With the rapid development of biotechnology, biopharmaceutical has become an important branch of the pharmaceutical industry. In this field, the role of parameter setting is especially prominent, which is directly related to production efficiency and product quality. The following will discuss the application and practice of parameter setting in the biopharmaceutical industry from different perspectives.

1. The key role of parameter setting in the biopharmaceutical production process

raw materials Parameter settings in the processing stage

In the raw material processing stage of biopharmaceuticals, parameter settings are crucial for the extraction and purification of raw materials.

(1) Extraction parameters: including solvent selection, concentration, temperature, time and so on. Reasonable parameter settings can improve the extraction rate and purity of target components.

(2) Purification parameters: such as ion exchange, gel filtration, affinity chromatography, etc., need to be adjusted according to the characteristics of the target substances, such as column material, flow rate, buffer and other parameters.

Parameter setting for fermentation process

Fermentation is the core part of biopharmaceuticals, and parameter setting has a decisive influence on the fermentation effect.

(3) Temperature: different strains of bacteria have different adaptability to temperature, and the optimal fermentation temperature needs to be set according to the characteristics of the strain.

(4) pH: Maintaining a suitable pH will help the growth of the bacteria and product synthesis.

(5) Dissolved Oxygen: Ensure that the amount of dissolved oxygen in the fermentation broth meets the needs of the strains by adjusting the stirring speed, aeration and other parameters.

Parameter settings in the post-processing stage

The post-processing stage includes product concentration, drying, preparation, etc., and parameter settings are equally crucial.

(6) Concentration parameters: such as temperature, pressure, time, etc., affecting concentration efficiency and product activity.

(7) Drying parameters: in the process of freeze-drying, the setting of parameters such as pre-freezing temperature, sublimation temperature, and resolving temperature are crucial for product quality.

2. Parameter settings in biopharmaceutical R&D

Parameter optimization in the laboratory pilot phase

At the lab pilot phase, the optimal conditions of the production process can be found through parameter optimization .

(1) Optimization of reaction conditions: the best reaction conditions are determined by means of one-factor experiments and response surface methodology.

(2) Optimization of medium formulation: adjust the ratio of carbon source, nitrogen source, growth factors and other components to improve the growth rate of the strain and product yield.

Parameter adjustment in the pilot scale-up stage

At the pilot scale-up stage, the parameters need to be adjusted according to the results of the laboratory small-scale test to adapt to large-scale production.

(3) Equipment selection: according to the requirements of the process parameters, select the appropriate fermenter, chromatography column and other equipment.

(4) Process optimization: adjust the operating steps, time and other parameters to ensure the stability and repeatability of the production process.

3. The role of parameter settings in biopharmaceutical quality control

Establishment and optimization of analytical methods

Establishment of highly efficient and accurate analytical methods is a quality control The parameter settings include:

(1) Detection conditions: e.g., chromatographic columns, mobile phases, and detection wavelengths.

(2) Standard curve: prepare the standard, determine the linear range, detection limit and other parameters.

Development of quality standards

According to the characteristics of the product, strict quality standards are formulated, including assay methods for content, purity, activity, and other indexes, as well as the criteria for determination.

Parameter setting has a pivotal position in the biopharmaceutical industry. From raw material handling, fermentation and post-processing, to research and development and quality control, precise parameter settings are indispensable in every step of the process. Through continuous optimization of parameters, biopharmaceutical companies can improve production efficiency, ensure product quality, so as to be invincible in the fierce market competition. In the future, with the further development of biotechnology, the importance of parameter setting will be more and more prominent, bringing more development space for enterprises.