Northland achieves 500L regulation of naked plasmid gene the
It is reported that Beijing Northland Biotechnology Co., Ltd. recently completed the preparation of phase III clinical samples of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection", with a production scale of 500L. According to the survey, the 500L-scale preparation of naked plasmid gene therapy drugs is the largest production scale reached for the first time in the world so far.
Naked plasmid refers to plasmid DNA that does not bind proteins, lipids or other molecules that have a protective effect on it. Because it has the ability to replicate autonomously and can express the genetic information it carries, it is used in biopharmaceutical, agricultural, food and other industries , Especially widely used in the biopharmaceutical field. Naked plasmid gene therapy drugs use naked plasmid vectors to introduce foreign genes into target cells and express corresponding proteins in the body to achieve the purpose of treating diseases. With the rapid development of gene therapy drugs, the research and application of naked plasmid gene therapy drugs have received extensive attention from research institutions and pharmaceutical companies. As of November 2017, there are approximately 428 clinical programs (including DNA vaccines) using naked plasmid gene therapy drugs worldwide, of which 320 are in phase I clinical phase, 91 are in phase II clinical phase, and phase III clinical There are 17 stages.
Up to now, no naked plasmid gene therapy drugs have been approved for the market worldwide. Most naked plasmid production is in laboratory and pilot scale. Only a few companies in the United States, Germany, Japan and other countries can professionally prepare naked plasmid gene therapy drugs. Its scale is basically 100-200L. The large-scale production of naked plasmids is an urgent problem to be solved in realizing the industrialization and commercialization of naked plasmid gene therapy drugs.
The "recombinant human hepatocyte growth factor naked plasmid injection" developed by Northland is a naked plasmid gene therapy drug composed of pCK vector and heterozygous hepatocyte growth factor gene. Phase II clinical research has been completed. The realization of 500L scale production of the drug is a major breakthrough in the development of naked plasmid gene therapy drugs and a necessary prerequisite for the company to carry out phase III clinical trials. Through years of hard work, the Northland scientific research team has overcome technical problems in naked plasmid fermentation, pretreatment, purification and other links, continuously optimized process parameters and conditions, and independently created the "NL-DNA-Tech" naked plasmid gene therapy drug production technology. The production process is stable, the product quality is reliable, and it meets the requirements of large-scale production.
The clinical sample of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection" produced by Northland has a yield of more than 60%, a purity of more than 97%, and a supercoil ratio of more than 90%. All tests are in line with the product's specifications. Quality Standard.
Mr. Xu Songshan, Chairman of Northland, said: The successful preparation of samples for phase III clinical trials of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection" is not only a test of the company's scientific research capabilities, but also a phase III clinical trial of this product. A guarantee for smooth development is of great and far-reaching significance. The company will continue to carry out relevant research, further expand the scale of production, and will build an automated and intelligent world-leading large-scale production system for naked plasmid drugs. (apichina)
Naked plasmid refers to plasmid DNA that does not bind proteins, lipids or other molecules that have a protective effect on it. Because it has the ability to replicate autonomously and can express the genetic information it carries, it is used in biopharmaceutical, agricultural, food and other industries , Especially widely used in the biopharmaceutical field. Naked plasmid gene therapy drugs use naked plasmid vectors to introduce foreign genes into target cells and express corresponding proteins in the body to achieve the purpose of treating diseases. With the rapid development of gene therapy drugs, the research and application of naked plasmid gene therapy drugs have received extensive attention from research institutions and pharmaceutical companies. As of November 2017, there are approximately 428 clinical programs (including DNA vaccines) using naked plasmid gene therapy drugs worldwide, of which 320 are in phase I clinical phase, 91 are in phase II clinical phase, and phase III clinical There are 17 stages.
Up to now, no naked plasmid gene therapy drugs have been approved for the market worldwide. Most naked plasmid production is in laboratory and pilot scale. Only a few companies in the United States, Germany, Japan and other countries can professionally prepare naked plasmid gene therapy drugs. Its scale is basically 100-200L. The large-scale production of naked plasmids is an urgent problem to be solved in realizing the industrialization and commercialization of naked plasmid gene therapy drugs.
The "recombinant human hepatocyte growth factor naked plasmid injection" developed by Northland is a naked plasmid gene therapy drug composed of pCK vector and heterozygous hepatocyte growth factor gene. Phase II clinical research has been completed. The realization of 500L scale production of the drug is a major breakthrough in the development of naked plasmid gene therapy drugs and a necessary prerequisite for the company to carry out phase III clinical trials. Through years of hard work, the Northland scientific research team has overcome technical problems in naked plasmid fermentation, pretreatment, purification and other links, continuously optimized process parameters and conditions, and independently created the "NL-DNA-Tech" naked plasmid gene therapy drug production technology. The production process is stable, the product quality is reliable, and it meets the requirements of large-scale production.
The clinical sample of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection" produced by Northland has a yield of more than 60%, a purity of more than 97%, and a supercoil ratio of more than 90%. All tests are in line with the product's specifications. Quality Standard.
Mr. Xu Songshan, Chairman of Northland, said: The successful preparation of samples for phase III clinical trials of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection" is not only a test of the company's scientific research capabilities, but also a phase III clinical trial of this product. A guarantee for smooth development is of great and far-reaching significance. The company will continue to carry out relevant research, further expand the scale of production, and will build an automated and intelligent world-leading large-scale production system for naked plasmid drugs. (apichina)
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