Every mature industry will have relevant standards, so will pharmacy. When cooking, onions, ginger and garlic can be used as seasoning. If you put more, the taste of food will naturally change.

Drug analysis is somewhat similar. The API will have some impurities. If the impurity content is large, it will directly affect the effect of the drug after it enters the human body, even poisoning. Therefore, the industry standard is like a "cookbook", which has strict regulations on the impurity content, and "chefs" start "cooking" with it.

However, no matter how well the recipe is printed, if the chef is negligent or deviated in actual operation, the quality of the dishes can hardly be guaranteed. Therefore, in the process of drug "cooking", "gatekeepers" such as drug analysis are required to control the quality and safety, so as to benefit patients with a good drug with quality and quantity guaranteed.

Chen Bin, Vice President of CGeneTech Pharmaceutical Analysis. The first impression he gave was that he was gentle, prudent and rigorous. Especially when he presented the specific work of drug analysis with one armchair and the other, he really looked like our university teachers preaching!

"In the process of drug research and development, the raw materials are always mixed with impurities, heavy metals, genotoxic impurities and other harmful substances, which requires us drug analysts to carefully 'watch' them to continuously optimize and ensure removal." Listening to Chen Bin's earnestness when he said this, I thought of a song in my ear:

"His eyes stared like copper bells, shooting shrewdness like lightning."

Now please follow Sheng Xiaoke to listen to the "gatekeeper" ofCGeneTech in the field of drug analysis and talk about his feelings on drug research and development and industry development:

Sheng Xiaoke: What is the opportunity for you to choose the pharmaceutical industry and move to your current position?

Dr. Chen Bin: This is closely related to the research project during my doctoral research. At that time, the research project was to screen new drugs. There are three ways to screen new drugs: source of natural products, pharmaceutical synthesis and computer aided simulation design. The last one is the predecessor of AI pharmaceutical technology that is in the ascendant. What I studied during my doctorate was the source of natural products, screening and analyzing their biological activities from marine organisms such as marine earthworms through chemical separation and other means.

Because I have been doing research in this field, mastered the technical ideas of new drug development and pharmacodynamic experiments, and this field is also my interest, I directly entered the pharmaceutical industry after graduation, and have successively experienced in domestic and foreign new drug research and development institutions and companies in the field of drug analysis.

Sheng Xiaoke: Can you briefly describe the specific business of drug analysis and your daily work?

Dr. Chen Bin: Drug analysis runs through the whole life cycle of drug research and development. In short, it is to develop and formulate drug analysis methods, study the law of drug quality, and conduct comprehensive inspection and control of drugs by means of analysis and determination. Therefore, this field is very comprehensive, not only including chemical analysis, spectral analysis, chromatographic analysis, etc. in analytical chemistry, but also including data analysis, molecular biology analysis, etc.

Pharmaceutical analysis should not only be able to use instruments, but also learn to think, and develop analytical methods and standards more suitable for current product testing on the basis of existing facilities, instruments and various guidelines. This analytical method and standard is like the "eight times mirror" of a sniper gun. Various parameters with sensitivity, specificity, linearity and precision are used to "target" the impurities, heavy metals, genotoxic substances, etc. in the drug raw materials, find and ensure the removal or control one by one, and ultimately ensure the safety, effectiveness and quality control of the drug. This is also our core work.

Sheng Xiaoke: Please share what experience you have experienced since your career? What projects impressed you?

Dr. Chen Bin: Each career has brought me different growth and experience. In the early days when I joined a CRO company, I had a good "military training course". The company attaches great importance to the construction of the quality management system, and strictly requires the implementation of the quality system, which has given me a binding force in the process of drug research and development, and has formed a good habit of standardization and normalization.

Later, when I was in a pharmaceutical enterprise, I was responsible for process analysis and quality research as an analysis director. I needed to lead a team of more than 80 people, and promote the development of nearly 50 projects. Finally, 7 products were reported for production and listing. In this process, I need to fully understand the whole process of drug research and development, application, registration, drug supervision and verification, so as to cultivate an individual's overall view of work and the management ability to lead the team.

Sheng Xiaoke: What are the characteristics of innovative biotechnology companies in your eyes?

Dr. Chen Bin: First of all, it is necessary to have an international core management team to layout innovative products from the perspective of global innovation, and use the international experience of the full life cycle of drugs to operate and implement. Secondly, it is necessary to create a unique and differentiated technology platform, which can continuously develop innovative products with clinical value.

Sheng Xiaoke: What kind of projects do you think are FIC?

Dr. Chen Bin: FIC drugs must be new in the world. It is the first product of the target to be listed in the world. It will bring great feedback effects to enterprises, patients and industries. For example, the FGFR/VEGFR double target small molecule inhibitor CGT-6321 independently developed by the company is expected to become a potential first in class new drug of this kind of double target inhibitor in the field of treating solid tumors in China because of its triple effects of inhibiting tumor cell growth, anti angiogenesis and regulating tumor immune microenvironment due to its highly selective kinase inhibitory effect.

Sheng Xiaoke: What hobbies do you have besides work?

Dr. Chen Bin: My hobbies mainly focus on sports. I used to love football, basketball and badminton, but now I focus more on running as I grow older. Run for 20-30 minutes every morning. Jogging allows me to enjoy the beauty of the morning, breathe fresh air, and enjoy the joy of sports. Proper exercise can also bring vitality to the work of the day.