Category Archives: Genetic Engineering

BEIJING, Sept. 8, 2022 /PRNewswire/ -- YishengBio Co., Ltd., ("YishengBio"), a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics, announced that the Company received the approvals from the regulatory authorities of United Arab Emirates (UAE) and the Philippines to conduct Phase 2/3 clinical trials for its PIKA recombinant COVID-19 vaccine. The phase 2/3 clinical trials will evaluate the immunogenicity, efficacy and safety of PIKA COVID-19 vaccine as a booster injection among subjects who received 2 or more doses of inactivated COVID-19 vaccine. The trials are designed to be multi-country, multi-center studies with the enrollment of 9,300 participants in UAE, Philippines and Pakistan.

PIKA recombinant COVID-19 vaccine is a highly differentiated vaccine candidate with potential prophylactic and therapeutic benefits against COVID-19 infection. PIKA recombinant COVID-19 vaccine is composed of PIKA adjuvant and S protein antigen by using genetic engineering technology with appropriate stabilizer. The pre-clinical studies demonstrated that this vaccine candidate is capable of sustaining two year long of high levels of neutralizing antibodies against a wide range of the variants of the COVID-19 virus, including Omicron BA.2, BA.4/5.

Based on the Phase 1 interim results of PIKA COVID-19 vaccine in UAE, the participants who received the low dose of 5 ug per injection were able to achieve high levels of neutralizing antibodies against all currently prevalent SARS-CoV-2 variants, including Omicron BA.2, BA.4/5, both in the prime vaccination regimen and booster dose for subjects who completed 2 doses of inactivated vaccines. PIKA COVID-19 vaccine candidate demonstrated good safety profile in phase 1 study.

"The initiation of the phase 2/3 clinical trials in multi countries will accelerate the clinical development of PIKA recombinant COVID-19 vaccine candidate to a new level," said Mr Yi Zhang, the Chairman and the Project Leader at YishengBio. "PIKA recombinant COVID-19 vaccine candidate achieved high levels of immunogenicity and broad neutralizing antibodies in clinical trials against wide range of SARS-CoV-2 virus strains, including the most prevalent Omicron variant. This vaccine candidate has the potential to become a universal vaccine against the swiftly mutating SARS-CoV-2 virus worldwide. Equally important, our newly constructed manufacturing plant dedicated to the commercialization of PIKA recombinant COVID-19 vaccine was recently granted the drug manufacturing certificate by the China's National Medical Products Administration (NMPA). We are excited about the initiation of this clinical study and eager to bring this valuable and highly differentiated vaccine to the public health arena to help address critical unmet medical needs."

About PIKA Technology:

PIKA technology is an immuno-modulating technology platform based on synthetic biologic complex which is originated from Yishengbio's proprietary research and GMP manufacturing engineering process. Through TLR3, RIG-I and MDA-5 signaling pathways, PIKA molecule can induce prompt production of interferon, cytokines, chemokines and co-stimulatory factors. PIKA administration facilitates antigen cross-presentation by dendritic cells and augments CD4+ T-cell, CD8+ T-cell and natural killer-cell responses. When delivered with relevant antigen-based molecules, PIKA technology can be applied to the development of a new generation of antiviral vaccines, antiviral and anticancer therapeutics, offering a promising platform for the development of a wide variety of novel biologics to improve treatments that are currently available and address unmet medical needs.

About YishengBio:

YishengBio is a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generation of vaccines and therapeutic biologics for infectious diseases and cancer. YishengBio is expanding its business horizon with a global footprint across various countries, including China, United States, Singapore, the Philippines, Pakistan, the UAE and other countries. The Company has developed proprietary PIKA immunomodulating technology platform which augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. PIKA technology platform has empowered and nurtured a diverse and innovative pipeline of vaccines and therapeutic biologics with differentiated efficacy and safety profile to address the unmet medical needs in infectious disease and oncology.

YishengBio is one of the leading suppliers of human rabies vaccine in Chinese market and its development pipeline includes PIKA Rabies Vaccine, PIKA recombinant COVID-19 Vaccine, YS-HBV-001, YS-HBV-002 and YS-ON-001 targeting various prophylactic and therapeutic indications. YishengBio is headquartered in Beijing and has over 800 employees in China, U.S.A, Singapore and other countries in Asia. For more information on YishengBio, please visit http://www.yishengbio.com.

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YishengBio Received Approvals From Philippines and UAE For Phase 2 / 3 Clinical Trials of PIKA Recombinant COVID-19 vaccine - PR Newswire APAC - PR...

DUBLIN--(BUSINESS WIRE)--The "Global Recombinant Cell Culture Supplements Market: Focus on Pricing Analysis, Product, Application, Expression System, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

The global recombinant cell culture supplements market was estimated at $308.6 million in 2021 and is expected to reach $1,188.6 million by 2032, growing at a CAGR value of 12.24% during the forecast period 2022-2032. The growth in the global recombinant cell culture supplements market is expected to be driven by the rising demand for cell culture supplements, increasing investment in life sciences research and development, as well as growing advantages of recombinant supplements over traditional animal-derived supplements.

Market Lifecycle Stage

The global recombinant cell culture market is increasing at a rapid pace. The growing need for animal-free supplements in cell culture applications is aiding the growth of the recombinant cell culture supplements market. Recombinant cell culture supplements play a crucial role in enhancing cell viability, maintaining a healthy culture, and customizing the cell culture in accordance with the needs of the individual.

Increasing demand for immunotherapy and stem cell and regenerative medicine research is one of the major opportunities in the recombinant cell culture supplements market. Several cell culture companies, and biopharmaceutical companies are working collaboratively on drug development and using recombinant cell culture supplements as a therapeutic means for applications in biological drugs. Furthermore, the market witnessed major mergers and acquisitions in the past four years. For instance, recently, in March 2022, Thermo Fisher Scientific Inc. acquired PeproTech, Inc., a company that specializes in the development and manufacturing of recombinant proteins, in a deal of $1.85 billion.

Impact

Many biopharmaceutical products are being developed by utilizing the cell culture technique. The study of cell physiology and biochemistry is made possible through laboratory cell culture, which also opens up research avenues that are challenging to pursue in vivo. Controlling variables such as the culture media, culture conditions, population density, and growth rate makes it simple to assess the effects of medications or other substances on cultured cells.

Additionally, it allows analyzing the function of various genes and offers enormous potential in the field of genetics. It enables the assessment of harmful and carcinogenic chemicals on cells in the fields of oncology and virology and the comprehension of how different medications, viruses, and physical or chemical carcinogens interact.

Furthermore, the recombinant cell culture has various applications, such as research on vaccines, stem cells, gene therapy, and genetic engineering, as well as the creation of protein therapies manufacturing of genetically edited proteins such as monoclonal antibodies, insulin, and hormones.

Market Dynamics

Market Drivers

Market Restraints

Market Opportunities

Market Segmentation

by Product

by Application

by Expression System

by Region

Demand - Drivers and Limitations

Following are the demand drivers for the global recombinant cell culture supplements market:

The market is expected to face some limitations too due to the following challenges:

Key Topics Covered:

1 Market Overview

2 Product, $ Mn, 2021-2032

3 Application, $Mn, 2021-2032

4 Expression System, $Mn, 2021-2032

5 Region, $Mn, 2021-2032

6 Competitive Landscape

7 Company Profiles

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/i5b3yo

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Global Recombinant Cell Culture Supplements Market Report 2022: Increasing Demand for Recombinant Cell Culture Supplements Due to their Advantages...

Madrid.- Immunologist Carl Jun has started a revolution in medicine. He speaks of the resurrection himself like Lazarus, the man who died and was miraculously resurrected by Jesus Christ in the biblical account. June, born 69 years ago in Denver (United States), is the father of CAR-T treatment, a powerful strategy that includes Drawing blood from cancer patients, capturing their white blood cells, and re-engineering them in the laboratory to multiply their ability to kill cancer cells., Complete remission of blood tumorsleukaemia, lymphoma, and myelomaalready number in the hundreds.

The researcher remembers his first case, Bill Ludwig, a 65-year-old prison guard who died of leukemia in August 2010. He was a Catholic and he supported him immensely, recalls June, director of the Center for Cellular Immunotherapy at the University of Pennsylvania. The patient had a tumor of about three kilograms, but 20 days after a single injection of CAR-T cells, no sign of cancer was found. The challenge now is to reduce the exorbitant price of the treatment pharmaceutical companies charge more than 300,000 euros for each patient and make it work even in solid tumors such as the pancreas and brain.As June explains, passing through Madrid to deliver a speech at the Ramon Ares Foundation.

You use the word cure.

At 10 years old, yes. Our first two patients have already been free of leukemia for 10 years, so we can talk about a cure. They were cases like Lazaro. They thought they were about to die and both had the same reaction. When Bill Ludwig was told he no longer had leukemia, he bought a motorhome and traveled around the country with his wife, enjoying a vacation he had never had. The second patient, Doug Olson, is a scientist. When they told her that she no longer had leukemia, she bought a sailboat. Both of them thought that they were going to die and started a new life.

Compare these cases with Lazarus, the man who died and was resurrected by Jesus Christ in the Bible.

They thought they were going to die. Bill Ludwig had already paid for his funeral. Between 1997 and 2000, during the AIDS epidemic, I have seen something similar in medicine. Since there was no medicine, people who had AIDS died. Until effective drugs arrived. I saw it with AIDS and now I see it with these cancer patients who thought they were already dead and suddenly, rapidly, they were cured.

I think in 10 years the cost of CAR-T treatments will be a tenth of what they cost now

Do you know how many lives the CAR-T treatments have saved?

We know that more than 10,000 people in the world have received therapy. And many others are being treated with the experimental protocol. There are currently about a thousand clinical trials going on with CAR-T cells in the world.

-You were the promoter of the first authorized CAR-T therapy called kimariyah, In Spain, pharmaceutical company Novartis has fixed the price of Kymaria at 320,000 euros per patient. Do you think its a fair price? [Carl June reconoce un conflicto de intereses, ya que posee la propiedad intelectual de patentes licenciadas a Novartis]

-When we talk about fair price, it varies depending on the country. Its kind of awful, but Americas insurance companies are willing to pay $130,000 a year [cifra similar al cambio en euros] For anything that inspires you to live another year in health. The value of a person can be reduced to euros or dollars. And in the United States and Europe it is about $100,000 a year. They have observed that CAR-T cells offer a very long survival time. And theyve also studied the treatments that are used today: Other myeloma treatments, not CAR-Ts, cost a million dollars per patient and, on top of that, most die. In fact, CAR-T treatment is cheaper than it is now, even though they charge 300,000 euros. having said that, Its still expensive. The cost has to be reduced.

-How?

The most expensive part of CAR-T is the human work: Highly specialized scientists produce cells on a case-by-case basis, If robots could do this, it would be very cheap. This has already happened with many other new technologies, which eventually became cheaper to manufacture on a large scale. Computers were also very expensive earlier. What will happen to the CAR-T cell in 10 years? I am sure that instead of creating people in a procedure that requires two weeks, the hospital itself will have a machine in which the patients blood will be drawn and the CAR-T cells will come out on their own. I think in 10 years they will have to spend a tenth of their cost.

A Spanish public hospital, the Clinique de Barcelona, has developed its own CAR-T treatment against acute lymphoblastic leukemia and multiple myeloma. The price of these public CAR-Ts is 90,000 per patient, Novartis and other big pharma seem to be making a huge profit margin.

Well, the data so far shows that none of these big companies are making money from these cell therapies. Novartis makes a lot of profit out of the rest of the drugs it sells. The cost of producing a standard drug may be 5% of the direct selling price. In the case of CAR-T it is much higher. For example, they make much less money selling CAR-T cells than selling aspirin. Manuel Juan [jefe de Inmunologa del Hospital Clnic] He spent about three months with us learning how to make CAR-T cells and he is a great person. This has achieved a very efficient process, but has cost the pharmaceutical industry a lot. Different companies have to improve and make it cheaper, because thats how innovation and competition work. Unfortunately, it will probably take 10 years to fix this problem.

The most expensive part of CAR-T is human work: Very specialized scientists produce cells on a case-by-case basis. If it can be done by robots, it will be much cheaper.

-Novartis CEO, vas narasimhaniwon last year about 12 million euros, Does this salary make sense given the exorbitant cost of CAR-T treatments?

-Novartis has over 100,000 employees. These big pharmaceutical companies spend a lot of money on research and some of their drugs are life changing. You want to do research to develop new products, but you also dont want to make obscene profits. The average cost of new cancer drugs is more than $100,000 per year. CAR-T cells are the most expensive cancer treatment, but cell therapy for the treatment of sickle cell anemia and thalassemia has just been approved. I think they charge $2.3 million. It is a treatment for a fatal disease, but it is expensive as it requires a bone marrow transplant. And its far more difficult to do genetic engineering with stem cells [precursoras de las clulas de la sangre en la mdula sea], It is the most expensive treatment in the United States right now. Sickle cell anemia kills you. It is the most common fatal genetic disease and occurs mainly in black people who do not have health insurance. So now we have a way to treat it, but of course nobody has $2.3 million.

Drugs dont work if people cant afford them.

-accurate. Technology is making it possible to do things that have never been done before, such as cell engineering. Its expensive, but it works. The question is how to make it fair. Ive been to Costa Rica three times and were going to start a trial to see if we can develop this technology in a middle-income country. Right now there are no trials with CAR-T cells in Central or South America, only in Europe, the United States, China and Japan.

A decade ago, you said in an interview That all research on CAR-T treatment was being done in universities. Now it is the companies that take advantage.

Yes, this is a common problem in the United States and Europe. Citizens pay with their taxes to educational centers for the development of these treatments, and then they pay again to receive therapy.

Citizens pay twice for the same medicine.

Yes, this is a problem that should be solved with policies. Science is top notch. Research is now taking place in both industry and academia. Ten years ago research was academic only. Pharmaceutical companies now make more money than the US National Cancer Institute, which doesnt mean they do the most innovative research.

There are about 300 types of cancer and each one has pain in the heel which makes it vulnerable

CAR-T therapies against leukemia, lymphoma and myeloma have been approved in many countries. What about solid tumors, such as tumors of the pancreas, brain, or lung?

-There are experimental trials with all of these, but none of these treatments are authorized. We need more research. Pancreatic cancer and brain cancer are two of the worst and are already progressing. We now have an exciting trial at the University of Pennsylvania, in which we are combining an oncolytic virusa virus modified to infect tumor cellsand CAR-T cells. Were Doing It With Ramon Alemanni [investigador del Instituto Cataln de Oncologa], which is in Barcelona. So far we have treated only one patient, but it is very exciting. This is for pancreatic cancer and ovarian cancer. I think were going to need these kinds of combinations to deal with solid tumours. It is far more difficult for the immune system to completely eliminate a solid tumor than it is for leukemia. There have been about a thousand trials of CAR-T now, its being tested on any cancer you can think of.

Do you think that in 10 years there will be effective CAR-T cells against solid tumors?

There are about 300 types of cancer and each one causes heel pain which makes it debilitating. unfortunately, We are not going to have a single cure for all cancers. I think what we will have is, for example, something that only works against ovarian cancer, that works against breast cancer, or against leukemia. For leukemia you only need a single infusion of CAR-T cells and thats it. In solid tumors it would be much more complicated. In a laboratory dish, CAR-T cells kill pancreatic cancer, but in people solid tumors have a wall around them that prevents CAR-T cells from penetrating. This blood is not present in the tumor.

Manuel Ansede. By

EL PAS, SL

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Cancer: "I See Patients Who Thought They Were Already Dead And Suddenly, They Are Cured", Says Father Of A Revolutionary Treatment - Nation...

In a ground-breaking move, the Australian Department of Foreign Affairs and the Government of Telangana, India have joined hands for an exchange, considered to be rewarding for women entrepreneurs of both nations.

The business exchange, known as CyberTech Women Entrepreneurs program, is an opportunity for women entrepreneurs to provide access and business pathways for women-led technology businesses in Australia and India.

The accelerator program is part of the Australia-India Bilateral Cyber and Critical Technology Partnership (AICCTP), supported by the Australian Department of Foreign Affairs and Trades Cyber Affairs team.

Deepthi Ravula, chief executive officer of WE Hub, said, For over a decade, start-ups, especially women entrepreneurs in tech, have expressed a lack of opportunities and financial support to optimally scale up their businesses globally.

The program will host six women-led Indian start-ups and six women-led Australian start-ups primarily in the areas of cybersecurity and critical technologies.

The program aims to support the launch of above mentioned shortlisted start-ups in the other nation with further soft-landing support in the respective markets for three months beyond the program.

Entries so far have included women entrepreneurs working in artificial intelligence, blockchain, quantum computing, next-generation telecommunications, the internet of things, synthetic biology, genomics and genetic engineering, low-emission alternative fuels, autonomous vehicles, drones, swarming and collaborative robotics, and big data.

This exchange program will be integral to building an ongoing bilateral start-up-scale-up exchange initiative to support and enrich the start-up ecosystem for female entrepreneurs in cyberspace and critical technology across the two nations, said Irfan Malik, CEO, inQ Innovation Global.

He added that his team has been working with DFAT since March to devise a program that offers an all-inclusive scale-up ecosystem crucial for women-led tech start-ups and thanks the Telangana Government, and ecosystem partners for the chance to curate this outcome-driven program.

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Australia and India join hands to enable female tech talent to take flight - People Matters

What we found

First, we exposed pieces of seahorse pouch to isotocin. While isotocin caused our control tissues (intestine) to contract, surprisingly this hormone produced no contractions in the brood pouch.

The result led us to wonder about the anatomy of the pouch. When we examined the pouch under a microscope, we found it contains only scattered small bundles of smooth muscle, far less than the uterus of female mammals. This explained why the pouch did not contract in our experiments.

Using 3D imaging techniques combined with microscopy, we then compared the body structure of male and female pot-bellied seahorses.

In males, we found three bones positioned near the pouch opening, associated with large skeletal muscles. These types of bones and muscles control the anal fin in other fish species. In seahorses, the anal fin is minuscule and has little or no function in swimming.

So, the large muscles associated with the tiny seahorse fin are surprising. The anal fin muscles and bones are much larger in male seahorses than in female seahorses, and their orientation suggests they could control the opening of the pouch.

Seahorse courtship is an elaborate process. Males open and fill their pouch with water by bending forward and contracting their bodies to force water into the pouch, before dancing with the female.

Similarly, during labor, male seahorses bend their body towards the tail, pressing and then relaxing. This pressing behavior is accompanied by brief gaping of the pouch opening, with a series of whole-body jerks. This movement combined with pouch opening allows seawater to flush through the pouch.

Jerking and pressing continue, the pouch opening gets gradually bigger, and groups of seahorse babies are ejected with each movement. Many hundreds of babies are ejected in a short time.

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How seahorse fathers use their unique body and behavior to give birth - Interesting Engineering

Story by Alexey Slavin. Abridged translation by Sam Breazeale.

After Russia launched its full-scale war against Ukraine, the Czech Education Ministry announced that Russians and Belarusians who study in certain departments at Czech universities would be required to either leave the institutions or change their majors to ones considered safe by the Czech authorities. The agency cited EU sanctions against Russia and laws banning the provision of technical assistance to Russia, including by teaching students certain skills. Meduza looked at how this has affected Russian students and what options are left for Russians who want to study in the Czech Republic.

The European Commission's first measures aimed at lowering the amount of "technological support" supplied by EU member states to Russia came in 2014 in response to Russia's annexation of Crimea. The recommendations were just that; each country had the option to impose restrictions or not. Meanwhile, most of the binding sanctions passed then were against officials, defense companies, and government banks; the education sector was hardly affected at all.

But this year, things have begun to change. Soon after Russias full-scale invasion of Ukraine in February 2022, the Czech Republic imposed a ban on issuing non-humanitarian visas and residency permits to Russian and Belarusian citizens. In April, Czech Education Minister Petr Gazdk announced that the Czech authorities believe Russian students studying in technical fields pose a threat to the countrys security.

In mid-May, the Czech Education Ministry published a list of recommendations for how to deal with students from EU-sanctioned countries. One of the proposals was for Czech universities to impose a limit on the number of students they accepted from Russia and Belarus. Another suggestion was to limit the number of spots for those students in unsafe departments.

Exactly which fields of study qualify as unsafe was determined by the countrys Financial Analytical Office (the agency responsible for ensuring Prague observes international sanctions). A task force was created within the agency to issue recommendations for how each government ministry should respond to sanctions.

According to the European Commission, teaching students skills in these fields falls under the ban on providing technological support to the Russian Federation. The Czech Education Ministry sent universities a guide that suggests transferring Russian and Belarusian students to safer courses of study ones that arent likely to give them access to information that could be used against the Czech Republic in the future.

The ministry gave each university the freedom to decide which subjects to ban for the students and what to replace them with. Some schools, however, categorized almost all of their majors as unsafe. According to Ksenia Lazarov, who works with foreign students at a support center in Prague, students who had passed the entrance exams for the Czech Technical University in Prague with perfect scores started receiving notifications that they had not been accepted, though they weren't told why.

We found this ban extremely strange. The guides expressly say that the restrictions are intended for students in masters and doctorate programs and that theres no need for them to be applied to bachelors programs, which dont contain any secret information that couldnt be found on the Internet or other open sources, she said.

According to Lazarov, the university suggested that students write statements of purpose explaining why it's important for them to stay in the Czech Republic and how they feel about Russias war against Ukraine. Having a document like that would allow [the university] to defend the students to the Education Ministry and the Interior Ministry," she said.

Some institutions offered to let students switch majors. One such school was the Brno University of Technology, which allowed all students who passed the entrance exams regardless of citizenship to enroll. University rector Ladislav Janek explained the decision this way: I understand that its vital to observe EU sanctions against Russia and Belarus. But it would be illogical to automatically transfer [the sanctions] to students who have already chosen the Czech Republic for their studies, and possibly for their future lives as well."

Radana Koudelova, the press secretary for the Brno University of Technology, told Meduza that in the universitys view, allowing Russian and Belarusian students to study critical topics such as cybersecurity, aviation, telecommunications, and microelectronics is tantamount to the intangible transfer of technology at wartime.

Current students with the exception of students in their final year were given the option to transfer to 'non-critical' courses of study. The majority of them took advantage of the opportunity. Students who refused were forced to end their studies [at this school], said Koudelova.

Meduza reached out to the Czech Technical Universitys press service, but had not heard back at the time of this articles publication.

Earlier this year, a Russian citizen named Alexander applied to Czech Technical University and was rejected. The schools transportation department, where he wanted to study, categorically refused to accept students from Russia. Alexander told Meduza that a number of Russian and Belarusian students currently studying at the university signed a document in which they promised not to use the knowledge they gain there outside of the EU. Alexander himself decided to write a letter explaining that he doesnt support the war in Ukraine.

In the rejection letter, [university representatives] listed all of Russias sins, including the annexation of Crimea. I was 15 years old when that happened. I wrote in my letter that I started attending protests in 2017, and that I was even arrested a few times; I had to await my trials in a special detention facility. I also described in detail why I want to study at VUT specifically and told the story of how I prepared to apply. I also mentioned that I worked as a volunteer at a humanitarian aid center for Ukrainian refugees in Prague.

In order to stay in Russia, I applied to the construction department at the Brno University of Technology, which hasnt imposed sanctions against students, said Alexander.

Later, though, his first choice school responded to his letter. On August 23, I received a letter from the Czech Technical University that on the basis of a decision made by the rector, they would allow me to enroll, he said.

Ksenia Lazarov told Meduza that the Czech University of Life Sciences Prague is another university thats cracked down on Russian and Belarusian students. This year, she said, they rejected about 200 applicants from Russia and Belarus.

One of those applicants was Anna Smirnova, a 19-year-old from the town of Ukhta in Russias Komi Republic. Immediately after high school, unable to imagine a future for herself in Russia, she moved to Prague, where she took language classes and prepared to apply to universities. In June, Anna earned 86 points (16 more than necessary) on the entrance exam for the Czech University of Life Sciences Pragues genetic engineering department.

According to Anna, when she took the test, nobody mentioned anything about the university refusing to accept Russian or Belarusian students. The new rule was announced on June 30. Several days after Annas exam results were posted on the universitys site, she learned that she wouldnt be admitted for other reasons.

Anna received her official rejection letter several weeks later (Meduza has obtained a copy of the letter). The universitys administration cited three government decrees: one from 2006, one from 2014, and one from 2022. The documents mention Russias annexation of Crimea, Russias attack on Ukraine, and Belaruss disregard for democratic principles, as well as demanding a restriction on trade relations and an end to technological assistance. One of Annas classmates, a girl from Kazakhstan, however, was accepted with no issues. The Czech University of Life Sciences Prague did not respond to Meduzas request for comment.

Im currently located in the Czech Republic, where Im applying to other universities so that I can stay here. Im still waiting for an answer. We werent told that we wouldnt be admitted [to the Czech University of Life Sciences Prague] until really late, and its already too late to get into a normal university. I applied to the natural science department at UJEP [Jan Evangelista Purkyn University], but I wont hear back until early September at the earliest. Im currently stuck in limbo; I dont know whether Ill be able to stay here or not, said Smirnova.

Stanislav Keek, the Czech Republics human rights ombudsman, has been a strong advocate for Russian and Belarusian students, claiming the new rules contradict existing European legislation: according to a regulation from the European Parliament and the Council of Europe, foreigners have the right to receive residency permits or student visas if the characteristics and purpose of their stay in the EU meet the documents' requirements. The ombudsman has suggested adding students to a list of exceptions for repressed citizens and resuming the issuance of student visas. The Czech Interior Minister, however, has said he believes Prague needs to continue imposing severe restrictions against Russia.

Belarusians and Russians who are trying to apply to Czech universities remotely are perhaps in the most difficult situation of all. Even when Czech universities accept their applicants documents, Czech consulates are not issuing the prospective students visas. The Czech Republic imposed limits of Russians and Belarusians immediately after the start of the war on February 28.

The Education Ministry believes that theres no guarantee that people who enter under these visas wont carry a potential threat to the country. This rhetoric appeared in the Czech Republic at the very start of the war, said Anton Vaykhel, who heads a support center for foreigners in the Czech Republic.

Applicants who passed the entrance exams between April and June and were supposed to be able to come to the Czech Republic by the start of the academic year will now be unable to. They spent time and money on their preparations. So the ones who are located in Russia are suffering most of all, said Vaykhel.

In his opinion, these kinds of restrictions are ineffective and, in some cases, even harmful: young people who have successfully gone through the procedures necessary to enroll in Czech universities but are not allowed to enter the country because of visa restrictions will automatically lose their army deferment.

Were trying to fight this; weve been writing to the [Czech] Interior Ministry and trying to get in touch with ministers and journalists on social media. But so far, the authorities are still saying that their top priority is to help Ukraine and protect their own citizens, said Vaykhel. To be honest, at the moment, it feels like tilting at windmills. Its very difficult to influence the views that have taken root [about Russians in the Czech Republic].

Story by Alexey Slavin.

Abridged translation by Sam Breazeale.

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Potential threats to the country - Meduza

Manipulation of genes in natural organisms, such as plants, animals, and even humans, is considered genetic engineering. This is done using a variety of different techniques like molecular cloning. These processes can cause dramatic changes in the natural makeup and characteristic of the organism. There are benefits and risks associated with genetic engineering, just like most other scientific practices.

Genetic engineering offers benefits such as:

1. Better Flavor, Growth Rate and NutritionCrops like potatoes, soybeans and tomatoes are now sometimes genetically engineered in order to improve size, crop yield, and nutritional values of the plants. These genetically engineered crops also possess the ability to grow in lands that would normally not be suitable for cultivation.

2. Pest-resistant Crops and Extended Shelf LifeEngineered seeds can resist pests and having a better chance at survival in harsh weather. Biotechnology could be in increasing the shelf life of many foods.

3. Genetic Alteration to Supply New FoodsGenetic engineering can also be used in producing completely new substances like proteins or other nutrients in food. This may up the benefits they have for medical uses.

4. Modification of the Human DNAGenes that are responsible for unique and desirable qualities in the human DNA can be exposed and introduced into the genes of another person. This changes the structural elements of a persons DNA. The effects of this are not know.

The following are the issues that genetic engineering can trigger:

1. May Hamper Nutritional ValueGenetic engineering on food also includes the infectivity of genes in root crops. These crops might supersede the natural weeds. These can be dangerous for the natural plants. Unpleasant genetic mutations could result to an increased allergy occurrence of the crop. Some people believe that this science on foods can hamper the nutrients contained by the crops although their appearance and taste were enhanced.

2. May Introduce Risky PathogensHorizontal gene shift could give increase to other pathogens. While it increases the immunity against diseases among the plants, the resistant genes can be transmitted to harmful pathogens.

3. May Result to Genetic ProblemsGene therapy on humans can end to some side effects. While relieving one problem, the treatment may cause the onset of another issue. As a single cell is liable for various characteristics, the cell isolation process will be responsible for one trait will be complicated.

4. Unfavorable to Genetic DiversityGenetic engineering can affect the diversity among the individuals. Cloning might be unfavorable to individualism. Furthermore, such process might not be affordable for poor. Hence, it makes the gene therapy impossible for an average person.

Genetic engineering might work excellently but after all, it is a kind of process that manipulates the natural. This is altering something which has not been created originally by humans. What can you say about this?

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Pros and Cons of Genetic Engineering - HRF

Techniques Other than Genetic EngineeringSimple Selection

The easiest method of plant genetic modification (see Operational Definitions in Chapter 1), used by our nomadic ancestors and continuing today, is simple selection. That is, a genetically heterogeneous population of plants is inspected, and superior individualsplants with the most desired traits, such as improved palatability and yieldare selected for continued propagation. The others are eaten or discarded. The seeds from the superior plants are sown to produce a new generation of plants, all or most of which will carry and express the desired traits. Over a period of several years, these plants or their seeds are saved and replanted, which increases the population of superior plants and shifts the genetic population so that it is dominated by the superior genotype. This very old method of breeding has been enhanced with modern technology.

An example of modern methods of simple selection is marker-assisted selection, which uses molecular analysis to detect plants likely to express desired features, such as disease resistance to one or more specific pathogens in a population. Successfully applying marker-assisted selection allows a faster, more efficient mechanism for identifying candidate individuals that may have superior traits.

Superior traits are those considered beneficial to humans, as well as to domesticated animals that consume a plant-based diet; they are not necessarily beneficial to the plant in an ecological or evolutionary context. Often traits considered beneficial to breeders are detrimental to the plant from the standpoint of environmental fitness. For example, the reduction of unpalatable chemicals in a plant makes it more appealing to human consumers but may also attract more feeding by insects and other pests, making it less likely to survive in an unmanaged environment. As a result, cultivated crop varieties rarely establish populations in the wild when they escape from the farm. Conversely, some traits that enhance a plant's resistance to disease may also be harmful to humans.

Crossing occurs when a plant breeder takes pollen from one plant and brushes it onto the pistil of a sexually compatible plant, producing a hybrid that carries genes from both parents. When the hybrid progeny reaches flowering maturity, it also may be used as a parent.

Plant breeders usually want to combine the useful features of two plants. For example, they might add a disease-resistance gene from one plant to another that is high-yielding but disease-susceptible, while leaving behind any undesirable genetic traits of the disease-resistant plant, such as poor fertility and seed yield, susceptibility to insects or other diseases, or the production of antinutritional metabolites.

Because of the random nature of recombining genes and traits in crossed plants, breeders usually have to make hundreds or thousands of hybrid progeny to create and identify those few that possess useful features with a minimum of undesirable features. For example, the majority of progeny may show the desired disease resistance, but unwanted genetic features of the disease-resistant parent may also be present in some. Crossing is still the mainstay of modern plant breeding, but many other techniques have been added to the breeders' tool kit.

Interspecies crossing can take place through various means. Closely related species, such as cultivated oat (Avena sativa) and its weedy relative wild oat (Avena fatua), may cross-pollinate for exchange of genetic information, although this is not generally the case. Genes from one species also can naturally integrate into the genomes of more distant relatives under certain conditions. Some food plants can carry genes that originate in different species, transferred both by nature and by human intervention. For example, common wheat varieties carry genes from rye. A common potato, Solanum tuberosum, can cross with relatives of other species, such as S. acaule (Kozukue et al., 1999) or S. chacoense (Sanford et al., 1998; Zimnoch-Guzowska et al., 2000).

Chromosome engineering is the term given to nonrecombinant deoxyribonucleic acid (rDNA) cytogenetic manipulations, in which portions of chromosomes from near or distant species are recombined through a natural process called chromosomal translocation. Sears (1956, 1981) pioneered the human exploitation of this process, which proved valuable for transferring traits that were otherwise unattainable, such as pest or disease resistance, into crop species. However, because transferring large segments of chromosomes also transferred a number of neutral or detrimental genes, the utility of this technique was limited.

Recent refinements allow plant breeders to restrict the transferred genetic material, focusing more on the gene of interest (Lukaszewski, 2004). As a result, chromosome engineering is becoming more competitive with rDNA technology in its ability to transfer relatively small pieces of DNA. Several crop species, such as corn, soybean, rice, barley, and potato, have been improved using chromosome engineering (Gupta and Tsuchiya, 1991).

Sometimes human technical intervention is required to complete an interspecies gene transfer. Some plants will cross-pollinate and the resulting fertilized hybrid embryo develops but is unable to mature and sprout. Modern plant breeders work around this problem by pollinating naturally and then removing the plant embryo before it stops growing, placing it in a tissue-culture environment where it can complete its development. Such embryo rescue is not considered genetic engineering, and it is not commonly used to derive new varieties directly, but it is used instead as an intermediary step in transferring genes from distant, sexually incompatible relatives through intermediate, partially compatible relatives of both the donor and recipient species.

Recent advances in tissue-culture technologies have provided new opportunities for recombining genes from different plant sources. In somatic hybridization, a process also known as cell fusion, cells growing in a culture medium are stripped of their protective walls, usually using pectinase, cellulase, and hemicellulase enzymes. These stripped cells, called protoplasts, are pooled from different sources and, through the use of varied techniques such as electrical shock, are fused with one another.

When two protoplasts fuse, the resulting somatic hybrid contains the genetic material from both plant sources. This method overcomes physical barriers to pollen-based hybridization, but not basic chromosomal incompatibilities. If the somatic hybrid is compatible and healthy, it may grow a new cell wall, begin mitotic divisions, and ultimately grow into a hybrid plant that carries genetic features of both parents. While protoplast fusions are easily accomplished, as almost all plants (and animals) have cells suitable for this process, relatively few are capable of regenerating a whole organism, and fewer still are capable of sexual reproduction. This non-genetic engineering technique is not common in plant breeding as the resulting range of successful, fertile hybrids has not extended much beyond what is possible using other conventional technologies.

Somaclonal variation is the name given to spontaneous mutations that occur when plant cells are grown in vitro. For many years plants regenerated from tis-sue culture sometimes had novel features. It was not until the 1980s that two Australian scientists thought this phenomenon might provide a new source of genetic variability, and that some of the variant plants might carry attributes of value to plant breeders (Larkin and Scowcroft, 1981).

Through the 1980s plant breeders around the world grew plants in vitro and scored regenerants for potentially valuable variants in a range of different crops. New varieties of several crops, such as flax, were developed and commercially released (Rowland et al., 2002). Molecular analyses of these new varieties were not required by regulators at that time, nor were they conducted by developers to ascertain the nature of the underlying genetic changes driving the variant features. Somaclonal variation is still used by some breeders, particularly in developing countries, but this non-genetic engineering technique has largely been supplanted by more predictable genetic engineering technologies.

Mutation breeding involves exposing plants or seeds to mutagenic agents (e.g., ionizing radiation) or chemical mutagens (e.g., ethyl methanesulfonate) to induce random changes in the DNA sequence. The breeder can adjust the dose of the mutagen so that it is enough to result in some mutations, but not enough to be lethal. Typically a large number of plants or seeds are mutagenized, grown to reproductive maturity, and progeny are derived. The progeny are assessed for phenotypic expression of potentially valuable new traits.

As with somaclonal variation, the vast majority of mutations resulting from this technique are deleterious, and only chance determines if any genetic changes useful to humans will appear. Other than through varying the dosage, there is no means to control the effects of the mutagen or to target particular genes or traits. The mutagenic effects appear to be random throughout the genome and, even if a useful mutation occurs in a particular plant, deleterious mutations also will likely occur. Once a useful mutation is identified, breeders work to reduce the deleterious mutations or other undesirable features of the mutated plant. Nevertheless, crops derived from mutation breeding still are likely to carry DNA alterations beyond the specific mutation that provided the superior trait.

Induced-mutation crops in most countries (including the United States) are not regulated for food or environmental safety, and breeders generally do not conduct molecular genetic analyses on such crops to characterize the mutations or determine their extent. Consequently, it is almost certain that mutations other than those resulting in identified useful traits also occur and may not be obvious, remaining uncharacterized with unknown effects.

Worldwide, more than 2,300 different crop varieties have been developed using induced mutagenesis (FAO/IAEA, 2001), and about half of these have been developed during the past 15 years. In the United States, crop varieties ranging from wheat to grapefruit have been mutated since the technique was first used in the 1920s. There are no records of the molecular characterizations of these mutant crops and, in most cases, no records to retrace their subsequent use.

Several commercial crop varieties have been developed using cell selection, including varieties of soybeans (Sebastian and Chaleff, 1987), canola (Swanson et al., 1988), and flax (Rowland et al., 1989). This process involves isolating a population of cells from a so-called elite plant with superior agricultural characteristics. The cells are then excised and grown in culture. Initially the population is genetically homogeneous, but changes can occur spontaneously (as in somaclonal variation) or be induced using mutagenic agents. Cells with a desired phenotypic variation may be selected and regenerated into a whole plant. For example, adding a suitable amount of the appropriate herbicide to the culture medium may identify cells expressing a novel variant phenotype of herbicide resistance. In theory, all of the normal, susceptible cells will succumb to the herbicide, but a newly resistant cell will survive and perhaps even continue to grow. An herbicide-resistant cell and its derived progeny cell line thus can be selected and regenerated into a whole plant, which is then tested to ensure that the phenotypic trait is stable and results from a heritable genetic alteration. In practice, many factors influence the success of the selection procedure, and the desired trait must have a biochemical basis that lends itself to selection in vitro and at a cellular level.

Breeders cannot select for increased yield in cell cultures because the cellular mechanism for this trait is not known. The advantage of cell selection over conventional breeding is the ability to inexpensively screen large numbers of cells in a petri dish in a short time instead of breeding a similar number of plants in an expensive, large field trial conducted over an entire growing season.

Like somaclonal variation, cell selection has largely been superceded by recombinant technologies because of their greater precision, higher rates of success, and fewer undocumented mutations.

As noted in Chapter 1, this report defines genetic engineering specifically as one type of genetic modification that involves an intended targeted change in a plant or animal gene sequence to effect a specific result through the use of rDNA technology. A variety of genetic engineering techniques are described in the following text.

Agrobacterium tumefaciens is a naturally occurring soil microbe best known for causing crown gall disease on susceptible plant species. It is an unusual pathogen because when it infects a host, it transfers a portion of its own DNA into the plant cell. The transferred DNA is stably integrated into the plant DNA, and the plant then reads and expresses the transferred genes as if they were its own. The transferred genes direct the production of several substances that mediate the development of a crown gall.

Among these substances is one or more unusual nonprotein amino acids, called opines. Opines are translocated throughout the plant, so food developed from crown gall-infected plants will carry these opines. In the early 1980s strains of Agrobacterium were developed that lacked the disease-causing genes but maintained the ability to attach to susceptible plant cells and transfer DNA.

By substituting the DNA of interest for the crown gall disease-causing DNA, scientists derived new strains of Agrobacterium that deliver and stably integrate specific new genetic material into the cells of target plant species. If the transformed cell then is regenerated into a whole fertile plant, all cells in the progeny also carry and may express the inserted genes. Agrobacterium is a naturally occurring genetic engineering agent and is responsible for the majority of GE plants in commercial production.

Klein and colleagues (1987) discovered that naked DNA could be delivered to plant cells by shooting them with microscopic pellets to which DNA had been adhered. This is a crude but effective physical method of DNA delivery, especially in species such as corn, rice, and other cereal grains, which Agrobacterium does not naturally transform. Many GE plants in commercial production were initially transformed using microprojectile delivery.

In electroporation, plant protoplasts take up macromolecules from their surrounding fluid, facilitated by an electrical impulse. Cells growing in a culture medium are stripped of their protective walls, resulting in protoplasts. Supplying known DNA to the protoplast culture medium and then applying the electrical pulse temporarily destabilizes the cell membrane, allowing the DNA to enter the cell. Transformed cells can then regenerate their cell walls and grow to whole, fertile transgenic plants. Electroporation is limited by the poor efficiency of most plant species to regenerate from protoplasts.

DNA can be injected directly into anchored cells. Some proportion of these cells will survive and integrate the injected DNA. However, the process is labor intensive and inefficient compared with other methods.

The genes of most plant and some animal (e.g., insects and fish) species carry transposons, which are short, naturally occurring pieces of DNA with the ability to move from one location to another in the genome. Barbara McClintock first described such transposable elements in corn plants during the 1950s (Cold Spring Harbor Laboratory, 1951). Transposons have been investigated extensively in research laboratories, especially to study mutagenesis and the mechanics of DNA recombination. However, they have not yet been harnessed to deliver novel genetic information to improve commercial crops.

Genetic features can be added to plants and animals without inserting them into the recipient organism's native genome. DNA of interest may be delivered to a plant cell, expressing a new proteinand thereby a new traitwithout becoming integrated into the host-cell DNA. For example, virus strains may be modified to carry genetic material into a plant cell, replicate, and thrive without integrating into the host genome. Without integration, however, new genetic material may be lost during meiosis, so that seed progeny may not carry or express the new trait.

Many food plants are perennials or are propagated by vegetative means, such as grafting or from cuttings. In these cases the virus and new genes would be maintained in subsequent, nonsexually generated populations. Technically such plants are not products of rDNA because there is no recombination or insertion of introduced DNA into the host genome. Although these plants are not GE, they do carry new DNA and new traits. No such products are known to be currently on the market in the United States or elsewhere. (See McHughen [2000] for further information on genetic mechanisms used in plant improvement.)

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Methods and Mechanisms for Genetic Manipulation of Plants, Animals, and ...

Introduction

The ability to edit eukaryotic DNA entails an almost limitless ability to alter the genetic makeup of the plants that become our food. Recently, scientific attention has been directed to applying a class of new gene-editing techniques that utilize CRISPR to food crops for the introduction of commercially desirable traits. Gene-edited crops can have a positive impact on food productivity, quality, and environmental sustainability, and CRISPR is unique in its relative simplicity, robust flexibility, cost-effectiveness, and wide scope of use. The increased use of CRISPR in agriculture has endless applications, the consequences of which are only recently being analyzed.

CRISPR & the Power of Gene Editing

The term CRISPR refers generally to a class of gene-editing mechanisms derived from prokaryotic immune systems. These mechanisms feature two main components: guiding RNA molecules that direct the second component, CRISPR-associated ("Cas") proteins, to the target region of cellular DNA. These Cas proteins induce a double-stranded break in the DNA and allow for targeted manipulation of the desired genetic code. There is incredible diversity in the CRISPR-Cas system and a multitude of different Cas proteins that can be fine-tuned to induce desired changes with high specificityincluding the activation or deactivation of individual genes, or the insertion of genes from other organisms into the target genome.

CRISPR's flexibility stands in sharp contrast to the previous generation of gene-editing technologies, such as Zinc Finger Nucleases and Transcription Activator-Like Effector Nucleases ("TALENs"), which require massive amounts of preemptive research and development and have a far more limited scope of use. This simultaneous precision and flexibility therefore provides ample opportunity for gene-edited optimization of food crops and has already been used in some instances to create, for example, browning-resistant mushrooms. In late 2021, in Japan, the first CRISPR-edited food product was introduced to the global market: tomatoes with high levels of GABA, a naturally occurring neurotransmitter, due to a CRISPR-inactivated gene.

The power of CRISPR has incredible potential for innovation, but the rights and regulations associated with CRISPR have been elusive and, at times, contentious. CRISPR's game-changing technology was the subject of a series of patent priority, inventorship, and, hence, ownership disputes between high-profile research institutionsthe recent results of which have significant implications for global food supplies.

Patent Landscape

Like most cutting-edge technologies, the invention of CRISPR was accompanied by a flurry of patent application filings in the United States and elsewhere, as researchers who brought CRISPR to light sought to protect and monetize their rights as inventors. Numerous academic institutionsincluding Harvard's and MIT's Broad Institute, the University of California, University of Vienna, Vilnius University, The Rockefeller University, and companies such as ToolGen, Inc., Sigma-Aldrich (Millipore Sigma), Caribou Biosciences, Inc., Editas Medicine, Inc., Keygene N.V., Depixus, Blueallele Corp., and CRISPR Therapeutics AG, among numerous other institutions and companieshave secured U.S. and foreign patent rights related to the applications of CRISPR technology. As CRISPR continues to expand in use, especially in the case of CRISPR-edited agriculture that evade many regulations other GMO foods cannot, the complexity of the patent landscape will almost certainly continue to grow.

EU Regulatory Landscape

In general, the EU subjects agricultural products edited with CRISPR technology to the full suite of genetically modified organism ("GMO") premarket approval, safety, and labeling requirements. The primary EU regulation on point, Directive 2001/18/EC (the "GMO Directive"), was promulgated in 2001 by the European Parliament and Council of the European Union. The GMO Directive requires all EU Member States to create appropriate precautionary measures regarding the release of GMOs in the market. However, the definition of GMO in the GMO Directive apparently excludes CRISPR modification, stating that a GMO is as "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."

It was not until 2018 that the EU addressed this gap in the GMO Directive. In July 2018, the Court of Justice of the European Union explained in Case C-528/16 that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive. "Only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive."

The following year, in November 2019, the Council of the EU formally requested that the European Commission "submit a study in light of the Court of Justice's judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study." The 117-page study was issued in April 2021, and ultimately affirms the holding in Case C-528/16, stating that the "study makes it clear that organisms obtained through new genomic techniques [including CRISPR] are subject to the GMO legislation." Based on the study's findings, the European Commission requested public input on proposed legislation for "plants obtained by targeted mutagenesis and cisgenesis and for their food and feed products." The public consultation period expired on July 22, 2022. The European Commission plans to finalize the proposed framework in 2023.

United States Regulatory Landscape

In contrast to the EU approach, the United States does not currently regulate CRISPR-edited agricultural products as GMOs. The United States regulates biotechnology and genetic modification in food through a "Coordinated Framework" between the U.S. Department of Agriculture ("USDA"), Food and Drug Administration ("FDA"), and Environmental Protection Agency ("EPA").

At a high level, the USDA regulates the use of biotechnology in plant products through the Plant Protection Act. The USDA explains that the Plant Protection Act provides the USDA's Animal and Plant Health Inspection Service ("APHIS") with authority to regulate "organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering." Further, in 2018, the USDA's Agricultural Marketing Service promulgated the National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard"), which created a "new national mandatory bioengineered [] food disclosure standard" and associated recordkeeping requirements, effective January 1, 2022. The BE Disclosure Standard defines bioengineered food as food products that contain "genetic material that has been modified through in vitro [DNA]" and "for which the modification could not otherwise be obtained through conventional breeding or found in nature." Notably, the USDA has not explicitly clarified whether CRISPR-edited agricultural products are considered "bioengineered foods" and subject to the BE Disclosure Standard. Rather, in a presentation from 2020, the USDA stated that it "intends to make determinations about whether a specific modifications would be considered 'found in nature' or obtained through 'conventional breeding' on a case-by-case basis." (For more information on the BE Disclosure Standard, refer to Jones Day's May 2022 publication, Are Your Labels Up to Date? Assuring Compliance with the USDA's National Bioengineered Food Disclosure Standard.)

Additionally, the FDA regulates the use of biotechnology in plants with a focus on ensuring that foods are safe for human consumption. In 1992, the FDA issued a Statement of Policy regarding Foods Derived from New Plant Varieties, in which the FDA stated that "[t]he regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components)." Since then, the FDA has reviewed genetic modifications to food in the context of food additives, such that FDA approval is required to use food additives unless it is generally recognized as safe ("GRAS"). In the opinion of the FDA, a GMO is not GRAS if the altered substance "differs significantly in structure, function or composition from substances found currently in food." In contrast, a GMO is GRAS if it is "naturally occurring" in the food product, even if is bioengineered to be present at a "greater level" than found in nature or if there are "minor variations in molecular structure that do not affect safety." As explained in the introduction, CRISPR technology differs from conventional gene editing because it does not introduce new substances into a product that are not naturally present. Accordingly, CRISPR-edited agricultural products are not generally regulated by the FDA as food additives.

The EPA also reviews the use of biotechnology in plants, as it regulates the distribution, sale, and use of pesticides to ensure that they will "not pose unreasonable risks to human health or the environment when used according to label directions." Further, when the EPA evaluates plant-incorporated protectants ("PIPs"), which are genetically engineered pesticides, the EPA "requires extensive studies containing numerous factors, such as risks to human health, nontarget organisms, and the environment; potential for gene flow; and the need for insect resistance management plans." As such, CRISPR-edited pesticides may be regulated by the EPA as PIPs.

Conclusion

The patent and regulatory landscapes of the use of CRISPR technology in food are continuing to unfold across the world. Accordingly, agriculture companies and the broader agricultural industry should pay close attention to all developments.

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CRISPR Technology in the Agricultural Industry: Patent and Regulatory Updates - JD Supra

Gene therapy has witnessed a slight glimpse of hope after a new study led by the University of Bristol in England, United Kingdom, created a so-called "DNA repair-kit" technology.

The international team of researchers involved in the study claimed that the new technology can rewrite genetic codes and potentially repair hereditary diseases.

The UK-based lead researchers successfully fixed a hereditary kidney disease affecting children and young adults through patient-derived kidney cells using the DNA repair-kit.

The research is still at its infancy in the wider field of genetic studies. Yet, the study signifies it could raise hopes for gene therapy in the future.

Hereditary disease consists of a variety of medical conditions that are passed onto an offspring through the genetics of their parents or related family members in their immediate bloodline.

Through genetic codes, physiological and biological features of predecessors serve as an imprint of their appearance and health features.

For years, geneticists and other experts in related fields have engaged in a scientific quest to alter harmful or undesired genes, which have been considered before to be unavoidable or untreatable.

However, a growing body of academic literature shows genes can be changed through gene editing or genetic engineering.

(Photo : Photo by FRED TANNEAU/AFP via Getty Images)

In the paper published in the journal on Nucleic Acids Researchon July 8, the University of Bristol scientists targeted genetic mutations, which are the primary causes of hereditary diseases.

In particular, their study described how the DNA repair vehicle can fix a faulty genetic code called podocin.

Podocin is a protein normally located in the surface of specialized kidney cells and an essential kidney function.

Meanwhile, a faulty podocin is a common cause of the inheritable Steroid Resistant Nephrotic Syndrome (SRNS).

The difference between the health and unhealthy podocin is that the latter is stuck inside the kidney cell and never reaches the surface, which results in the terminal damage of podocytes.

Also Read:Butterfly Disease: New Gene Therapy May Help Treat People with the Rare Skin Disorder

The DNA repair-kit consists of protein-based scissors and nucleic acid molecules, along with DNA sequences to guide them replace the faulty gene, achieving the feat of what is known as rewriting genetic codes.

The National Human Genome Research Institutedescribes a genetic code as a set of instructions within the gene that tells a cell how to make protein.

Each code uses the four nucleotide bases of genetic letters of DNA such as: adenine (A), cytosine (C), guanine (G), and thymine (T).

Multiple studies, as compiled by the Walsh Medical Media, a peer-reviewed research site, showed that hereditary diseases are gene-based disorders passed from one generation to another.

The transfer of these conditions is made possible through a faulty or defective gene.

These genetic disorders are only transmitted in the same family.

In humans, the linear transmission from parent to offspring is caused by the chromosomes present in humans.

In the field of biology, chromosomes not only determine the biological sex of an individual but is also responsible for passing the genetic traits down the evolutionary ladder.

Related Article:Experts Discover New Disease Caused by Faulty Genes Affecting the Kidney and Liver: Newcastle University Study

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