bigger.

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The unsexy side of Covid-19 vaccines gets Wall Streets attention - Deccan Herald

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