In the biopharmaceutical industry, parameter settings are crucial to ensure the efficiency, stability and product quality of the production process. In this paper, we will discuss the key parameter settings in the biopharmaceutical process, analyze the factors affecting the parameter settings, and propose optimization strategies, with a view to providing useful references for industry practitioners.

Biopharming It refers to drugs produced by using biotechnology, including recombinant protein drugs, antibody drugs, vaccines and so on. In recent years, with the rapid development of biotechnology, biopharmaceuticals have become increasingly prominent in the pharmaceutical market. However, the biopharmaceutical production process is complex and involves numerous parameter settings. Reasonable parameter settings are important for improving production efficiency, reducing costs and ensuring product quality.

Critical parameters in the biopharmaceutical process

1. Temperature

Temperature is one of the most critical parameters in the biopharmaceutical process. It directly affects the activity, stability and product quality of biocatalysts (e.g., enzymes, cells). Different biopharmaceutical processes have different temperature requirements, generally between 30-40°C.

2. pH value

pH value has a significant effect on the activity and stability of biocatalysts. Reasonable setting of pH value can improve the production efficiency. In the biopharmaceutical process, the pH value is generally controlled between 6-8.

3. Dissolved oxygen

Dissolved oxygen refers to the solubility of oxygen in solution. In the process of biopharmaceuticals, the dissolved oxygen level plays an important role in cell growth, metabolism and product synthesis. In general, the dissolved oxygen level is controlled between 20% and 40%.

4. Nutrient concentration

Nutrients are the material basis for growth, reproduction and product synthesis of biocatalyst. Reasonable configuration of nutrient concentration helps to improve production efficiency. It mainly includes carbon sources, nitrogen sources, inorganic salts and so on.

5. Inducer concentration

The inducer is a key factor in regulating the expression of target products by biocatalysts. Too high or too low inducer concentration will affect the product synthesis. Therefore, it is crucial to optimize the inducer concentration.

Factors affecting the parameter settings

1. Types of biocatalysts

Different biocatalysts have different requirements for the production conditions, so the parameter settings need to be adjusted according to the characteristics of the biocatalyst.

2. Production process

Differences in production process will lead to differences in parameter settings. For example, fermentation process, cell culture process, etc.

3. Equipment performance

Equipment performance directly affects the accuracy of parameter control. High-performance equipment helps to realize precise control and improve production stability.

4. Production scale

Changes in the production scale will lead to adjustments in parameter settings. For example, scaling up the production process requires consideration of mass and heat transfer.

Optimization strategy

1. Model-based parameter optimization

By building a mathematical model of the biopharmaceutical process, the key parameters are simulated and optimized to realize the optimal control of the production process.

2. Experimental design method

Using the experimental design method (e.g., response surface methodology, analytic design, etc.) to optimize the key parameters and to improve the production efficiency.

3. Data mining and analysis

Collecting data generated in the production process and analyzing them by using data mining techniques to discover the potential laws and provide a basis for parameter setting.

4. Intelligent control

Using artificial intelligence, big data, and other technologies, intelligent control of the biopharmaceutical process can be realized to improve the accuracy and real-time of parameter setting.

Parameter setting in the biopharmaceutical industry is crucial. Through in-depth research and optimization of key parameters, it helps to improve production efficiency, reduce costs, and ensure product quality. With the continuous progress of biotechnology, the biopharmaceutical industry will develop in the direction of more intelligent and precise in the future, and the importance of parameter settings will be further highlighted.