The biopharmaceutical industry, as a strategic emerging industry in China, has achieved world-renowned results in recent years. With the continuous development of biotechnology, the production process of biopharmaceuticals has become increasingly complex, and the requirements for quality control in the production process have become higher and higher. Process Analytical Technology (PAT), as an emerging technology, has been widely used in biopharmaceutical production. In this paper, the application of PAT technology in biopharmaceutical production and its value will be introduced in detail.

1. Definition: PAT technology refers to the on-line analysis, control, and optimization of the production process through real-time monitoring of the key quality parameters and performance indicators in the production process, thus ensuring product quality. PAT technology is a technical means to realize on-line analysis, control and optimization of the production process through real-time monitoring of key quality parameters and performance indexes in the production process, so as to ensure stable product quality and improve production efficiency.

2. Principle: PAT technology utilizes advanced analytical instruments, sensors and data processing systems to monitor key parameters in the production process in real time, such as temperature, pressure, humidity, pH, dissolved oxygen, etc., and transmits these data to the control system for analysis and processing. Through real-time monitoring of the production process, online prediction and regulation of product quality is realized.

3. Classification: According to the different means of monitoring, PAT technology can be divided into the following:

(1) Spectroscopic analysis technology: such as UV-visible spectroscopy, infrared spectroscopy, Raman spectroscopy, etc.;

(2) Chromatographic analysis techniques: such as high-performance liquid chromatography, gas chromatography, etc.;

(3) Electrochemical analysis techniques: such as potentiometric analysis, current analysis, etc.;

(4) Sensor technology: such as temperature sensors, pressure sensors, humidity sensors, etc..

Applications of PAT technology in biopharmaceutical production

1. API production: in the process of API production, PAT technology can be used to monitor the key parameters such as the composition of the reaction solution, its concentration, and the process of reaction, so as to achieve the optimization of the reaction conditions, and to increase the yield and the Product quality.

(1) Spectral analysis technology: By monitoring the ultraviolet-visible spectra of the reaction solution, real-time analysis of the concentration changes of the components in the reaction solution, which provides the basis for the optimization of the reaction conditions;

(2) Sensor technology: The use of sensors, such as temperature, pressure, humidity and so on, to monitor the environmental parameters in the reaction process in real time. monitoring of environmental parameters during the reaction process to ensure stable reaction conditions.

2. Cell culture: During cell culture, PAT technology can be used to monitor key parameters such as cell density, viability, metabolites, etc., to achieve optimization of the culture process.

(1) Spectral analysis technology: analyze cell density and metabolite concentration by monitoring the UV-visible spectra of the culture solution;

(2) Sensor technology: utilize dissolved oxygen sensors, pH sensors, etc., to monitor the culture environment in real time to ensure that the cell growth conditions are Stabilization.

3. Preparation production: In the process of preparation production, PAT technology can be used to monitor the key parameters such as particle size, shape, content, etc., to improve the quality of the preparation.

(1) Spectral analysis technology: analyze the shape and content of particles by monitoring the UV-visible spectrum of the particles;

(2) Chromatographic analysis technology: use high-performance liquid chromatography (HPLC) to monitor the content of raw materials and excipients to ensure the quality of the preparation is stable.

Value of PAT technology

1. Improve product quality: Ensure stable product quality and reduce the rate of non-conforming products through real-time monitoring of key parameters in the production process;

2. Optimize the Production process optimization: According to the monitoring data, adjust the production process in time, realize process optimization, and improve production efficiency;

3. Reduce production costs: Reduce the waste in the production process, reduce energy consumption, and lower production costs;

4. Improve production safety: Real-time monitoring of safety hazards in the production process, reduce the rate of nonconforming products;

4. safety hazards in the production process to ensure production safety;

5. Enhance the competitiveness of the enterprise: adopt advanced technical means to improve product quality and production efficiency, and enhance the competitiveness of the enterprise in the market.

The application of PAT technology in the production of biopharmaceuticals is of great significance. With the rapid development of China's biopharmaceutical industry, PAT technology will be more widely used to provide strong support for the sustainable development of China's biopharmaceutical industry. Enterprises should fully recognize the importance of PAT technology, increase investment, promote the application of PAT technology in production, improve product quality and production efficiency, and make greater contributions to China's biopharmaceutical industry.