Construction Of PAT Technical Service Platform For Pharmaceutical Industries In The Middle Area Of Shandong Province

Currently, extensive production and management, backward technology and low levels of drug quality are widespread in the domestic pharmaceutical industry. Meanwhile, the state has launched a series of major special projects such as the major projects of National Drug Discovery in order to improve the overall national pharmaceutical industry innovation capacity and production levels and the technical areas include technological innovation of large variety and the key technological transformation.Shandong province is a large pharmaceutical province, which has one-tenth of the national pharmaceutical companies. Take Zibo and Weifang as core, the middle area of Shandong province is the main gathering area of pharmaceutical companies. The products of pharmaceutical companies in Shandong province are mainly focus on API and simple preparations and the GDP always rank first for many years. However, backward technology and equipment, low value-added products lead to the problems of quality instability, batch differences, low efficiency and others in the production process. The pharmaceutical companies need technical innovation and product quality improvement to enhance the market competitiveness. Therefore, the development of PAT platform is an effective way to solve this problem.PAT technology is based on the process analysis instruments or methods, through the analysis of the physical or chemical properties of substances in pharmaceutical process to realize comprehensive understanding of pharmaceutical processes. The PAT could significantly improve the quality and stability of the drug product, reduce production costs, improve production processes and environmental safety. These features of PAT fully fit the status of pharmaceutical industries in Zibo and could improve the weak link, improve the competitiveness and realize the industrial restructuring of these pharmaceutical industries.Based on the needs of the pharmaceutical industry, the objective and mission of PAT platform is the establishment of process analytical and monitoring technology for API, Chinese medicine and preparations. Through the construction and promotion of demonstration, the solutions for pharmaceutical companies were established and product quality and production efficiency could be improved.Based on the Things and cloud technology and facilities in Shandong University Zibo Biomedical Research Institute, through technology output, equipment supply, program customization, training and other means to establish personalized and customized service combines way to build a comprehensive, professional PAT technology network service system for pharmaceutical companies the middle area of Shandong province.The completion of the project could play active role in technical services, pilot production, industrial efficiency and quality improvement and greatly promote the development of the pharmaceutical industry in the middle area of Shandong province.This subject was funded by Shandong Province Science and Technology Development Program in December 2013. (No.2013GGX32113, R & D of shared technology for pharmaceutical process analytical technologies)...