| Lyophilized human coagulation factor â…§ (Fâ…§) is obtained from fresh frozen plasma of healthy people by the productions steps of separation, purification, viral inactivation treatment and freeze-drying. Fâ…§ is used for the prevention and treatment of hemophilia and acquired coagulation factor â…§ deficiency caused by bleeding, as well as the surgery hemorrhage patients in clinical. Due to the lack of plasma resources and the lagging behind in production technology, the supply of FVID in clinical is short for a long time. In our country, less than 10% of hemophilia patients can get regular treatment. April 17th of each year is "the World Hemophilia Day".Fâ…§ with a low content in blood is easy to be inactivated. Especially in the industrialization, the final product yield of active protein in domestic is 7%, and the highest active protein yield internationally is only 19%, resulting in a waste of valuable resources. How to separate Fâ…§ from plasma with high yield, high specific activity and high security has been a bottleneck in the domestic and foreign blood products industry. Compared with blood products industry in developed countries, there is a wide gap in technology development, engineering, process optimization, process control and other aspects in domestic ones. Thus, in order to integrate with the international, domestic enterprises must continue to study new technology to optimize the production process and process control. This is also the eternal theme for every blood products enterprise.The main task of this paper is to explore the control factors of manufacturing process of Fâ…§ and top-level design and establish key operating platform in industrialization.After the screen of critical manufacturing processes and the analysis of critical control points, the international advanced online control technology and near infrared spectroscopy technology was brought to use for quality control of key processes in industrialization of Fâ…§. The module of key quality control points of the process or process control analysis unit was established to guide the key technical parameters precise setting and optimal parameters combination. The implement of online monitoring and quality control of the key production processes could improve the yield of trace protein Fâ…§, ease clinical needs and improve the economic benefits of enterprises. Through the establishment of the model drug near infrared spectroscopy online monitoring system, the exploration will be proceeded to extend this technology to the entire industrial production process. If it will be effectively promoted, the industrial upgrading of blood products industry will be achieved and product intrinsic quality will be improved.Innovations and significance:The manufacturing processes was first described and analyzed systematically in industrialization in the domestic. Process analytical technology was used for the process quality control of Fâ…§ product, realizing key processes online monitoring and quality control of Fâ…§ products, and establishing key process control points and online analysis module.Because of the complexity of Fâ…§ industry technological process and the limited time, we can only select 3-4 key processes to implement analysis and control research. Beside, because of the limitations of various conditions, the laboratory studies were finished and conception in industrialization was put forward. Application of process analysis technology has not yet been put into the industrialization stage. |
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