With the rapid development of biotechnology, the biopharmaceutical industry has become increasingly prominent in China's economy. As an important part of biopharmaceutical industry, biopharmaceutical production support system is related to product quality, production efficiency and industrial competitiveness. This paper elaborates on the concept, classification, key technology and application of biopharmaceutical production support system, aiming to provide useful reference for China's biopharmaceutical industry.

Concepts and classifications of biopharmaceutical production support systems

1. Concepts

Biopharmaceutical production support system is a general term for a series of technologies, equipment, processes and management that provide material, energy, information and other resources for the production process of biopharmaceuticals to ensure smooth production. It includes raw material supply, production equipment, process flow, quality control, environmental monitoring, information management and other aspects.

2. Classification

According to the functional requirements of the biopharmaceutical production process, the biopharmaceutical production support system can be classified into the following categories:

(1) Raw material supply system: including the procurement of raw materials, storage, inspection, pretreatment and other links to ensure the quality of raw materials and supply stability.

(2) Production equipment system: including reactors, centrifuges, filters, mixers, filling machines, etc., providing hardware support for the production process.

(3) Process system: including strain cultivation, fermentation, extraction, purification, preparation, etc. to ensure product quality and yield.

(4) Quality control and testing system: to ensure product quality meets the specified requirements by monitoring the key indicators in the production process.

(5) Environmental monitoring and control system: real-time monitoring of the production environment to ensure that the production process is carried out under suitable environmental conditions.

(6) Informatization management system: real-time monitoring and management of production data, process parameters, equipment status, etc. is realized through informatization.

Key technologies of biopharmaceutical production support system

1. High-efficiency strain selection and breeding technology

Strains are the basis of the production of biopharmaceuticals, and the high-efficiency strain selection and breeding technology is of great significance to improve production efficiency. The efficient strain selection and breeding technology is important to improve the production efficiency. In recent years, the application of genetic engineering technology and metabolic engineering technology in strain selection and breeding has achieved remarkable results.

2. Fermentation engineering technology

Fermentation engineering technology is the core link of biopharmaceutical production, which mainly includes the control of fermentation process, the optimization of fermentation equipments, and the optimization of fermentation medium formulation. Through fermentation engineering technology, the growth rate of bacteria, product concentration and product yield can be improved.

3. Extraction and purification technology

Extraction and purification technology is a key step in the production of biopharmaceuticals, which directly affects product quality. Common extraction and purification methods include: solvent extraction, ion exchange, membrane separation, chromatography and so on.

4. Preparation technology

Preparation technology is to prepare biologically active substances into dosage forms suitable for clinical application. Biopharmaceutical preparation technologies include: freeze-drying technology, spray-drying technology, nano-preparation technology and so on.

5. Quality control and testing technology

Quality control and testing technology is an important means to ensure the quality of biopharmaceutical products. It mainly includes: high performance liquid chromatography, mass spectrometry, nuclear magnetic resonance, enzyme-linked immunosorbent assay and so on.

6. Informatization management technology

Informatization management technology realizes intelligent and refined control of the production process by constructing a platform for the collection, storage, analysis and application of production data.

In short, the biopharmaceutical production support system is of great significance in improving the quality of products, reducing the cost of production, and guaranteeing the safety of the industry. China's biopharmaceutical industry should increase the investment in research and development, innovate the key technologies of production support system, and enhance the overall competitiveness of the industry.