It is reported that as of July 2020, Yangzijiang Pharmaceutical Group has a total of 32 varieties and 39 quality regulations through consistency evaluation, of which 15 varieties are the first to be evaluated in the same variety in the country, supporting the growth of these numbers is a 1,600 professional scientific research team, which continues to escort the innovative growth of Yangzijiang Pharmaceutical Group, Kang Xingkai is one of them.
Kang Xingkai, graduated from Hebei University of Technology, joined Haiyan Pharmaceutical Research Institute of Yangzijiang Pharmaceutical Group as a synthesis researcher on December 7, 2015. "I have always believed that professional people and professional companies do professional things. For pharmaceutical companies, Yangzijiang Pharmaceutical Group is best at drug development, manufacturing and quality control." He recalled the original choice vividly, but what moved him more was the corporate mission of "pharmaceutical for parents, pharmaceutical for relatives".
Condensing mirror, test to compare the weight of the shoulders
Haiyan Pharmaceutical Research Institute has established an efficient operating mechanism and research and development system with reference to international standards. Kang Xingkai is mainly responsible for the work of pharmaceutical chemical synthesis. So far, he has completed the pilot test of 7 batches of raw materials, the production transfer of 1 batch, and the process verification of 3 batches. The project he is responsible for has completed a DMF filing, and has also completed the issuance and replacement work of the project. He said that behind these achievements are the hard work of Dr. Chen Dong leading our research and development team day and night.
The institute will encounter many problems and challenges in the process of promoting new projects, Kang Xingkai said that he regards research and development work as a sacred mission, and strive to achieve perfection in every challenge. He remembers a project in the early days where the difficulty was that the finished product exceeded the limit of inorganic salts. The inorganic salt can be removed by adsorption, but API will have a chemical reaction with medicinal carbon resulting in over-limit, molecular sieve adsorption method can remove inorganic salt, but the production workshop does not have the ability to activate molecular sieve, so it is necessary to find a method that can remove inorganic salt but also easy to achieve industrialization, and can not affect other API indicators. After his repeated trials and explorations, he finally found the silica gel interception method, a simple, easy, stable and reliable method, successfully realized the industrialization of the project and completed the declaration.
Reverence R & D "three diligent four" to promote the long
Independent innovation, to be an original pharmaceutical company with independent intellectual property rights in China, is the dream of all our R & D personnel. Therefore, Kang Xingkai is always in awe of the work, and the experimental process of each product is completed in strict accordance with the standard process. He said that with the advancement of the project, he has also made continuous progress and gained a lot. For example, during the whole process from project initiation to project application, I had a clear understanding of the R&D process of generic drugs. In the writing of application materials, I changed the manuscript several times, which greatly improved my ability to write data. Keeping an eye on policies and regulations gives me a deeper understanding of industry dynamics.
Talking about the institute and colleagues, Kang Xingkai said the most is grateful, Yangzijiang Pharmaceutical Group has enough expenses to invest in new product research and development every year, and has layout in many fields, as a research and development personnel, to have better performance. This time, I was awarded the Advanced Individual in 2020 by the Pharmaceutical Research Institute of the Group, which is the group's recognition of my efforts and affirmation of my work ability. I will work harder in the future, so as to "think hard, summarize frequently, strive hard, have faith, have responsibility, and have dedication", and move forward together with colleagues through thick and thin in the future!