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3D Printing Industry review of the year: February 2020 – 3D Printing Industry

The month of February 2020 saw industry leaders come together for TV SDs 2nd Additive Manufacturing Conference, alongside 3D printing-enabled medical breakthroughs and a landmark delivery of 3D printed parts within the maritime sector.

Read on for the standout developments of February 2020, which involved the likes of Renishaw, Wilhelmsen, Formlabs, COBOD, and Evonik.

TV SDs Additive Manufacturing Conference

February got underway with the 2nd TV SD Additive Manufacturing Conference, held in the heart of Bavaria, which brought together 3D printing experts, industry leaders, and academics to share their thoughts on the implementation of industrial additive manufacturing.

During the conference, standardization and digitization were singled out as the gateways to a fully automated additive manufacturing system in years to come in regards to material testing, quality assurance, part certification, and process chains.

Space-time research expands for AM

Meanwhile, researchers from the Delft University of Technology (TU Delft) developed a method to concurrently optimize 3D printed structures and the fabrication sequence that creates them, specifically in the wire arc additive manufacturing process (WAAM).

Recently awarded the ISSMO/Springer prize from the International Society of Structural and Multidisciplinary Optimization (ISSMO), the research can be explained using the example of a robot building a bridge in a futuristic scenario, where the bridge must maintain its mechanical strength as it is being built in order to support the weight of the robot.

Wilhelmsens landmark maritime delivery

Global maritime industry group Wilhelmsen delivered what it claimed to be a landmark commercial delivery of 3D printed parts to dry bulk shipping company Berge Bulk. The delivery was part of Wilhelmsens Early Adopter Program with additive manufacturing service bureau Ivaldi Group, which was launched in late 2019 and involved the supply of 3D printed spare parts on-demand to ships and other vessels.

This is just the beginning of the journey, and we are quickly expanding our offering, together with our key development partners, enabling our customers to benefit from the savings provided by 3D printing, digital inventory and on-demand localized manufacturing, said Hakon Ellekjaer, head of venture, 3D printing, at Wilhelmsen Ships Services.

Research roadmaps and material exploration

Midway through February, a worldwide collective of researchers from various universities and institutions came together to produce a roadmap for 3D bioprinting, which was published in Biofabrication.

Summarising the current state of bioprinting, including recent advances of the technology, present developments, and challenges, the paper envisioned how the technology could improve in the future. Topics covered in the paper ranged from cell expansion and novel bio-ink development to stem cell printing and organoid-based tissue development, in addition to bioprinting human-scale tissue structures and multicellular engineered living systems.

Elsewhere, research coming out of the Tokyo University of Science explored how water molecules react when they come into contact with the surface of graphene, revealing there is much to learn about the interaction between water and 3D printed materials.

Surface water on carbon nanomaterials such as graphene has attracted much attention because the properties of these materials make them ideal for studying the microscopic structure of surface water, saidProfessor Takahiro Yamamoto, leader of the study.

Advancing dental restorations

SLA 3D printer manufacturer Formlabs announced new materials from German dental 3D printing pioneer BEGO were to be used in Formlabs Form 3B and Form 2 resin printers. Using these systems, dental professionals are now able to 3D print temporary and permanent crowns and bridges directly for patients.

Widely regarded as a specialist in the sector, BEGO has been developing dental-specific 3D printing materials for over two decades. Now, Formlabs printing systems will use BEGOs materials to print permanent single crowns, inlay, onlays, and veneers, and temporary crowns and bridges.

Construction printing: Live

Danish 3D printing construction firm COBOD demonstrated its construction technology by 3D printing the walls of small four houses during the international Bautec construction exhibition in Berlin, between 18-21 February. The demo was completed using the companys BOD2 3D construction printer, and aimed to provide an un-cut example of its technology in action to Bautec visitors.

When you print live, it is not possible to hide anything, explained Henrik Lund-Nielson, COBOD CEO. With this live printing, we are documenting that our technology has the quality, robustness and stability to perform hour after hour, day after day.

Evoniks first 3D printing software tool

Towards the latter stages of February, German specialty chemicals company Evonik launched its first software tool for 3D printing, designed to help manufacturers select the appropriate additive manufacturing process for their desired part.

Developed by Israeli start-up Castor, in which Evonik invested in late 2019, the software aids users in their choices by taking into account the designs geometry, material, and financial analysis.

Renishaw lands Parkinsons study milestone

Rounding off the month on a positive note, UK-based engineering technologies firm Renishaw announced a milestone in a medical study seeking to help sufferers of Parkinsons disease, for which it developed a patented intraparenchymal drug delivery device using 3D printing.

Initial results of the study were promising and indicated predictable and accurate placement of the neuroinfuse device, as well as significant efficacy and safety of both the device and the drug, CDNF, which was developed by pharmaceuticals experts Herantis Pharma.

Renishaw has since concluded an extension to the study, which is currently the only platform to facilitate repeated, intermittent infusions into the parenchyma, and enables patients to receive the infusions in an out-patient setting.

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Featured image showsFabian Meyer-Brtz, head of 3D printing at Peri, showcasing the end result for the printing on February 19, 2020. Photo via COBOD.

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3D Printing Industry review of the year: February 2020 - 3D Printing Industry

Michigans Catholic bishops say 2 COVID-19 vaccines are OK morally but another is problematic – MLive.com

GRAND RAPIDS, MI Michigans seven Catholic bishops said COVID-19 vaccines by Pfizer and Moderna are morally permissible but raised concerns about AstraZencas vaccine using a cell line that originated from tissue of an aborted fetus.

Pfizer and Moderna have received emergency approval for use by the U.S. Food and Drug Association. Pfizers vaccine has already rolled out across the country while Moderna expects to begin shipping its vaccine on Sunday, Dec. 20.

AstraZencas vaccine along with a vaccine by Johnson & Johnson - is nearing its final trial stage.

The Catholic bishops issued a statement Saturday, Dec., 19, on what they called the morality of COVID-19 vaccines.

It is morally permissible to receive the vaccines developed by Pfizer and Moderna, the bishops said.

Neither of these vaccines have used cell lines originating in tissue taken from aborted babies in their design, development, and production. However, both the Pfizer and the Moderna vaccine did use such a cell line in the confirmatory testing. This connection to the abortion is very remote, however, and it is important to keep in mind that there are varying levels of responsibility. Greater moral responsibility lies with the researchers than with those who receive the vaccine, the bishops wrote.

The vaccine developed by AstraZeneca is more morally problematic, however, the bishops wrote.

It did utilize in the design, production, development, and confirmatory testing a cell line that originated from tissue taken from an aborted baby. This vaccine may be received only if there are no other alternatives. If one does not have a choice of vaccine and a delay in immunization may bring about serious consequences for ones health and the health of others, it would be permissible to accept the AstraZeneca vaccine.

Science Magazine said that at least five COVID-19 vaccine candidates use a fetal kidney cell line from a fetus aborted around 1972 or cells of an 18-week-old fetus that was aborted in 1985.

Dr. Deepak Srivastava, former president of the International Society for Stem Cell Research, told the Associated Press that the fetal cell lines were vital in developing vaccines for a range of viruses.

They are widely used in many aspects in biomedical science because they are so effective, he said. Whats important for the public to know even if they are opposed to the use of fetal cells for therapies, these medicines that are being made and vaccines do not contain any aspect of the cells in them, Srivastava said. The cells are used as factories for production.

In a column for the Heritage Foundation, which promotes conservative public policy, Dr. Melissa Moschella said she strongly opposes abortion but supported using the cell lines derived long ago from the tissue of aborted fetuses - to develop life-saving vaccines.

Cell lines (from one of the fetuses) are far removed from the unborn child from whose tissue they were initially derived. Such cell lines are immortal, meaning that, once developed, they continue to divide and reproduce themselves indefinitely. This means that the use of such lines does not necessarily create additional demand for new fetal tissue, Moschella wrote.

The bishops said the Congregation for the Doctrine of the Faith found vaccinations permissible because of the pandemics serious health risks.

Those who do not receive vaccinations have a moral responsibility to take steps to prevent spread of the virus, they said.

At this same time, we join our voices to call for the development of vaccines that have no connection to abortion. Our consciences must not be dulled, nor may we imply in any way that abortion is acceptable, the bishops said.

The statement was issued by Allen H. Vigneron, archbishop of Detroit, and bishops Paul J. Bradley of Kalamazoo; Earl A. Boyea of Lansing; John F. Doerfler of Marquette; Robert D. Gruss of Saginaw; Walter A. Hurley, apostolic administrator, of Gaylord; and David J. Walkowiak of Grand Rapids.

Read more:

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Michigans Catholic bishops say 2 COVID-19 vaccines are OK morally but another is problematic - MLive.com

How Researchers Are Making Do in the Time of COVID-19 – The Wire Science

Image: UN/Unsplash.

One of the astonishing aspects of the human response to the COVID-19 pandemic has been how quickly scientists pivoted to studying every facet of the virus in order to mitigate the loss of life and plan for a return to normalcy. At the same time, a lot of non-coronavirus research ground to a near halt.

With research labs and offices shuttered for all but essential workers, many scientists were stuck at home, their fieldwork and meetings canceled and planned experiments kicked down the road as they struggled to figure out how to keep their research programs going. Many took the opportunity to catch up on writing grants and papers; some in between caring for kids came up with strategic workarounds to keep the scientific juices flowing.

To gauge how researchers in different fields are managing,Knowable Magazine spoke with an array of scientists and technical staff among them a specialist keeping alive genetically important strains of fruit flies, the maintenance chief of an astronomical observatory working to keep telescopes safe and on standby during the lockdown, and a paediatrician struggling to manage clinical trials for a rare genetic disease. Here are a few slices of scientific life during the pandemic.

Agnieszka Czechowicz, Stanford University School of Medicine

Czechowicz is a paediatrician in Stanfords division of stem cell transplantation and regenerative medicine, where she manages a research group that develops new therapies and conducts clinical trials on rare genetic diseases.

Agnieszka Czechowiczs father suffers from severe Parkinsons disease. The coronavirus pandemic forced him to remain indoors and away from people, robbing him of the physical conditioning and social interactions he needs to cope with his disease. A recent fall left him in the hospital, bringing the additional worry that he might contract COVID-19 there and isolating him further.

For Czechowicz, his situation brought into sharp relief the challenges the coronavirus has forced upon those carrying out clinical trials, including those she is running, which involve patients traveling to hospitals around the country. Would I have him travel to any clinical site right now for a new Parkinsons treatment? she says. Absolutely not.

The pandemic forced Czechowicz to halt clinical trials she oversees for a rare genetic disease of children called Fanconi anAemia, a condition that impairs the bodys ability to repair damaged DNA and often leads to bone marrow failure and cancer. The treatment Czechowicz and colleagues are testing involves extracting blood-forming stem cells from the patients bone marrow, inserting a healthy copy of a missing or malfunctioning gene and then reinfusing those cells back into the patient.

Every aspect of what I do is massively impacted by the pandemic, Czechowicz says. One of her early-stage clinical trials involves testing the safety of the therapy. But during the initial shutdown which started in mid-March and lasted for two months her patients could not readily travel to Stanford for the necessary follow-up visits, and remote monitoring was difficult.

Theres special blood testing and bone marrow testing that we need to do. In particular, its critical to get the samples to make sure the patients, for example, arent developing leukAemia, she says. Theres no way to know that without really checking the bone marrow. She had to clear large hurdles to get her patients evaluated.

Another early-stage trial, designed to determine the effectiveness of the therapy, also had to stop enrolling new patients. Because speed is important when it comes to treating Fanconi anaemia the children are likely losing stem cells all the time any delay in treatment can be a source of great anxiety for their parents. Czechowicz had to explain to them why the trials were temporarily halted. It was really challenging to have these discussions with the families, she says.

With the easing of travel and workplace restrictions, the families began traveling to Stanford in June but with infections back on the rise, many families are becoming hesitant again, says Czechowicz. Fortunately, her trials are small, so she can guide each family through the process of safely resuming the trials and continuing with follow-up. Her own team also has to follow strict safety protocols. For example, even though her lab has 10 members, only two can be in the lab at any one time, and only one parent is allowed into the clinic with the child.

Not all clinical trials can pay such close attention to individual patients. Large trials with hundreds of patients can involve multiple sites and require much more monitoring, so resuming those remains difficult. Also, restrictions on working full bore are slowing the pipeline for new therapies. The impact of that, were not going to see for many years to come, Czechowicz says.

Abolhassan Jawahery, University of Maryland, College Park

Jawahery is a particle physicist and a member of LHCb, one of the main experiments at the Large Hadron Collider (LHC) at CERN, the particle physics laboratory near Geneva.

In December 2018, well before the coronavirus pandemic began, the LHC shut down for upgrades. Housed in a 27-kilometre-long tunnel about 100 meters underground, the LHC accelerates two beams of protons, one clockwise and one counterclockwise, and makes them collide head-on at four locations. There, four gigantic subterranean detectors ATLAS, CMS, LHCb and ALICE sift through the debris of particles created by the collisions, looking for evidence of new physics. (For example, ATLAS and CMS found the Higgs boson, the fundamental particle of the Higgs field, which gives all elementary particles their mass.)

For its next set of experiments, which aim to probe the properties of subatomic particles with greater precision, the LHC needed to increase the intensity of its proton beams. Consequently, the four detectors needed to be upgraded too, to handle the resultant higher temperatures and increased radiation at the sites of the particle collisions. The work was on track for a restart around May 2021 until the pandemic swept all the scientists careful plans away.

The LHC and its four detectors are each run by a separate collaboration. CERN, which manages the LHC, is hopeful it can restart the collider by February 2022. They think that they can get the accelerator going if there are no more major catastrophic events, says physicist Abolhassan Jawahery. But the impact on the four detectors is less clear.

For the LHCb upgrade, Jawaherys team at the University of Maryland had been working on building about 4,000 extremely sensitive electronic circuit boards. These boards have to be burned in before they can be sent to CERN. We put them in an oven, literally cooking the boards and then running extensive tests in order to get them ready so that we can put them in the accelerator and run them for 10 to 20 years, says Jawahery. And none of that could be done during the pandemic shutdown.

The team resumed its work in June, but with restrictions put in place by the state of Maryland. Jawahery runs two labs, and for months was allowed only two people at a time in one lab and three in the other, making progress extremely slow. Still, his team is fortunate that it does not depend on supplies from countries hit hard by the coronavirus. Other labs werent so lucky. Scientists in Milan, for example, built some electronics and detector components for the LHCb, and a lab at Syracuse University in New York built sensors that relied on shipments from Milan. When Milan was completely closed down at the height of the pandemic, Syracuse, too, stopped working on Milan-dependent components.

For Jawahery the lockdown had a silver lining. The LHCs most recent run had produced about 25 gigabytes of data per second but his team had found little time to analyse any of it before the pandemic. We were complaining that we were spending all our time building the new instrument and the data keeps on coming, he says. When he and his team were locked out of their labs, they turned to their data backlog. We could do actual physics, he says. We are already getting ready to publish some papers.

Gordon Gray, Princeton University

Gray is a professionalDrosophila specialist in the department of molecular biology.

Gordon Gray has been called the chef de cuisine of Princetons fly kitchen, where he has been feeding flies for 46 years. He concocts meals for millions of fruit flies, at least 150 litres each week. When the pandemic hit in March and universities around the world shut down, Princeton deemed Grays work an essential service: The Drosophilafruit flies could not be allowed to die off.

Princetons flies include mutant and transgenic strains everything from ones that allow researchers to study the genes that influence normal development of a fly embryos organs, to those that have cancer-causing mutations. If the flies starved, researchers would need months or years to recreate these strains, says Princeton molecular biologist Elizabeth Gavis. And often, as techniques in molecular biology improve, the biologists reexamine flies they had studied earlier to get a more fine-grained understanding, making it worthwhile to preserve the strains.

Normally, if a lab had to shut down, researchers would send their flies to stock centres, such as one at Bowling Green State University in Ohio, that preserve the flies as part of their genetic library. But the stock centres couldnt handle Princetons flies, so Gray found himself on his own. Its basically catch as catch can with regards to the various labs here, just to keep things operational, he says.

For months, university pandemic restrictions have allowed only one person to be in Grays kitchen at a time. This has caused problems. Before the pandemic began, Gray, who is in his late 60s, had started training someone as a backup. But because of the one-person restriction, Gray and his trainee havent been able to work together. Gray envisions doing so soon, while wearing masks, keeping nearly 12 feet apart and communicating using hand signals.

To whip up a batch of fly food, or media, Gray uses a 50-litre steel cauldron, to which is attached a mixer that looks like an outboard motor. Gray fills the cauldron with water and adds agar, sugars, yeasts, salts and cornmeal, then brings it to a boil, all the while stirring watchfully. You dont want it to boil over, because when it does you wind up with a gigantic pancake on the floor, which you have to scoop up immediately because it gels, he says. Once the suspension cools to the right temperature, Gray adds an acid to inhibit mould, then dispenses precise amounts of the media into bottles and vials.

Even before the pandemic, Grays kitchen was isolated, to keep errant fruit flies from contaminating the pristine media. But at least he could work regular hours, because he knew the rhythms of the 10 or so fly labs he cooked for. That has changed. Labs, restricted to two occupants at a time, are now working seven days a week on rotating shifts. Gray comes in to work at all hours, because he cannot predict when each batch of fly food will run out and hell need to cook more.

He tries to work mostly at night to avoid coming into contact with others. But he still worries for his health, given his asthma and age-related risk. The relentless pandemic is taking a toll. Its exhausting, he says. It doesnt help not knowing when we will return to a sense of normalcy.

Celeste Kidd, University of California, Berkeley

Kidd is a child developmental psychologist who uses behavioural tests and computational methods to understand how children acquire knowledge.

When UC Berkeley locked down in March, Celeste Kidd found herself closeted at home, dealing simultaneously with virtual meetings and her three-year-old son. During the early days of the pandemic, Kidd kept a supply of treats handy, and when her toddler came up to her during a meeting shed sneak him some under the desk. But she hadnt accounted for how long the pandemic would last. It turns out thats not a good strategy, long term, she says. I was very literally rewarding him for bad behaviour.

Kidds son soon learned that acting up during her meetings meant more candy. I knew that would happen. I did it anyway because I didnt have the bandwidth to come up with a better solution, she says. But Kidd knew from her own research that children are also extremely flexible and can unlearn behaviours. Eventually, she had a chat with her son. First, she admitted to him that she had made a mistake by giving him candy when he disrupted her meetings, and that was bad of her. Then she brought in new rules: no candy for misbehaving and misbehaviour could even mean no treats for the rest of day. We had some meltdown moments, says Kidd. But he gets it now and he doesnt do those things.

Her son may be the only child Kidd gets to interact with during the pandemic. Thats a huge loss for her research, because the bulk of her work focuses on young children. In normal times, families would bring their children to her lab, where her research team would track their gaze as they watched videos. In one study, for example, infants about seven to nine months old would look away (demonstrating lack of interest) when the events in the video were either too complex or too simple, suggesting that infants use their cognitive resources for stimuli that have just the right amount of information.

Such work, of course, requires the presence of parent, child and researchers, all in the same room. None of that is going to happen anytime soon, she says. Those families are not going to feel comfortable coming in for a while.

Kidd is also concerned about the impact of the pandemic on younger scientists. One of her undergraduate students had spent six months working on a study aimed at exploring the complexity of kids play patterns using physical objects and their relation to working memory and other cognitive resources. The university had approved the protocol, but shelter-in-place orders went into effect the week the first child was to come for the experiment. I feel so bad for her as a young scientist, to have done all this hard work and then right when you get to the fun part, which is collecting the data and finding out if her ideas have lasting merit, she doesnt get to do that part, Kidd says.

The situation might be even worse for grad students and postdocs. All of them are experiencing a big blow to morale in general, because there is so much uncertainty about what the future holds, she says. University budget cuts mean fewer slots for graduate students and fewer jobs for postdocs. Its very hard to stay motivated and get things done when youre not sure if there will be a payoff in the future, says Kidd. Thats literally a study that we ran in the lab so were all acutely aware of it.

Maxime Boccas, ESO Paranal Observatory

Boccas is the head of maintenance, support and engineering at the European Southern Observatorys Paranal Observatory in Chile.

When the massive domes of the Very Large Telescope, a constellation of four 8-meter-class telescopes atop Mount Paranal in Chiles Atacama Desert, open to the night sky each evening and the telescopes get ready for observations, its like a dragon waking up.

When the pandemic hit in March, the dragon on Mount Paranal closed its eyes to the cosmos and slept the first shutdown in its 20-year history, which included a major earthquake in 2010 that paralyzed much of the rest of Chile. For those who had to leave Paranal, it was like being sent away from home. We spend 40% of our life here, says Maxime Boccas, who oversaw the process of ensuring an orderly shutdown of the sites scientific and technical facilities. We work and sleep here, and we stay here eight days in a row. Some of Boccass colleagues have been doing that for 20 to 25 years. Leaving Paranal was like leaving their second home. That was a weird feeling.

The skeleton staff just 20 of the normal 150 or so people remained on site kept the observatory safe, ensuring that essential systems continued working: computers that astronomers were accessing remotely, the fire detection system and the earthquake protection system essential for protecting the 8-meter-wide primary mirrors from Chiles frequent quakes. The mirrors will likely never be made again, says Boccas. All the factories that cast and polished them are dismantled. If we lost a mirror, it would take between 5 and 10 years to build up the factory again and fabricate it. So each mirror has an airbag a tube that inflates around it when the system detects tremors and other protections.

During the shutdown, astronomers kept their fingers crossed. They were anxious that no big thing, like a supernova in our galaxy, would explode, Boccas says. The heavens have been quiet, but the six-month shutdown harmed research that involves continuously monitoring the same patch of the sky for transient phenomena such as gamma ray bursts. It creates a hole in their science program, says Boccas.

The observatory began a slow return to normalcy on September 9. Boccas is overseeing the reawakening of each telescope, one at a time. The staff still less than full strength is now working in shifts that have doubled from 8 to 15 days to limit the amount of travel to and from the site. The four large telescopes are now up and running again, and Boccas hopes they will be back to working together as one by the end of January.

Boccas, his crew and a few lucky astronomers are glad to be back at Paranal. It really feels like a family and I think everyone has noticed that, he says. Even in the kitchen, they have to cook for 30 people instead of 150, so the quality of the food is different, its slightly better.

But even as people return to the observatory, Boccas worries about long-term effects of the shutdown. Given the reduced staff, he has had to cut down on the frequency of preventive maintenance tasks, such as changing belts and lubricating motors, potentially shortening the lifetime of some components. We will not know until six months, a year or three years from now, he says.

This article is part ofReset: The Science of Crisis & Recovery, an ongoing series exploring how the world is navigating the coronavirus pandemic, its consequences and the way forward. Reset is supported by a grant from the Alfred P. Sloan Foundation.

Anil Ananthaswamy is a science journalist who enjoys writing about cosmology, consciousness and climate change. Hes a 2019-20 MIT Knight Science Journalism fellow. His latest book is Through Two Doors at Once. http://www.anilananthaswamy.com.

This article originally appeared in Knowable Magazine, an independent journalistic endeavour from Annual Reviews.

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How Researchers Are Making Do in the Time of COVID-19 - The Wire Science

Stem cells in drug development – Nordic Life Science

The high cost and uncertain outcomes of developing new drugs has taken a toll on research over the past several years. Few companies can take the hit of investing hundreds of thousands of dollars in research and testing, only to see dangerous side effects emerge during the final stages, human clinical trials.

The pursuit of more accurate, less costly testing methods has led many companies to stem cells, which can be coaxed into developing into cells of human organs such as the heart and liver and provide a more accurate, less expensive process for testing. Researchers have been able to generate cells in the laboratory that reach the gold standard required by the pharmaceutical industry to test drug safety. Now, drug companies are increasingly adopting stem cells for research, for testing the toxicity of drugs and identifying potential new therapies.

Id say there have been a lot of advances in past five years, but its still in its early days, said Dr. Steven Minger, chief scientist for cellular sciences, GE Healthcare Life Sciences. There is still a concern about how good the cells are and how they will react. Weve gone a long way and have a lot of high-quality data, but pharmaceutical companies still have to decide if this is superior to the method they have been using for 40-50 years.

Standard procedure for decades has been to test new drugs on the organs of animals, such as rabbits. But in many cases, there were no adverse reactions in the animals, so companies proceeded to clinical trials, only to discover then the drug caused side effects on human organs, forcing the company to abandon the drug or launch costly research to find a solution.

Now some new medications are being tested for safety on differentiated cells generated from humanpluripotent cell lines, which are stem cells capable of developingintoanytypeofcellortissueexcept thosethatformaplacentaorembryo. Not only is there an endless supply of them, but they provide a more consistent basis for testing. Human cells are much more predictable and predictable certainly lowers risks, Minger noted. Not to mention saving money; developing a new compound can cost as much as $27 million, he added.

Companies were spending millions of dollars to fail, Minger continued, This [stem cell testing] will make for safer, cheaper, better drugs. The sooner companies are aware of problems with a drug, the easier it is to address them. They can bail fast, bail early or get rid of the toxic compounds as quickly as possible, he said. And just because a drug comes up bad, doesnt mean the drug is bad. It gives you more options early. The fact that you have data early means you have time to do something with it. Later on, you dont what to spend billions to find out the problem.

Cells currently available for use in testing are heart muscle and liver, which are the organs where 80 percent of drug failures occur, Minger added. Drug companies get the cells from firms such as Swedens Takara Bio Europe AB, which produces heart muscle cells and liver cells for drug and biotechnology companies as well as universities. They allow for early testing on human material; you have quality controlled material from the same source, said Kristina Runeberg, site head/senior director, business development, for Takara Bio Europe AB. Heart and liver cells were considered most important and developed first, but she expects neural cells to come next, and researchers also are working on beta cells, which are in the pancreas.

The results from stem cell testing so far are convincing companies and regulatory agencies that this is the new best practice. The U.S. Federal Drug Administration (FDA) is expected to require at least some drugs to undergo stem cell testing as part of the approval process in the not so distant future.

We have huge amounts of data and believe they are superior to animal cells; now through a number of organizations working together with the FDA, there is starting to be a consensus built that stem cells have a huge potential and should be the new standard for how pharmaceutical compounds are assessed on a safety basis, according to Minger.

Future developments include using stem cells to test for long-term chronic toxicity in certain drugs, which requires keeping the same culture for longer periods of time, Runeberg said. Researchers also are working on new ways to identify hazards and test toxicity, added Minger.

There are 220 different cell types, and it is theoretically possible to make them all, Runeberg added. The field has started with the most important ones. In the future, more and more will be developed and more companies will be commercially involved.

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Stem cells in drug development - Nordic Life Science

Global Cell Culture Market by Product, Application, End-user and Region – Forecast to 2025 – PRNewswire

DUBLIN, Dec. 18, 2020 /PRNewswire/ -- The "Global Cell Culture Market by Product (Consumables [Media, Serum, Vessels], Equipment [Bioreactor, Centrifuge, Incubator, Autoclave]), Application (Therapeutic Proteins, Vaccines, Diagnostics, Stem Cells), End-user (Pharma, Biotech) and Region - Forecast to 2025" report has been added to ResearchAndMarkets.com's offering.

The global cell culture market is projected to reach USD 33.1 billion by 2025 from USD 19 billion in 2020, at a CAGR of 11.8% during the forecast period.

The growth of this market is majorly driven by the growing awareness about the benefits of cell culture-based vaccines, increasing demand for monoclonal antibodies (mAbs), funding for cell-based research, growing preference for single-use technologies, and the launch of advanced cell culture products. On the other hand, the high cost of cell biology research and the lack of proper infrastructure for cell-based research activities are the major factors restraining this market's growth.

Based on product, the consumables segment holds the largest market share during the forecast period

Based on product, the cell culture market is segmented into equipment and consumables. The consumables segment accounted for the largest market share in 2019 and is expected to register the highest CAGR during the forecast period. The dominant share and high growth of the consumables segment can be attributed to the repeated purchase of consumables and increased funding for cell-based research.

Based on application, the biopharmaceutical production segment is expected to register the highest CAGR during the forecast period

Based on application, the cell culture market is categorized into biopharmaceutical production, stem cell research, diagnostics, drug screening & development, tissue engineering and regenerative medicine, and other applications. The biopharmaceutical production application segment is expected to register the highest CAGR during the forecast period.The high growth of this segment is attributed to the commercial expansion of major pharmaceutical companies, growing regulatory approvals for the production of cell culture-based vaccines, and the increasing demand for monoclonal antibodies (mAbs).

Pharmaceutical & Biotechnology companies end-user segment is expected to grow at the highest CAGR in the cell culture market during the forecast period

Based on end-users, the cell culture market is segmented into pharmaceutical & biotechnology companies, academic & research institutes, hospitals and diagnostic centers, and cell banks. The pharmaceutical & biotechnology companies segment is expected to witness the highest growth during the forecast period. The growing use of single-use technologies, the increasing number of regulatory approvals for cell culture-based vaccines, and the presence of a large number of pharmaceutical players in this market are some of the factors driving the cell culture market for this end-user segment.

North America is expected to account for the largest share of the cell culture market in 2019

In 2019, North America accounted for the largest share of the cell culture market, followed by Europe, the Asia-Pacific, Latin America, and the Middle East & Africa. The large share of this market segment can be attributed to the growing regulatory approvals for cell culture-based vaccines, technological advancements, and growth in the biotechnology & pharmaceutical industries in the region are the key factors driving the growth of the cell culture market in North America.

Key Topics Covered:

1 Introduction

2 Research Methodology 3 Executive Summary

4 Premium Insights 4.1 Cell Culture: Market Overview 4.2 Asia-Pacific: Cell Culture Market Share, by End-user and Country (2019) 4.3 Cell Culture Market: Geographic Growth Opportunities 4.4 Regional Mix: Cell Culture Market 4.5 Cell Culture Market: Developed Vs. Developing Markets

5 Market Overview 5.1 Introduction 5.2 Market Dynamics 5.2.1 Market Drivers 5.2.1.1 Growing Awareness About the Benefits of Cell Culture-Based Vaccines 5.2.1.2 Increasing Demand for Monoclonal Antibodies 5.2.1.3 Funding for Cell-Based Research 5.2.1.4 Growing Preference for Single-Use Technologies 5.2.1.5 Launch of Advanced Cell Culture Products 5.2.1.6 Growing Focus on Personalized Medicine 5.2.2 Market Restraints 5.2.2.1 High Cost of Cell Biology Research 5.2.2.2 Lack of Infrastructure for Cell-Based Research in Emerging Economies 5.2.3 Market Opportunities 5.2.3.1 Growing Demand for 3D Cell Culture 5.2.3.2 The Growing Risk of Pandemics and Communicable Diseases 5.2.3.3 Emerging Economies 5.3 COVID-19 Impact on the Cell Culture Market 5.4 Value Chain Analysis 5.5 Supply Chain Analysis 5.6 Ecosystem Analysis 5.7 Regulatory Analysis

6 Cell Culture Market, by Product 6.1 Introduction 6.2 Impact of the COVID-19 on the Cell Culture Market 6.3 Consumables 6.3.1 Sera, Media, and Reagents 6.3.1.1 Media 6.3.1.1.1 Serum-Free Media 6.3.1.1.1.1 Lack of Sera Eliminates the Risk of Contamination by Viruses 6.3.1.1.2 Classical Media & Salts 6.3.1.1.2.1 Classical Media is Commonly Used in Virology, Vaccine Production, and Primary Tissue Explant Culture 6.3.1.1.3 Stem Cell Culture Media 6.3.1.1.3.1 Stem Cell Culture Media to Witness the Highest Growth in the APAC Market During the Forecast Period 6.3.1.1.4 Specialty Media 6.3.1.1.4.1 Specialty Media is Suitable for the Growth of Selective Cell Types 6.3.1.2 Reagents 6.3.1.2.1 Growth Factors 6.3.1.2.1.1 Growth Factors are Unique Cell Signaling Molecules That Help in Cell Proliferation & Development 6.3.1.2.2 Supplements 6.3.1.2.2.1 Supplements Such as Amino Acids Play a Key Role in Inducing Cell Growth 6.3.1.2.3 Buffers & Chemicals 6.3.1.2.3.1 Chemical Buffers are Widely Used, But It Can be Toxic at Higher Concentrations 6.3.1.2.4 Cell Dissociation Reagents 6.3.1.2.4.1 Dissociation Reagents Can be Enzymatic or Non-Enzymatic 6.3.1.2.5 Balanced Salt Solutions 6.3.1.2.5.1 Balanced Salt Solutions Find Wide Applications in Life Sciences 6.3.1.2.6 Attachment & Matrix Factors 6.3.1.2.6.1 The Development of Cells is Dependent on Attachment Factors 6.3.1.2.7 Antibiotics/Antimycotics 6.3.1.2.7.1 The Possibility of Contamination Risks Make the Long-Term Use of Antibiotics/Antimycotics Conditional 6.3.1.2.8 Contamination Detection Kits 6.3.1.2.8.1 Contamination Detection Kits Provide Rapid Results 6.3.1.2.9 Cryoprotective Reagents 6.3.1.2.9.1 Cryoprotective Reagents Protect Tissues/Cells from Damage due to Freezing 6.3.1.2.10 Other Cell Culture Reagents 6.3.1.3 Sera 6.3.1.3.1 Fetal Bovine Sera (FBS) 6.3.1.3.1.1 Use of FBS is Now Restricted due to Regulatory Guidelines 6.3.1.3.2 Adult Bovine Sera (ABS) 6.3.1.3.2.1 ABS is a Cost-Effective Alternative to FBS and is Used as a Biochemical Reagent in IVD 6.3.1.3.3 Other Animal Sera 6.3.2 Vessels 6.3.2.1 Roller/Roux Bottles 6.3.2.1.1 Roller Bottles Offer an Economical Means of Cultivating Large Cell Volumes 6.3.2.2 Cell Factory Systems/Cell Stacks 6.3.2.2.1 Cell Stacks Require Special Handling Equipment and Skilled Expertise 6.3.2.3 Multiwell Plates 6.3.2.3.1 Larger Well Formats Allow for Greater Culture Volumes 6.3.2.4 Flasks 6.3.2.4.1 Disposable Flasks are in Greater Demand Among End-users 6.3.2.5 Petri Dishes 6.3.2.5.1 The Wide Usage of Petri Dishes is Attributed to Ease of Use 6.3.3 Bioreactor Accessories 6.4 Equipment 6.4.1 Supporting Equipment 6.4.2 Bioreactors 6.4.3 Storage Equipment

7 Cell Culture Market, by Application 7.1 Introduction 7.2 Impact of the COVID-19 on the Cell Culture Market 7.3 Biopharmaceutical Production 7.3.1 Therapeutic Proteins 7.3.1.1 Growing Applications of Recombinant Proteins to Drive the Growth of this Segment 7.3.2.1 Rising Incidence of Disease Outbreaks to Drive the Market Growth for Vaccine Production 7.4 Diagnostics 7.4.1 The Growing Risk of Viral Infections Drives the Uptake of Cell Culture Products for Diagnostics 7.5 Drug Screening & Development 7.5.1 Increasing Adoption of Cell-Based Assays in R&D Activities to Drive Segment Growth 7.6 Stem Cell Research 7.6.1 Increasing Stem Cell Research Activities & Investments Drive Segment Growth 7.7 Tissue Engineering and Regenerative Medicine 7.7.1 Increasing Funding for Regenerative Medicine Boosts Segment Growth 7.8 Other Applications

8 Cell Culture Market, by End-user 8.1 Introduction 8.2 Impact of the COVID-19 on the Cell Culture End-User Market 8.3 Pharmaceutical & Biotechnology Companies 8.3.1 Growing Regulatory Approvals for Cell-Culture Based Vaccines Drives Segment Growth 8.4 Hospitals and Diagnostic Laboratories 8.4.1 Increasing Applications of Cell Culture for the Diagnosis of Various Diseases to Drive Segment Growth 8.5 Research & Academic Institutes 8.5.1 Increasing Government Funding for Research Projects and the High Prevalence of Cancer to Drive Growth for this End-User Segment 8.6 Cell Banks 8.6.1 Increasing Awareness of Preserving Stem Cells to Drive Segment Growth

9 Cell Culture Market, by Region 9.1 Introduction 9.2 COVID-19 Impact on the Cell Culture Market 9.3 North America 9.5 Asia-Pacific 9.6 Latin America 9.7 Middle East and Africa

10 Competitive Landscape 10.1 Overview 10.2 Competitive Scenario 10.2.1 Partnerships, Agreements, and Collaborations (2020) 10.2.2 Product Launches & Upgrades (2020) 10.2.3 Expansions (2020) 10.2.4 Acquisitions (2019-2020)

11 Company Evaluation Matrix and Company Profiles 11.1 Company Evaluation Matrix Definition & Methodology 11.2 Competitive Leadership Mapping (2019) 11.2.1 Stars 11.2.2 Emerging Leaders 11.2.3 Pervasive Companies 11.2.4 Emerging Companies 11.3 Market Share Analysis, 2019 11.4 Company Profiles 11.4.1 Thermo Fisher Scientific Inc. 11.4.2 Merck KGaA 11.4.3 Becton, Dickinson & Company 11.4.4 Corning Incorporated 11.4.5 Danaher Corporation 11.4.6 Eppendorf AG 11.4.7 Fujifilm Irvine Scientific, Inc. (Acquired by Fujifilm Corporation) 11.4.8 Lonza Group AG 11.4.9 Sartorius AG 11.4.10 Cellgenix GmbH 11.4.11 Miltenyi Biotec 11.4.12 Stemcell Technologies, Inc. 11.4.13 Himedia Laboratories 11.4.14 Invivogen 11.4.15 Infors AG 11.4.16 Promocell 11.4.17 Pan Biotech GmbH 11.4.18 Seracare Life Sciences Incorporation 11.4.19 Caisson Labs 11.4.20 Solida Biotech GmbH

12 Appendix 12.1 Insights from Industry Experts 12.2 Discussion Guide 12.3 Knowledge Store: The Subscription Portal 12.4 Available Customizations

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Global Cell Culture Market by Product, Application, End-user and Region - Forecast to 2025 - PRNewswire

Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels – PipelineReview.com

Details Category: DNA RNA and Cells Published on Friday, 18 December 2020 13:05 Hits: 509

- New opportunities for the development of NK-antibody combination therapies

- Significant positive effect on production time of Glycostem's lead product oNKord, and future CAR-NK and TCR-NK therapies

OSS, The Netherlands I Dec. 17, 2020 I Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE: Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels - PipelineReview.com

EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan – BioSpace

Dec. 14, 2020 10:00 UTC

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, today announced the appointment of Bo Zhang, Ph.D., as Head of the US Subsidiary, and Kehua Fan, M.D., as Head of Business Development. Both will report to Dr. Dong Wei, CEO of EdiGene.

Our company and R&D portfolio are entering into an exciting phase, as evidenced by the recent close of Series B financing and submission of the first gene editing product IND in China, said Dong Wei, Ph.D.CEO of EdiGene, Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. We are delighted to have Dr. Zhang and Dr. Fan join us at this significant stage of growth. Their extensive experience and proven track record in advancing innovative therapies, in addition to strong leadership skills, will help us to strengthen our portfolio and accelerate technology translation to help patients in need.

Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. Prior to joining EdiGene, he was Vice President of KLUS Pharma and focused on cell therapy and new technologies. Before that, he was Director of Development at Cobalt Biomedicine leading CAR-T and other cell/gene therapy programs, and R&D Director at OvaScience developing stem cell-based products. Prior to that, he held various oncology research and development positions at Merrimack Pharmaceuticals and Archemix. Dr. Zhang completed his postdoctoral fellowship at Harvard Medical School/Boston Childrens Hospital. He received his B.S. degree from Henan Normal University, M.S. degree from Chinese Academy of Sciences and Ph.D. from University of New Hampshire.

Dr. Kehua Fan has over 15 years of Business Development, Clinical Development of innovative drugs and other healthcare industry experience with MNCs and biotech companies. Before EdiGene, she served as Head of Strategy and Partnership at Junshi Biosciences, in charge of pipeline development strategy focus on oncology, autoimmune and metabolic diseases along with external partnership. Before that, she held positions in business development, clinical development strategy and operation on various therapeutic areas at Quintiles, GSK, Sanofi and Pfizer. She started her career as a General Surgeon at Zhongshan Hospital of Chongqing. She received a masters degree in Cardiovascular Pharmacology from West China Medical Center of Sichuan University and a bachelors degree in Clinical Medicine from Soochow University.

About EdiGene, Inc EdiGene is a biotechnology company focused on leveraging the cutting-edge genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with subsidiaries in Guangzhou, China and Cambridge, Massachusetts, USA. More information can be found at http://www.edigene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201214005267/en/

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EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan - BioSpace

Global Primary Antibodies Market To Reflect Impressive Growth Rate by 2028||Leading Players-Thermo F – PharmiWeb.com

Global Primary antibodies MarketIndustry Trends and Forecast to 2028 focuses on the major drivers and limitations for the key players. These research report also provides Comprehensive analysis of the market share, segmentation, revenue forecasts and geographic regions of the market. The Primary antibodies market research report is a professional and in-depth study on the current state of Primary antibodies Industry. Report Carrying 350 pages,60 Figures And220 Tables in it.

This report studies the Primary antibodies market. Management consulting is the practice of assist organizations to improve their development, performance, operating primarily through the analysis of existing organizational problems and the development of plans for improvement. Organizations may draw upon the services of management consultants for a number of reasons, including gaining external (and presumably objective) advice and access to the consultants specialized expertise

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Primary antibodies market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Analysis analyses the market for growth in the above forecast timeframe at a CAGR of 7.70%. Increasing levels of investment in research and development activities will further create lucrative opportunities for market growth.

The major players covered in the primary antibodies market report are

Global Primary Antibodies Market Scope and Market Size

Primary antibodies market is segmented on the basis of type, technology, source, research area, application, end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Based on type, the primary antibodies market is segmented into monoclonal antibodies, and polyclonal antibodies.

On the basis of technology, the primary antibodies market is segmented into immunohistochemistry, immunofluorescence, western blotting, flow cytometry, immunoprecipitation,ELISA, and other technologies.

Based on source, primary antibodies market is segmented into mouse, rabbit, goat, and other sources.

On the basis of research area, the primary antibodies market is segmented into infectious diseases, immunology,oncology, stem cells, neurobiology, and others.

Based on application, the primary antibodies market is segmented into proteomics, drug development, and genomics.

Primary antibodies market has also been segmented based on the end user into pharmaceutical and biotechnological companies, academic and research institutes, and contract research organizations.

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Primary Antibodies Market Country Level Analysis

Primary antibodies market is analysed and market size insights and trends are provided by country, type, technology, source, research area, application and end user as referenced above.

The countries covered in the primary antibodies market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

The U.S. dominates the North America primary antibodies market due to the growing number of stem cell, biomedical and cancer research along with increasing occurrences of chronic disorders in the region, while Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2021 to 2028 due to the surging levels of investment on research and development activities in the region.

Strategic Key Insights Of The Primary Antibodies Report: Production Analysis Production of the Patient Handling Equipment is analyzed with respect to different regions, types and applications. Here, price analysis of various Primary antibodies Market key players is also covered. Sales and Revenue Analysis Both, sales and revenue are studied for the different regions of the Primary antibodies Market. Another major aspect, price, which plays an important part in the revenue generation, is also assessed in this section for the various regions. Supply and Consumption In continuation of sales, this section studies supply and consumption for the Primary antibodies Market. This part also sheds light on the gap between supply and consumption. Import and export figures are also given in this part.

Competitors In this section, various Primary antibodies industry leading players are studied with respect to their company profile, product portfolio, capacity, price, cost, and revenue. Analytical Tools The Primary antibodies Market report consists the precisely studied and evaluated information of the key players and their market scope using several analytical tools, including SWOT analysis, Porters five forces analysis, investment return analysis, and feasibility study. These tools have been used to efficiently study the growth of the major industry participants. The 360-degree Primary antibodies overview based on a global and regional level. Market share, value, volume, and production capacity is analyzed on global, regional and country level. And a complete and useful guide for new market aspirants Facilitates decision making in view of noteworthy and gauging information also the drivers and limitations available of the market.

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Drivers:Global Primary Antibodies Market

Increasing levels of investment in research and development activities will further create lucrative opportunities for market growth.

Increasing number of stem cell and neurobiology research, rising academicresearchand industry collaborations, growing availability of the technologically advanced products, increasing focus on the biomarker discovery are some of the major as well as impactful factors which will likely to augment the growth of the primary antibodies market in the projected timeframe of 2021-2028.

On the other hand, increasing number of applications from emerging economies along with rising demand forpersonalized medicinesand protein therapeutics which will further contribute by generating immense opportunities that will led to the growth of the primary antibodies market in the above mentioned projected timeframe.

Customization Available :Global Primary Antibodies Market

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Global Primary Antibodies Market To Reflect Impressive Growth Rate by 2028||Leading Players-Thermo F - PharmiWeb.com

US gets more help in raging battle against COVID-19 as FDA authorizes Moderna vaccine, the second allowed for emergency use – USA TODAY

The FDA has authorized Moderna's COVID-19 vaccine for emergency use in the U.S. The first shots of the vaccine are expected to be given Monday. USA TODAY

CAMBRIDGE, Mass. Americans will soon have access to a second COVID-19 vaccine.

Stephen Hahn, commissioner of the U.S. Food and Drug Administration, granted emergency authorization Fridayto a vaccine made by Moderna,a week after giving similar clearance to one made by Pfizer and its German collaborator, BioNTech.

His is "authorizing" rather than approving the vaccine, because longer-term research is needed to meet the full standards for approval, which officials don't want to wait for during the public health emergency.

The speedy path to authorization was possible because the agencycut through regulatory red tape,Hahnsaid at a Friday night press conference. "We worked quickly based onthe urgency of this global pandemic ... we have not cut corners."

The announcementmakesthe U.S.the first country to authorize two COVID-19 vaccines that demonstrate "clear and compelling efficacy, Dr.Peter Marks director of the Center for Biologics Evaluation and Research at the FDA said during the press conference.Marks said it isanother milestone as we work to end the COVID-19 pandemic.

The move comes a day afterthe U.S. reported its 17 millionth case of COVID-19and an independent advisory committee reviewed data from human trials of Moderna's mRNA-1273 vaccine, deciding its benefits outweighed its risks. The vaccine, according to a trial that included 30,000 volunteers,protected more than94% of recipients from active disease, without causing major safety concerns.

Trucks will begin moving the vaccine this weekend, with the first of 5.9 million already manufactured Moderna shots expected to be given on Monday.

Your vaccine questions, answered:I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'

In this special edition episode of States of America, experts answer the biggest questions Americans have about the vaccine, side effects, how it's getting to you and more. USA TODAY

It's a triumphant moment for the 10-year-old Cambridge, Massachusetts, biotech companythat until nowhad never brought a product to market.

Now, both its vaccine and the one byPfizer-BioNTecharepoised to change the course of the worst pandemic in a century.

The virus that causes COVID-19 hasswept the world and particularly devastated the United States, which accounts for 4% of the world's populationbut nearly 23%of its COVID-19 cases and 19%of its deaths.

During the current winter surge, anAmerican is reported dead about every 34 seconds from the virus, and 150 are diagnosed every minute.

But it will take time to roll out vaccine across the country and the world, achieving the 70% protection from both vaccination and natural disease that experts say will be needed to stop widespread infections.

In this file photo taken on November 18, 2020 shows a syringe and a bottle reading "Vaccine Covid-19" next to the Moderna biotech company logo.(Photo: JOEL SAGET, AFP via Getty Images)

Moderna, which developed its vaccine in collaboration with government scientists,says it will be able to deliver 20 million doses of its vaccine by the end of December. Another 80 million will be available in the first few months of 2021, under a contract signed in Augustthat brought the U.S. government's direct financial backing of the companyto $2.5 billion.

"It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccine's rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public," Dr. Francis Collins, director of the National Institutes of Health, said Friday.

Just last week, the government closed a deal for a second 100 million doses to be delivered in the second quarter of next year, bringing taxpayers' total investment in mRNA-1273 up to$4.1 billion.

Another candidate vaccine, from Johnson & Johnson, fully enrolled its large-scale humantrial Thursdayand expects to report its first safety and effectiveness data in January.

A fourth, created by AstraZeneca and Oxford University, is a few weeks behind, and a fifth candidate, by vaccine developer Novavax ofGaithersburg, Maryland, is expected to begin its major U.S. trial shortly.

If all or most of these come through, there shouldbe plenty of vaccine by the endof next summer to cover every American who wants one.

"It's just incredible science and human achievement,"said Dr. Steven Joffe, a professor of medical ethics and health policyat the Perelman School of Medicine at the University of Pennsylvania."Not just the science that went into the vaccines, but the organizational effort to pull off those trials it's marvelous."

Although Moderna moved extremely fast, winning authorization just 11 months after beginning work on mRNA-1273, ithas been developing the technology behind its vaccinefor a decade.

The company was founded in 2010 on the banks of the Charles River, a short walkfrom the Massachusetts Institute of Technology, where one of its founders was a faculty member,and another a graduate and board member.

That MIT gradand board of trustees member, venture capitalist Noubar Afeyan,said he was intrigued at the time by the idea of making drugs inside the human body.

Messenger RNA, which the body uses to translate the DNA code into the proteins that do all the body's work, seemed like the right tool to address a whole host of medical problems, he said.

Operation Warp Speed has helped Moderna move faster in vaccine development.(Photo: JOSEPH PREZIOSO/AFP via Getty Images)

Afeyan saidhe likes to start companies with big ideas that seem like science fictionand then "take the fiction out" by finding the science to make it real.

Moderna was initially namedLS18 to indicate it was the 18th life sciences company Afeyan had started. (He's lost track of whether his latest company is LS79 or LS80, he said.) The idea was seeded by a stem cell scientist at nearby Harvard University, Derrick Rossi, who was trying to commercialize his research using the body's most versatile cells to make medicines.

Afeyan said it was a provocative concept. But by May of the following year, when the company was officially launched as Moderna, they had dropped the idea of using stem cells, which Afeyan said were too unstable in the body, and focused instead on messenger RNA (hence the name ModeRNA).

Messenger or mRNA is the body's own delivery system, taking "messages" from the DNA code in the cell's nucleus to a protein manufacturing center.

Where's the COVID-19 vaccine? Who's been vaccinated?Here's how we'll know.

These proteins direct every activity of life, so figuringout how to make them on demand could help people who suffer severe diseases because their bodies make faulty proteinsas with sickle cell disease, cystic fibrosis and myriad rare diseases. Such proteins could alsoprime the immune system to target cancer cells, or infectious diseases.

Afeyan and his collaborators wanted to tackle this whole range of medical challenges.

But first, they needed a CEO to run the company.

Afeyan said he had been negotiating with a French entrepreneur who was, like him, a biomedical engineer. ButStphane Bancel wasn't sure he wanted to leave a stable job as CEO of an established diagnostics company for the risk of a startup with a never-before-tried idea.

Bancel was walking home across the Longfellow Bridge from Cambridge to Boston one winter night, when Afeyan called and turned on the hard sell.

Afeyan said he would never have a bigger idea to offer Bancel. If this becomes the next Genentech, "you're going to hate yourself" for not being involved, Afeyan told him, referring to the South San Francisco company that launched the entire biotechnology industry with its birth in 1976.

Later that year, Bancel signed on to run Modernaand continues to lead the company, which has now made several founders and its CEO into billionaires.

Moderna IPO(Photo: Flagship Pioneering)

The earliest seeds of Moderna

There werea few key scientific advances that led mRNA to where it is today.

Onecame from another Moderna co-founder, Robert Langer, a professor at MIT and a serial entrepreneur.

Early in his career, Langer, who had recently earned his doctorate in chemical engineering from MIT, was struggling to find a job. He didn't want to work in the oil industry, though he'd gotten 20 job offers, including fourfrom Exxon alone.

After months of searching, Dr. Judah Folkman, a passionate doctor at what is now called Boston Children's Hospital finally took a chance on him. Folkman believed he could cure cancer by cutting off the blood supply to tumorsbut he couldn't figure out how to slowly release drugs to work effectively.

Nevermind the political messenger: When it comes to COVID-19 guidance, trust the message, experts say

Langer spent years developinga way to encapsulatenucleic acids the same building blocks as in mRNA vaccines into tiny particles that could make their way into cells.

"At first people didn't think it was possible," Langer said. He published a 1976 paper showing it could be donebut still, it was a slog to get people to believe in its potential.

"After that paper came out, I must have had 10 years of people rejecting grants" to support the work, he said. (His work with Folkman provided the underlying science for the drug Avastin, which earned $7 billion in sales in 2019 and is used to treat many types of cancer as well as wet age-related macular degeneration, the leading cause of blindness in older adults.)

Langer and others made additional improvements over the years, includingadding polyethylene glycol to the surface of particles, which enabled them to survive in the body for longer. That's one of the key ingredients of Moderna and Pfizer-BioNTech's vaccines.

A subject receives a shot in the first-stage safety trial of a potential vaccine by Moderna for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16.(Photo: Ted S. Warren, AP)

In 2010, when Langer was one of the world's best knownbioengineers and a leader in the field of drug delivery, Rossi came to see him with a scientific insight he hoped would be the basis for starting a company. Langer introduced him to Afeyan, and the idea for LS18was born.

By the following year,Rossi moved on and the core group includedLanger, Afeyan, Dr. Kenneth Chien, a prominent cardiologist and researcher, andTimothy Springer, an immunologist at Harvard Medical School.

The four met once a week tobrainstorm, while a handful of scientists at Afeyan's Flagship Pioneering advanced their ideas in the lab.

Moderna's first real home wasan underwhelming office half basement, half ground floor just a few blocks away.

The vision from its earliest days, Langer said, was to build a "platform" that could be used as the basis for drugs, vaccinesand even tissue engineering another field he had helped pioneer.

Some Americans aren't in a rush to get a COVID-19 vaccine: Experts understand, but say there's no need to wait.

For several years, Moderna has been collaboratingon vaccine development withscientists at the National Institute of Allergy and Infectious Diseases, the agency led by Dr. Anthony Fauci.

By the end of 2018 when Moderna went public,it was the biggest initial public offering ever for a biotech company, though shares fell 19% that first day as investors worried it was overpriced.

A year later the company was testing 20 different mRNA's in humans five or six times more research programs than the typical biotech.

That was enough, said Nina Deka, a senior research analyst at ROBO Global, for her fund to decide to make Moderna one of the 85 companies included in its portfolio of health care technology and innovation stocks.

Moderna had recently announced plans to develop a COVID-19 vaccine when ROBO Global decided to invest.

"Not because of what they did this year, but what they've done since the start of the company," Deka said.

With two mRNA vaccines under development, ROBO Global expected that even if Moderna's vaccine didn't succeed, the technology would advance, buoying everyone in the industry.

"It's not just vaccines. It's also cancer. It's also orphan drugs" for rare diseases, she said.

The company had just built a brand new production facility in the Boston suburb of Norwood, and it was using advanced artificial intelligence to direct its research, which ROBO Global appreciated,Deka said.

Plus, it was breaking speed records with its candidate COVID-19 vaccine.

"The next question is," Deka said,"if they can do this quickly, what else can they do?"

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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US gets more help in raging battle against COVID-19 as FDA authorizes Moderna vaccine, the second allowed for emergency use - USA TODAY

Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes -…

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to significantly improve the scientific community's insight into type 1 diabetes (T1D) through Diamyd Medical's contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Measures Initiative (TOMI) T1D integrated database.

The Phase III trial evaluated the use of the diabetes vaccine Diamyd, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. It is funded by the world's leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations' strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these robust data sets from industry led trials is critical to TOMI-T1D's work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.

"Progress towards the establishment of approved therapies for people with T1D is critically reliant on participation from our partners in industry with their data", said Simi Ahmed and Elizabeth Robertson, on behalf of the charity partnership.

"This is indeed a right step in that direction", said Colin Dayan, lead PI at Cardiff University.

"We are thrilled that Diamyd Medical is taking a leading role and championing precompetitive collaborations advancing type 1 diabetes regulatory science solutions", said Inish O'Doherty Executive Director at C-Path. "Their data will help in the construction and evaluation of a clinical trial simulation tool to assist in the development of novel therapies for type 1 diabetes patients".

"We are very honored to be part of this important collaboration -involving key stakeholders within the type 1 diabetes landscape, said Ulf Hannelius, President & CEO of Diamyd Medical. "As we are moving into an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high quality data will be integral to maximizing these efforts".

To learn more about the TOMI-T1D project visit: https://c-path.org/programs/tomi-t1d/

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent, and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact and uniting on a national stage to pool resources, passion and energy. We collaborate with academic institutions, policymakers and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

About Diabetes UK

1. Diabetes UK's aim is creating a world where diabetes can do no harm. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health condition in the UK - more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support people living with diabetes can lead a long, full and healthy life. For more information about diabetes and the charity's work, visit http://www.diabetes.org.uk

2. Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not managed well, both type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in people of working age in the UK and is a major cause of lower limb amputation, kidney failure and stroke.

3. People with type 1 diabetes cannot produce insulin. About 10 per cent of people with diabetes have type 1. No one knows exactly what causes it, but it's not to do with being overweight and it isn't currently preventable. It's the most common type of diabetes in children and young adults, starting suddenly and getting worse quickly. Type 1 diabetes is treated by daily insulin doses - taken either by injections or via an insulin pump. It is also recommended to follow a healthy diet and take regular physical activity.

4. People with type 2 diabetes don't produce enough insulin or the insulin they produce doesn't work properly (known as insulin resistance). Around 90 per cent of people with diabetes have type 2. They might get type 2 diabetes because of their family history, age and ethnic background puts them at increased risk. They are also more likely to get type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can be years before they realise they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. In addition, tablets and/or insulin can be required.

For more information on reporting on diabetes, download our journalists' guide: Diabetes in the News: A Guide for Journalists on Reporting on Diabetes (PDF, 3MB).

About Diamyd Medical

Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale metastudy as well as in the Company's European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd. Diamyd Medical also develops the GABA-based investigational drug Remygen as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO

Phone: +46 736 35 42 41

E-mail: ulf.hannelius@diamyd.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392

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SOURCE Diamyd Medical AB

Company Codes: Frankfurt:DMN, ISIN:SE0005162880, Munich:DMN, Stockholm:DMYD, Stockholm:DMYD-B.ST

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