In recent years, China's bio-pharmaceutical industry has made rapid progress, and pharmaceutical companies' investment in bio-pharmaceuticals has shown an increasing state. More and more companies hope to increase research and development efforts and strive to achieve new breakthroughs. In the biopharmaceutical industry, medium optimization is an essential part from laboratory to industrial production, and an important method to increase the expression of products, which plays an important role. Designing and optimizing a good medium is a key step for pharmaceutical companies to develop pharmaceutical products that will make them successful. Xu Cuiyun, Director of Process Development, Shanghai Fuhong Hanlin Biotechnology Co., Ltd. However, there are still many companies in the process of designing and optimizing the medium. In order to help enterprises solve problems in the optimization process, Sartorius, who has made outstanding achievements in the field of biotechnology, specially invited Ms. Xu Cuiyun from Fuhong Hanlin, and Xu Cuiyun answered questions on related issues. In response to a current statement in the industry: For specific clones, optimization and development of the medium is required, and Xu Cuiyun agrees. She believes that different clones, target gene sequences, and sites where gene sequences are inserted are different. This may result in changes in cell metabolism, such as glycosylation, lactic acid, sugar, and the like. Therefore, the composition of the medium required will vary. "If we want this cell to grow well enough and the yield is high enough, then we will develop the medium according to its characteristics to adapt to its growth, so I think different clones still need to develop the medium for its characteristics. ." Since different clones need to be developed for the characteristics of the culture medium, pharmaceutical companies should also "prescribe the right medicine" for the different problems in the medium optimization process. The author understands that Xu Cuiyun has 11 years of experience in monoclonal antibody and cell culture, and is familiar with upstream processes, media development, and reactor amplification processes. Combining years of experience in the industry, she said that the main problem facing the medium in the optimization process is the method. “The development of the medium is a difficult task for us. The whole process requires a lot of manpower and material resources. Of course, in the process, I think the most important thing is the method of the medium.†Xu Cuiyun said, usually The most used method in the medium optimization process is DOE. If a company needs to use a DOE, it must have a high-throughput device to support it. Therefore, in addition to good methods, companies should not ignore equipment factors. Xu Cuiyun also said, "Individually, when I develop the medium, I usually check the amino acids, vitamins, trace elements and other ingredients of the medium, so I think it is more important to have suitable detection methods." In addition, Xu Cuiyun It is also added that the difference between the batch and the batch of the medium should not be too large, and if the difference between the batches is too large, the effect of different batches of cell culture may be different. Therefore, it is also critical to choose the right medium manufacturer. Combined with the above analysis, it is summarized that in the medium optimization process, pharmaceutical companies need to consider and pay attention to the medium method, high-throughput equipment, detection methods, batch-to-batch differences, and medium producers. Only by combining these factors will the medium optimization process go smoothly. In addition, for the optimization of the medium, it has also been proposed how to balance the relationship between the expression amount and the product quality. In this regard, Xu Cuiyun put forward his own views. “For pharmaceutical companies, I think quality must be the first.†In the pharmaceutical industry, quality cannot be ignored. “In terms of a new project, the first thing to look at is whether the quality of production can meet the standards. If it is not up to standard, then I usually Will adjust the culture conditions, culture medium, make this quality pass, and then consider the issue of production. As a result, the output will be improved to some extent." However, it takes a lot of time to have a high quality product. Under normal circumstances, a project has more urgent time requirements, and process optimization requires sufficient time to support. How to balance the relationship between medium optimization and project schedule has become a topic of concern for many companies. Xu Cuiyun believes that it is very necessary to develop several platform-based media in process development. Usually the platformized medium can support the most basic requirements, as well as the quality and relative production requirements, which will enable the project to move forward first. "For example, first report the clinical, then go to the second phase of the clinical direction. In the third phase of the clinical, in fact, you can make some small changes. However, the degree of change is appropriate to have to do their own evaluation." Xu Cuiyun said, if The change is too great, and the drug regulatory department may ask for some requirements, such as adding some experimental data or clinical data. But overall, companies can use platform-based media to improve progress early in the project. I believe that through the detailed explanation of Xu Cuiyun, many companies have a certain understanding of the related problems and solutions in the medium optimization process. In the medium optimization process, whether it is the relationship between method, equipment, balance quality and yield, or the correct handling of the contradiction between medium optimization and project schedule, pharmaceutical companies should consider it. Only in this way can the project be promoted smoothly. Go ahead and reach your final goal. Character introduction: Xu Cuiyun Upstream Process Development Director Shanghai Fuhong Hanlin Biotechnology Co., Ltd. Ms. Xu Cuiyun graduated from Southeast University School of Medicine and obtained a master's degree in Cell Molecular Biology from Tongji University. He worked in Jiahe Bio-Pharmaceutical Co., Ltd. for 5 years and held the position of cell culture supervisor. In 2011, Ms. Xu Cuiyun joined Shanghai Fuhong Hanlin Biotechnology Co., Ltd., a joint venture between Shanghai Fosun Pharmaceutical (Group) and the team of American scientists in December 2009, mainly engaged in monoclonal antibody biosimilar drugs and organisms. The research and development and industrialization of improved drugs and innovative monoclonal antibodies mainly cover areas such as tumors and autoimmune diseases. Ms. Xu is mainly responsible for cell line construction, upstream early and late process optimization, pilot scale amplification and GMP production support. With 11 years of monoclonal antibody and cell culture experience, Ms. Xu is very familiar with upstream process, medium development and reactor amplification process. She has participated in many projects from small test process optimization to GMP production and IND declaration. And as a technical core personnel involved in the project NDA declaration. During her time at Fuhong Hanlin, she has won numerous awards for outstanding management, outstanding employees and innovations, and won the Shanghai Youth May Fourth Medal in 2015. Lip Balm,Tinted Lip Balm,Glossier Lip Balm,Fresh Lip Balm Guangzhou Lingxue Cosmetics Co., Ltd , https://www.gzlxgj188.com