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 normal2 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 in4 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)
More information
2020
11-03
Jinhua Municipal Party Committee Secretary Chen Long: I wish your enterprise better and better
On the morning of October 16, Chen long, secretary of the Jinhua Municipal CPC Committee, and his entourage came to the construction site of Jianfeng Pharmaceutical's internationalization project to investigate and affirmed the good development status and clear future development ideas of Jianfeng Pharmaceutical. At the construction site, Jiang Xiaomeng, chairman of the group company and chairman of the pharmaceutical company, introduced the overall situation of the investment scale, factory layout, and production direction of the Jianfeng Pharmaceutical internationalization project to Chen Long and his entourage. Huang Jinlong, general manager of the pharmaceutical company, accompanied Chen Long and his entourage to visit the preparation workshop under construction. The construction site is neat, tidy and orderly, and the facilities and equipment are perfect and advanced, all have been unanimously affirmed by the leaders who came to investigate. When learning that the peak internationalization project has introduced international advanced equipment, built in accordance with European and American standards, and its products are oriented to the international market, Chen long said happily: "your goals are very clear and your thinking is very clear. I wish your enterprise better and better!" (this newspaper reporter)
2020
10-23
Liu Haiping, vice mayor of Pu'er City, said during the survey: "Peak is an enterprise with feelings"
On September 30, Liu Haiping, member of the standing Committee of the Pu'er Municipal CPC Committee and vice mayor of Pu'er City, Yunnan Province, and relevant responsible persons of Pu'er City and Simao District, visited the company for investigation and research, and communicated with the leaders of the group company on topics such as further strengthening cooperation between the two sides. "Yunnan Jianfeng has not only developed well in Pu'er these years, achieved good benefits and contributed considerable tax revenue, but also made great contributions to promoting the economic development of Pu'er and the stability of the southwest border region. It is our 'star enterprise' and 'baby enterprise '." Liu Haiping said so in the exchange. He said that Pu'er is an important window for the implementation of the "Belt and Road" concept. It has good conditions in natural resources, transportation, electricity, etc., and the peak is a "sentimental enterprise" and has a good foundation in the local area. Strengthen cooperation; various government departments will also earnestly "stand on the platform" and "do a good job as a shopkeeper" to serve enterprises. Chairman Jiang Xiaomeng and General Manager Yu Jianhong exchanged views with Liu Haiping and his party on the layout of peak industry and strengthening cooperation with Pu 'er. After that, accompanied by General Manager Yu Jianhong and Deputy General Manager Huang Jinlong, Liu Haiping and his party visited the Jinxi Factory of Jianfeng Pharmaceutical Factory. (this newspaper reporter)
2020
10-09
The first batch of Jianfeng Pharmaceuticals to enter Jinhua (Shanghai) Science and Technology Center
News from our newspaper On September 16, at the unveiling ceremony of the Yangtze River Delta G60 Jinhua (Shanghai) Science and Technology Innovation Center and Jinhua (Shanghai) Talent Building, Jiang Xiaomeng, chairman of the group company and chairman of the pharmaceutical company, took over from Chen Long, secretary of the Jinhua Municipal Party Committee. The golden key with big red flowers. Spike Pharmaceuticals became one of the first seven companies to enter the center. The Yangtze River Delta G60 Jinhua (Shanghai) Science and Technology Center and Jinhua (Shanghai) Talent Building are the first "Science and Technology and Talent Enclave" in Shanghai in the nine cities of the Yangtze River Delta G60 Science and Technology Corridor, and the first cross-regional industrial collaborative innovation center in the Science and Technology Corridor. The center is located in Shanghai Lingang Songjiang Science and Technology City, with a total area of nearly 10,000 square meters. It includes two parts: science and technology innovation and talent service. There are five major centers, including talent service center, science and technology innovation exhibition center, business incubation center, enterprise research and development center, and talent project roadshow center. It is a science and technology innovation platform that integrates the functions of project incubation, recruitment of institutions, and talent recruitment. Chen Long, secretary of the Jinhua Municipal Party Committee, said in his speech at the unveiling ceremony that in the future, all scientific and technological enterprises stationed in Jinhua (Shanghai) Science and Technology Center and Talent Building can equally enjoy Jinhua's local science and technology and talent policies, so as to further break the space limitation, enable talents from the two places to share the most favorable treatment and convenient services, help enterprises to develop in Shanghai and achieve industrialization in Jinhua. At the ceremony, leaders such as Chen Long, secretary of the Jinhua Municipal Party Committee, and Cheng Xiangmin, secretary of the Shanghai Songjiang District Party Committee, awarded seven companies, including Jianfeng Pharmaceutical, the golden key to symbolize their entry. At the Yangtze River Delta Integrated Talent Cooperation Project Symposium held after the ceremony, Jiang Xiaomeng spoke as a representative of Jinhua entrepreneurs. He believed that Shanghai, as an international metropolis, has an agglomeration effect on high-end intellectual resources and grasps the first-class element resources of scientific and technological innovation in China and even the world. The establishment of G60 Jinhua (Shanghai) science and technology innovation center and talent building in the Yangtze River Delta helps Jinhua enterprises to take off in scientific and technological innovation and information exchange, which will provide strong and continuous scientific and technological support and intellectual support for the long-term development of enterprises in the future, and attract more excellent domestic and foreign talents to serve Jinhua enterprises, It plays a key role in further improving scientific research ability, innovation ability and personnel training. During the event, Jiang Xiaomeng successively accepted on-site interviews with "People's Daily", "Liberation Daily", "Zhejiang Daily" and other media. He said that the establishment of science and technology innovation and talent bases in Shanghai has greatly enhanced Jinhua's attractiveness to enterprises. "With this base, we don't need to introduce talents to Jinhua, but directly recruit talents in Shanghai, and at the same time enjoy Jinhua's various talent recruitment policies, and change Shanghai talents to Jinhua's use. This is a kind of bold. The innovation has greatly solved the dilemma of attracting talents for enterprises." As a settled enterprise, it will also make full use of its own advantages to continuously inject resource vitality into the science and technology innovation center, and continue to contribute to the long-term development of Jinhua's economy. (this newspaper reporter)
2020
09-22
Spike Pharmaceutical Added New Products
On September 3, Spike Pharmaceutical Company received the approval of the State Drug Administration for the registration of esomeprazole sodium for injection (approval number: 2020S00572). Esomeprazole sodium for injection is mainly used to treat low-risk patients with gastroesophageal reflux disease and acute gastric or duodenal ulcer bleeding when oral therapy is not applicable. It has been listed in the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2017 Edition) ", classified as Class B. According to industry statistics, 30 companies including Zhengda Tianqing and Qilu Pharmaceutical have been approved for listing in China. In 2019, domestic sales (including urban and county-level public hospitals, community and township health centers) were about 3.317 billion yuan. Jianfeng Pharmaceutical submitted an application for registration of esomeprazole sodium for injection to the State Food and Drug Administration in November 2013 and was accepted. Up to now, Jianfeng Pharmaceutical has invested nearly 15 million yuan in research and development for the project and has a corresponding production line. This time to obtain the injection of esomeprazole sodium drug registration approval, marking the peak pharmaceutical has the drug production, sales qualification, will further enrich the peak pharmaceutical product line, help to enhance the competitiveness of the peak pharmaceutical business. (Lu Yating, Liu Yang)
2020
09-11
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