Cell culture technology has a pivotal position in the field of biopharmaceuticals, providing strong support for the development and production of biological products. This paper focuses on how to improve the quality and yield of biopharmaceutical products from the point of view of cell culture parameter control, which provides reference for China's biopharmaceutical industry.

Biopharmaceuticals It refers to a class of drugs that are developed and produced by biotechnological means using living organisms or their components, such as cells, enzymes, antibodies, and so on. In recent years, with the rapid development of biotechnology, the biopharmaceutical industry has achieved remarkable results worldwide. In China, the biopharmaceutical industry also shows a booming trend. As a key technology in the field of biopharmaceuticals, the control of cell culture parameters has an important impact on product quality and yield.

Importance of cell culture parameter control

1. Impacts cell growth and metabolism

Cell culture parameters include temperature, pH, dissolved oxygen, nutrient substrate, hormone levels, etc., which directly affect cell growth, differentiation and metabolism. By accurately controlling these parameters, we can ensure that cells grow in an optimal state and improve the yield and quality of biopharmaceutical products.

1. Safeguard product safety

In the cell culture process, improper control of the parameters may lead to cell mutation, contamination, and other problems, which may affect product quality. Strict control of cell culture parameters helps to reduce potential risks in the production process and guarantee product safety.

1. Improve production efficiency

By optimizing the cell culture parameters, the growth rate of the cells and the expression level of the products can be improved, which can increase the production efficiency and reduce the production cost.

Cell culture parameter control strategy

1. }Temperature control

Temperature is one of the most important parameters in cell culture process. Different cells have different adaptation ranges to temperature, which is generally controlled between 36-38°C. Temperature fluctuations can affect cell growth and metabolism, therefore, a precise temperature control system should be used to ensure temperature stability during the culture process.

1. pH control

During the growth of the cells, the change of pH affects the nutrient uptake and metabolite excretion of the cells. In general, the pH of cell culture solution should be controlled between 7.2-7.4. Adopting a pH monitoring and regulation system to adjust the pH of the culture medium in real time helps cell growth.

1. Dissolved oxygen control

Dissolved oxygen concentration has an important effect on cell growth and metabolism. In general, the dissolved oxygen concentration during cell culture should be controlled at 20%-40%. Effective control of dissolved oxygen concentration can be realized by adjusting parameters such as stirring speed and aeration.

1. Nutrient matrix control

Nutrient matrix is the basis for cell growth, including sugar, amino acids, vitamins, minerals and so on. According to the needs of cell growth, rational allocation of nutrient matrix can help to improve the effect of cell culture.

1. Hormone level control

Hormones play a key role in the process of cell culture, such as growth factors and hormones. By adding appropriate amounts of hormones, cell growth and product expression can be promoted.

Examples of applications in the field of bio-pharmaceuticals

Taking recombinant protein drugs as an example, the expression level of recombinant proteins can be improved by optimizing cell culture parameters, thus increasing the yield. In addition, in the fields of vaccine production and antibody drugs, the control of cell culture parameters is equally important.

Control of cell culture parameters is a core element in the biopharmaceutical field. By optimizing parameters such as temperature, pH, dissolved oxygen, nutrient substrate, hormone levels, etc., cell culture effect can be improved to provide strong support for the biopharmaceutical industry. In the context of the rapid development of China's biopharmaceutical industry, in-depth study of cell culture parameter control technology is of great significance for improving product quality and reducing production costs.