From September 9th to 10th, 2019, Suzhou CMC-EXPO China was successfully launched 2019. Dr. Ma Jianguo, Vice President of the Ministry of Crafts Department of the Ministry of Technology, will give a speech, "The Application of Green Chemical Technology in the Pharmaceutical Industry." Here we interview Dr. Ma in advance. In the interview, Dr. Ma gave us knowledge about green chemistry's research and development and production strategies and introduced its impact on the administration research circle.
Jianguo Ma
Vice President of CMC Department
Dr. Jianuo Ma, Vice President of the CMC of Shanghai Meidicilon, Bachelor and Master of Chemistry at the Department of Chemistry of Lanzhou University, Ph.D. at the UNIVERSITY of Montreal University, and postdoctoral chemistry at Harvard University. Dr. Ma has many years of research and development experience in a new types of drugs, leaders, and participation in several major innovative drugs and generic drug research projects. Dr. Ma has experience in researching and developing raw drugs and intermediate production technology. It has developed over 20 raw materials and many drug intermediates with cost advantages and intellectual property commercial production technology. At the same time, he vigorously developed new technologies, including continuous reactions and biocatalytic, and applied these technologies to commercial production.
Q&A
Q1: What is green chemistry, and what is the core of the thought it conveys?
Dr. Ma:
The concept of green chemistry dates back to the United States in the 1980s and was formally proposed in the Pollution Prevention Act promulgated in 1990. At that time, this concept was mainly concerned with the relationship between chemical research and development and production and the environment, and the green chemistry we mentioned today has more meanings of the dimension.
I think the core concept of green chemistry is mainly reflected in three points: the first is security, the second is to reduce the "three wastes," and the third is to reduce costs. For more detailed explanations of green chemistry, refer to the "12 principles of green chemistry". This principle has explained a clear interpretation of the concepts and applications of green chemistry.
Dr. Ma:
In recent years, many emerging technologies have been carried out around green chemistry—typical biological enzyme catalytic technology, continuous reactions, optical oxidation reactions, hydrogen reactions, etc.
Enzyme chemistry is the frontier area of current international chemistry, and there is also much room for development. Last year's Nobel Prize was also awarded for the directional evolution of enzymes.
Q3: How does enzyme chemical technology achieve the purpose of "green chemistry"? What is the significance of developing enzyme chemical technology?
Dr. Ma:
Enzyme chemistry refers to the use of biological enzymes to catalyze chemical reactions. This type of reaction uses water as a solvent to catalyze the reaction in the aquatic solution, and water can be said to be the greenest solvent;
Second, biological enzymes can catalyze some reactions that need high-risk conditions in traditional methods, such as high temperature and high pressure to synthesize, such as the production of carbon bonds. Such reactions can be completed mildly under the action of biological enzymes to reduce danger and danger and danger and reduce risk and cost;
Third, biological enzyme technology can perform three-dimensional selective reactions. For example, some hand-made molecular structures have improved the three-dimensional selectivity of chemical reactions;
In addition, biological enzyme technology is more critical to expand the path of drug synthesis significantly and to making many drugs that are difficult to synthesize with traditional synthetic technologies. The development of enzyme chemistry is of great significance.
Q4: The process of enzyme catalytic technology? What are the commonly used enzyme catalysts?
Dr. Ma:
The source of enzymes is usually through the fermentation of microorganisms or the cultivation of animal cells. Scientists express the designed enzyme-gene sequences through these two expression systems to obtain structural-functional biomass. After that, according to the needs of actual production, you can catalyze the chemical reactions that contain enzyme cell suspension or are separated from the crude or purified enzyme to add to the reaction system.
There are many industrial enzyme catalysts. Three of the most common are ester hydrazides, ketones, and aminotransferase.
Q5: How does the Ministry of Crafts of the Medicilon practice "green chemistry"? What can we bring to customers and pharmaceutical companies in this way?
Dr. Ma:
The Ministry of Crafts Department of Midi Si is mainly engaged in preclinical drugs, newly listed raw materials, generic drugs, research and development, process optimization, and large-scale production from GMP standard intermediates, providing customers with the integration of chemistry, production and control solutions to the integration of solutions Service. Since joining Midi in 2017 and setting up the business team of the Department of Technology, I have always integrated the concept of "green chemistry" into the craftsmanship exploration design and production process. In addition to the enzyme chemicals mentioned above, Midi Si also puts continuous reaction technology into the process synthesis, which can safely complete the high-risk reactions that some traditional intermittent reactors cannot complete. In exploring the synthetic path, we also try to avoid the reaction conditions of high temperature and high pressure, avoid the generation of toxic waste, and practice "green chemistry" from design ideas.
As for the benefits of "green chemistry" that it can bring to customers of pharmaceutical companies, there are too many. First, reducing three wastes and increasing atomic utilization can save materials and reduce costs; the reaction conditions tend to mild the expenses generated, on the one hand, can keep the safety of extreme reaction conditions such as high temperature and high pressure. Third, no toxic substances are produced, making it a safer choice for companies and consumers.
Q6: In what aspects can the Ministry of Craft Department of the Midi Sien optimize the customer's research and development process?
Dr. Ma:
In addition to the green chemistry industry, the Ministry of Crafts of the Meidi Crafts has a strict quality research system that can control the requirements of genetic poison impurities and metal element impurities in raw medicine, meet the needs of the principles of regulations and ICH guidance, and help customers complete the project smoothly; We also have a CGMP platform, which successfully developed the raw drugs for innovative drugs for more than 20 pharmaceutical companies or the ingredients used for imitation drugs used for consistency evaluation.
Conclusion
"Green Chemistry" is a big project that benefits and benefits society. It is a slogan and an effective measure to help enterprises in long-term sustainable development. The Midi Capital Department is willing to work with you to actively explore the road of "green chemistry" to add a touch of green to the
synthesis of API.
Medicilon can undertake the synthesis of special reagents, intermediates and molecular fragments, preparation of standard products, synthesis design and preparation of impurities or metabolites, synthesis of stable isotope internal standards and synthesis of tritiated compounds.
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