In the Laboratory of Life Sciences of Wuhan University, there is a row of petri dishes under a bright fluorescent lamp, and a young rice seedling just grows long, slender leaves. Next to an experimental bench, Wuhan University professor Yang Daichang picked up a glass bottle containing half a bottle of pale yellow rice. In this seemingly common glutinous rice endosperm, there is precious human serum albumin.
On October 31, 2011, the American Academy of Sciences published the research paper of Yang Daichang's research group on “The large-scale production of recombinant human serum albumin by genetically modified rice.†The paper describes the good prospects: The cultivation of transgenic rice in paddy fields can produce recombinant human serum albumin in its endosperm cells, which is currently a scarce substance that can only be extracted from human plasma.
This news rapidly occupied news releases including scientific media such as Nature and Science, and then landed on major news media in the world. The title of the “Time†magazine’s related story was awesome: Extruding human blood from rice?
Albumin blunts human serum albumin is an important protein in the human body, accounting for about 30% of the total blood of healthy people. In hospital pharmacies, medical human serum albumin injections are viscous, pale yellow liquids called "life-saving drugs," which are commonly used for blood loss, shocks caused by burns, and treatment of critical illnesses such as liver ascites and cancer. In the treatment of hypoproteinemia, 5g/20ml of human serum albumin reagent can maintain the osmotic pressure of the body, equivalent to 100ml of plasma or 200ml of whole blood. In addition, as a stabilizer, human serum albumin is also widely used in pharmaceutical production such as vaccines.
According to a rough estimate, China needs 150 tons-170 tons of human serum albumin per year for clinical and vaccine excipients. At present, almost all human serum albumin in the world is extracted from human plasma. In China, the amount of plasma needed to produce human serum albumin is equivalent to 100 million annual blood donations for 200 million people.
In reality, plasma supply falls far short of production requirements, and human serum albumin is often urgent. The shortage of raw materials is also a common situation among many albumin manufacturers since the remediation of illegal blood collection and plasma supply reduction in 2006.
The National Development and Reform Commission's pricing of price-limiting drugs requires a price of 360 yuan per 10 grams of human serum albumin at 50 ml/bottle. Due to supply shortage, its black market prices tend to double. The huge interest space has attracted counterfeiters.
In 2007, CCTV's "Weekly Quality Report" was exposed. More than 2,000 bottles of counterfeit human serum albumin preparations entered the market and even appeared on the drug racks of some public hospitals in Jilin Province. Subsequently, the State Food and Drug Administration carried out special rectification of human serum albumin across the country and seized counterfeited human serum albumin in Jilin, Shanxi, Qinghai, Hubei, Shandong, Liaoning, Chongqing, and Xinjiang.
Until 2008, there were news reports that several patients in Jiangsu died of fake human serum albumin made by injecting propolis with water.
"Creating" albumin When the fake albumin mixed with the intensive care unit makes people feel paralyzed, Professor Yang Daichang of Wuhan University began to "plant" the experiment of human serum albumin in the rice field. Now, the yellowish rice in his glass bottle contains human serum albumin.
These rice are grown using transgenic technology, implanted with genes that produce human serum albumin. However, unlike genetically modified food crops, which are increasingly known to the general public, in this process, the transformed rice is no longer used as a food product but only as a bioreactor for the production of human serum albumin.
In the development of transgenic technology, the first and second generations of transgenic products focus on improving the resistance to pests and diseases of food crops, increasing nutrition, and improving the taste, while industries like “hematopoietic rice†are used as industrial, pharmaceutical, and bioreactors. The third generation of genetically modified products is currently becoming a hot spot in international genetic engineering research.
Professor Yang Daichang has been studying the expression of specific proteins through rice for many years. He chose rice because China took the lead in completing the sequencing of the rice genome and had a clear biological background, providing technical support for the high-level expression and purification of recombinant proteins. In addition, the rice transgenic technology is very mature. As a self-pollinated plant, biosafety is better. Moreover, the high rice propagation coefficient makes it easier to achieve scale.
"Technology is not complicated." Yang Daichang told Caixin "the new century [14.15 0.64% stock bar research report]" that the research team will be a specific human gene through genetic carriers, integrated into a rice genome, forming a new rice variety. During the growth of this rice, designated proteins are expressed in rice seeds by transcription and translation of the gene. That is, during the maturation of rice, human serum albumin is continuously synthesized and accumulated in the endosperm of rice.
"When the rice seeds are mature, they can extract a large amount of human serum albumin from them," Yang said. As a scholar, he is also chairman of Wuhan Haoyuan Biotechnology Co., Ltd. (hereinafter referred to as Qianyuan Company). In the company's factory building on the outskirts of Wuhan, albumin is being separated from mature rice in several stainless steel containers and purified to become the final product.
Yang Daichang stated that the production of human serum albumin by genetic engineering was not his first initiative. As early as 1987, attempts to produce albumin using genetically modified bacteria had a precedent. “Later use of yeast, transgenic cows, and other mammalian cells did not produce very good results.†Research has also been conducted on the expression of albumin by plant cells. In the United States and Canada, researchers have successfully “sown†white potatoes from potatoes. protein.
"Because of the lack of yield, these studies are limited to the laboratory and cannot meet industrial production." Yang Daichang often said, "In theory, using genetically modified plants to produce human serum albumin can avoid blood transfusions and pass blood The risk of virus transmission, but low yield, high cost and difficulty in scale, are three problems that restrict the industrial production of albumin."
However, these problems seem to have been resolved in the study of Yang Daichang. Nature magazine reported that William Velander, a genetic engineering therapist at the University of Nebraska-Lincoln, said that compared to using human plasma to make albumin, Yang’s method is used on a large scale. , security is better and more cost-effective.
Every kilogram of rice planted in this way can produce 2.75 grams of finished human serum albumin preparation, which is considered to be of considerable economic value in the industry.
In the 30 acres of land rented by a company in a certain rural area of ​​Hubei Province, Qianyuan Company has harvested the "hematopoietic rice" harvested this year; in the laboratory, they are making further improvements to the rice seeds.
Yang Daichang often said, “Our rice seed has no change in its activity for three years at room temperature, and its expression in the seed can maintain its stability for seven generations or more.â€
Yang Daichang introduced that there are already more than 80 kinds of medicines produced by transgenic plants. At present, more than 10 kinds have entered the second and third phases of clinical practice. According to reports in Nature, Yang Daichang has already submitted the first clinical trial application to the US Food and Drug Administration. He hopes to test the safety of human serum albumin grown from rice in two years.
Yang Daichang stated that the significance of using rice to successfully produce albumin on a large scale is to set a precedent for plant expression of human proteins and open up a pathway. Medically, the use of human serum albumin is usually calculated in grams. When the expression of human serum albumin is achieved, some other smaller amounts, such as antibodies and factors, can reach milligrams and micrograms of protein. Realize mass production.
"Why do I choose such a difficult subject to do? As long as this is done, we can achieve a large-scale production and the plant will be able to pass through this road." Yang Daichang often revealed that his research group is still studying the production of other medicines through plants, such as insulin.
The road to “blood production†is long Yang Daichang’s office is located on a small two-story building in Wuhan University’s campus. In front of the building is a small experimental field covered with wire mesh. In late autumn, rice that has not yet been harvested swaying golden rice ears.
Yang Daichang told Cai Xinxin that “the new century [14.15 0.64% shares bar research report]†reporter, his 30 acres of experimental fields almost strictly comply with the national requirements for the cultivation of genetically modified crops. General GM crops must not have the same crop around 100 meters, and there are no other rice within five kilometers of his experimental plot. The Ministry of Agriculture carried out on-site inspections twice a year. Qianyuan also purchased specialized harvesters and dryers. “The buffer zone was built on every field side. Even if someone occasionally wanted to get it on the field hoe, they wouldn’t get it. How much we would recycle, and 1 gram will not flow out.â€
Intermediate trials, environmental releases, and subsequent production trials are the necessary stages before the Ministry of Agriculture can obtain a commercial planting safety certificate for GM crops. After a GM variety has passed these stages, whether it can obtain a safety certificate is still a question mark.
At present, China has issued only two kinds of genetically modified rice, Huahui 1 and Bt Shanyou 63. These two types of rice have gone through a long period of 11 years from the beginning of the trial to the final safety certificate.
According to an expert on genetically modified rice, who did not wish to be named, even in the wake of the security certificate in 2009, in the controversy surrounding public opinion, the two recently-ripened rice have not yet been commercialized.
Yang Daichang also knows how difficult it is to advance research to obtain a safety certificate. "We want to do productive experiments now, but our country is not in this piece of legislation."
Yang Daichang often disclosed that he learned that relevant departments are doing research on the approval system for related products. As the evaluation and approval of medical and industrial genetically modified products, the current reference is made to the agricultural safety certificate system. After obtaining the certificate, a series of procedures are followed, and the seed company is eventually promoted. “Our products do not need to be promoted, how much they grow, how much they receive, do not enter the market, and do not enter the food chain.â€
For Yang Daichang’s research, a rice expert stated that the use of plants to express human serum albumin is theoretically feasible. However, the selection of rice, the staple food of most people in China, as a bioreactor is debatable.
"It's not that genetically modified rice that contains human serum albumin is harmful. This protein is no problem. It doesn't matter if people eat it. But if rice becomes the main body of a bioreactor and expresses something else, In the food chain, the consequences are terrible."
“I think the relevant departments will be very cautious when it comes to approval.†The expert said that China's GMO management system is very complete, even more stringent than the United States and the European Union, but it is not perfect in practice. For example, the illicit cultivation of genetically modified rice varieties that had caused great controversy earlier was not deliberately flowed out by researchers, but it was a problem in concrete implementation. Rice is a plant with a high rate of reproduction. Once seeds are accidentally spilled, it is difficult to control and not enter the food chain.
"After all, from the appearance, you have no way to tell." The rice expert said.
On October 31, 2011, the American Academy of Sciences published the research paper of Yang Daichang's research group on “The large-scale production of recombinant human serum albumin by genetically modified rice.†The paper describes the good prospects: The cultivation of transgenic rice in paddy fields can produce recombinant human serum albumin in its endosperm cells, which is currently a scarce substance that can only be extracted from human plasma.
This news rapidly occupied news releases including scientific media such as Nature and Science, and then landed on major news media in the world. The title of the “Time†magazine’s related story was awesome: Extruding human blood from rice?
Albumin blunts human serum albumin is an important protein in the human body, accounting for about 30% of the total blood of healthy people. In hospital pharmacies, medical human serum albumin injections are viscous, pale yellow liquids called "life-saving drugs," which are commonly used for blood loss, shocks caused by burns, and treatment of critical illnesses such as liver ascites and cancer. In the treatment of hypoproteinemia, 5g/20ml of human serum albumin reagent can maintain the osmotic pressure of the body, equivalent to 100ml of plasma or 200ml of whole blood. In addition, as a stabilizer, human serum albumin is also widely used in pharmaceutical production such as vaccines.
According to a rough estimate, China needs 150 tons-170 tons of human serum albumin per year for clinical and vaccine excipients. At present, almost all human serum albumin in the world is extracted from human plasma. In China, the amount of plasma needed to produce human serum albumin is equivalent to 100 million annual blood donations for 200 million people.
In reality, plasma supply falls far short of production requirements, and human serum albumin is often urgent. The shortage of raw materials is also a common situation among many albumin manufacturers since the remediation of illegal blood collection and plasma supply reduction in 2006.
The National Development and Reform Commission's pricing of price-limiting drugs requires a price of 360 yuan per 10 grams of human serum albumin at 50 ml/bottle. Due to supply shortage, its black market prices tend to double. The huge interest space has attracted counterfeiters.
In 2007, CCTV's "Weekly Quality Report" was exposed. More than 2,000 bottles of counterfeit human serum albumin preparations entered the market and even appeared on the drug racks of some public hospitals in Jilin Province. Subsequently, the State Food and Drug Administration carried out special rectification of human serum albumin across the country and seized counterfeited human serum albumin in Jilin, Shanxi, Qinghai, Hubei, Shandong, Liaoning, Chongqing, and Xinjiang.
Until 2008, there were news reports that several patients in Jiangsu died of fake human serum albumin made by injecting propolis with water.
"Creating" albumin When the fake albumin mixed with the intensive care unit makes people feel paralyzed, Professor Yang Daichang of Wuhan University began to "plant" the experiment of human serum albumin in the rice field. Now, the yellowish rice in his glass bottle contains human serum albumin.
These rice are grown using transgenic technology, implanted with genes that produce human serum albumin. However, unlike genetically modified food crops, which are increasingly known to the general public, in this process, the transformed rice is no longer used as a food product but only as a bioreactor for the production of human serum albumin.
In the development of transgenic technology, the first and second generations of transgenic products focus on improving the resistance to pests and diseases of food crops, increasing nutrition, and improving the taste, while industries like “hematopoietic rice†are used as industrial, pharmaceutical, and bioreactors. The third generation of genetically modified products is currently becoming a hot spot in international genetic engineering research.
Professor Yang Daichang has been studying the expression of specific proteins through rice for many years. He chose rice because China took the lead in completing the sequencing of the rice genome and had a clear biological background, providing technical support for the high-level expression and purification of recombinant proteins. In addition, the rice transgenic technology is very mature. As a self-pollinated plant, biosafety is better. Moreover, the high rice propagation coefficient makes it easier to achieve scale.
"Technology is not complicated." Yang Daichang told Caixin "the new century [14.15 0.64% stock bar research report]" that the research team will be a specific human gene through genetic carriers, integrated into a rice genome, forming a new rice variety. During the growth of this rice, designated proteins are expressed in rice seeds by transcription and translation of the gene. That is, during the maturation of rice, human serum albumin is continuously synthesized and accumulated in the endosperm of rice.
"When the rice seeds are mature, they can extract a large amount of human serum albumin from them," Yang said. As a scholar, he is also chairman of Wuhan Haoyuan Biotechnology Co., Ltd. (hereinafter referred to as Qianyuan Company). In the company's factory building on the outskirts of Wuhan, albumin is being separated from mature rice in several stainless steel containers and purified to become the final product.
Yang Daichang stated that the production of human serum albumin by genetic engineering was not his first initiative. As early as 1987, attempts to produce albumin using genetically modified bacteria had a precedent. “Later use of yeast, transgenic cows, and other mammalian cells did not produce very good results.†Research has also been conducted on the expression of albumin by plant cells. In the United States and Canada, researchers have successfully “sown†white potatoes from potatoes. protein.
"Because of the lack of yield, these studies are limited to the laboratory and cannot meet industrial production." Yang Daichang often said, "In theory, using genetically modified plants to produce human serum albumin can avoid blood transfusions and pass blood The risk of virus transmission, but low yield, high cost and difficulty in scale, are three problems that restrict the industrial production of albumin."
However, these problems seem to have been resolved in the study of Yang Daichang. Nature magazine reported that William Velander, a genetic engineering therapist at the University of Nebraska-Lincoln, said that compared to using human plasma to make albumin, Yang’s method is used on a large scale. , security is better and more cost-effective.
Every kilogram of rice planted in this way can produce 2.75 grams of finished human serum albumin preparation, which is considered to be of considerable economic value in the industry.
In the 30 acres of land rented by a company in a certain rural area of ​​Hubei Province, Qianyuan Company has harvested the "hematopoietic rice" harvested this year; in the laboratory, they are making further improvements to the rice seeds.
Yang Daichang often said, “Our rice seed has no change in its activity for three years at room temperature, and its expression in the seed can maintain its stability for seven generations or more.â€
Yang Daichang introduced that there are already more than 80 kinds of medicines produced by transgenic plants. At present, more than 10 kinds have entered the second and third phases of clinical practice. According to reports in Nature, Yang Daichang has already submitted the first clinical trial application to the US Food and Drug Administration. He hopes to test the safety of human serum albumin grown from rice in two years.
Yang Daichang stated that the significance of using rice to successfully produce albumin on a large scale is to set a precedent for plant expression of human proteins and open up a pathway. Medically, the use of human serum albumin is usually calculated in grams. When the expression of human serum albumin is achieved, some other smaller amounts, such as antibodies and factors, can reach milligrams and micrograms of protein. Realize mass production.
"Why do I choose such a difficult subject to do? As long as this is done, we can achieve a large-scale production and the plant will be able to pass through this road." Yang Daichang often revealed that his research group is still studying the production of other medicines through plants, such as insulin.
The road to “blood production†is long Yang Daichang’s office is located on a small two-story building in Wuhan University’s campus. In front of the building is a small experimental field covered with wire mesh. In late autumn, rice that has not yet been harvested swaying golden rice ears.
Yang Daichang told Cai Xinxin that “the new century [14.15 0.64% shares bar research report]†reporter, his 30 acres of experimental fields almost strictly comply with the national requirements for the cultivation of genetically modified crops. General GM crops must not have the same crop around 100 meters, and there are no other rice within five kilometers of his experimental plot. The Ministry of Agriculture carried out on-site inspections twice a year. Qianyuan also purchased specialized harvesters and dryers. “The buffer zone was built on every field side. Even if someone occasionally wanted to get it on the field hoe, they wouldn’t get it. How much we would recycle, and 1 gram will not flow out.â€
Intermediate trials, environmental releases, and subsequent production trials are the necessary stages before the Ministry of Agriculture can obtain a commercial planting safety certificate for GM crops. After a GM variety has passed these stages, whether it can obtain a safety certificate is still a question mark.
At present, China has issued only two kinds of genetically modified rice, Huahui 1 and Bt Shanyou 63. These two types of rice have gone through a long period of 11 years from the beginning of the trial to the final safety certificate.
According to an expert on genetically modified rice, who did not wish to be named, even in the wake of the security certificate in 2009, in the controversy surrounding public opinion, the two recently-ripened rice have not yet been commercialized.
Yang Daichang also knows how difficult it is to advance research to obtain a safety certificate. "We want to do productive experiments now, but our country is not in this piece of legislation."
Yang Daichang often disclosed that he learned that relevant departments are doing research on the approval system for related products. As the evaluation and approval of medical and industrial genetically modified products, the current reference is made to the agricultural safety certificate system. After obtaining the certificate, a series of procedures are followed, and the seed company is eventually promoted. “Our products do not need to be promoted, how much they grow, how much they receive, do not enter the market, and do not enter the food chain.â€
For Yang Daichang’s research, a rice expert stated that the use of plants to express human serum albumin is theoretically feasible. However, the selection of rice, the staple food of most people in China, as a bioreactor is debatable.
"It's not that genetically modified rice that contains human serum albumin is harmful. This protein is no problem. It doesn't matter if people eat it. But if rice becomes the main body of a bioreactor and expresses something else, In the food chain, the consequences are terrible."
“I think the relevant departments will be very cautious when it comes to approval.†The expert said that China's GMO management system is very complete, even more stringent than the United States and the European Union, but it is not perfect in practice. For example, the illicit cultivation of genetically modified rice varieties that had caused great controversy earlier was not deliberately flowed out by researchers, but it was a problem in concrete implementation. Rice is a plant with a high rate of reproduction. Once seeds are accidentally spilled, it is difficult to control and not enter the food chain.
"After all, from the appearance, you have no way to tell." The rice expert said.
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