Biopharmacy is a branch of pharmacy that focuses on the research and production of biological drugs. A biological drug is a medication that contains one or more active substances derived from or isolated from living organisms and is intended for the treatment of diseases or genetic disorders. In the production of biological drugs, the process of protein solution concentration and buffer exchange plays a crucial role in biopharmaceutical purification. In older systems used for concentration processes, mass concentration monitoring of the protein solution during concentration is performed using scales and flow meters. With technological advancements, new devices have emerged that allow real-time measurement of mass concentration directly during the process. This master's thesis focuses on the use of Process Analytical Technology (PAT), which enables the monitoring of critical process parameters and provides real-time information on product quality during the process. The implementation of PAT involves advanced devices for real-time analysis, such as the CTech FlowVPX system, which measures the mass concentration of protein solutions using UV-Vis spectroscopy. The Sartoflow Advanced and PendoTECH systems consist of control elements and sensors necessary for carrying out protein concentration and buffer exchange processes and are used as the primary systems for these processes. In the master's thesis, the communication setup between the concentration system and the real-time analysis device was designed based on the OPC protocol (Object Linking and Embedding for Process Control Protocol), which is a communication protocol for the digital transfer of non-time-critical information, intended for connecting control systems with supervisory levels. Two versions of the protocol were described and used: OPC UA and OPC Classic. OPC UA ensures independence from operating systems and offers expandable security features, whereas OPC Classic requires a Windows operating system. The theoretical part of the thesis describes the process of concentration and buffer exchange, as well as the devices and technologies used in the study. The practical part involved testing various data exchange methods between systems, including the use of OPC tunnels and direct connections via a local network. The work includes technical descriptions of the devices used, the development and testing of OPC communication software, and the integration of measurement devices with process systems. Test results show that connecting devices using the OPC protocol enables process automation based on protein solution concentration values, improves measurement accuracy, and reduces the risk of human error. For comparison, an analog connection between devices was also established, demonstrating the shortcomings of such a connection. The implemented OPC-based solution facilitates the integration of Process Analytical Technology into process execution, while a similar solution can be applied to other laboratory systems.
|
