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Daily accumulation is the cornerstone of paving the road to success

Release time:

2021-03-12

Pharmaceutical Company 2020 Outstanding Scientific and Technological Worker Pharmaceutical Company Product Development Department Liu Yang

I have been engaged in the research and development of bulk drugs since I entered the company in 2013 . I cherish the title of "Tech Worker " , because to have technology is to have the power of innovation, to create unlimited possibilities. Therefore, as workers in the pharmaceutical industry, we must have a pattern that is in line with the domestic first-class pharmaceutical companies, and we must also dare to establish the ideal of catching up with the world's advanced level of medicine. We have the responsibility and ability to make technological breakthroughs become an important force in the development of our enterprises. After so many years of research and development work, I know very well that the nature of scientific and technological work requires the accumulation of a lot of basic work, repeated verification and attention to details, and finally qualitative changes can be caused by quantity.

Looking back on the past year, it was full and full of difficulties and challenges. Last year, it was notified in January 19 that the National Evaluation Center would conduct on-site verification of the esomeprazole sodium project we declared in February 21 4 . However, the process of raw materials has not been verified on the modified equipment. It only took more than 3 months and the Spring Festival holiday in the middle. We only had the chance to find problems in production in batch 1 trial production. We used batch 2 to verify the feasibility of the production plan. Batch 4 as the on-site dynamic verification batch must be safe. During the trial production, there were many problems, such as excessive impurities in the products and blocking materials during the preparation of intermediates. It can be said that the operation of the trial production process was not smooth, and the quality of the products obtained was not good. As soon as the trial production is over, we will summarize all the problems in time and analyze the reasons step by step. For example, the impurity exceeding the standard is due to the key process of the project: the reaction conditions required for oxidation reaction are relatively harsh, and the new equipment in the workshop cannot do experiments like in the laboratory, and the temperature control and feeding are very accurate. While we were discussing how to increase the ability of equipment control through small improvements, we were thinking hard about other countermeasures, and the on-site operator said: "This side of the fine process is simply not suitable for large-scale production! " This sentence made me suddenly realize that I used to think that the more detailed and accurate the process, the better, but now it seems to be a misunderstanding. Because if the operating parameters of a process are very accurate, every production should be more careful, which will undoubtedly increase the risk of production failure. However, if the parameters of the process are in a very wide range, the operator can ensure the product quality as long as he follows the relevant procedures and does not need very fine operation. Of course, the process with wide parameters is better. Therefore, with this idea in mind, I came back to consult the literature, read the summary of previous experiments, analyzed the reaction conditions of the oxidation process one by one, and proved my idea through 10 batch of small-scale experiments. After that, the conditions for the oxidation reaction were appropriately relaxed, and at the same time, with the improvement of equipment, in the following batches of production, the key process was basically stable, impurities were controllable, and the reaction law was clear.

In addition, the problem of intermediate blocking the pipeline occurred during the trial production, which not only affected the quality and yield of the product, but also increased the difficulty of the production operation. A simple crystallization rejection and filtration process can be completed in normal

2 hours, and our trial production took more than 8 hours. This intermediate itself is easy to agglomerate quickly. We have many methods to deal with agglomeration in the laboratory trial production process, but it is completely impossible to enlarge the production. If this difficult problem is not solved, the on-site verification will definitely fail. In the face of this problem, I pondered hard for a few days. The experimental phenomena that I had done before kept flashing in my mind. It suddenly occurred to me that this intermediate had a very short forming period when it was separated out. The key to solving the agglomeration lies in this short forming period. It hasn't come out earlier, and it has already formed hard lumps if it is later, so when I do this step of production, I will keep a close eye on the forming time. As soon as the forming period arrives, I will immediately increase the stirring speed and cooperate with the impact of the air flow to prevent the material from forming hard lumps. Finally, after 2 batch production attempts, the problem was successfully solved and the production cycle was greatly shortened.

Through the concerted efforts of various departments, esomeprazole sodium successfully passed the on-site dynamic inspection in

4 and the compliance inspection of GMP in 11 , and successfully obtained the production license. In addition to the esomeprazole sodium project, last year I also did a lot of work for the verification of imatinib mesylate application, which ensured the smooth progress of the verification production now.

shared so much, I think as a scientific and technological worker, we should not only have lofty ideals and firm confidence, but also pay attention to basic work, be patient and not let go of details. Ideal and confidence are like road signs, and the accumulation of daily work is the cornerstone of paving the road to success. The two complement each other and are indispensable. Only in this way can we truly achieve

"to set up a peak ambition and make a high-quality medicine " , turn our work into an important part of promoting the development of the company and grow together with the enterprise.

(according to Liu Yang's speech at the summary commendation meeting of the pharmaceutical company)

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