The process types of APIs mainly include the following:
Synthesis process: APIs are synthesized by chemical reactions. This process usually requires the design of synthesis routes, the selection of catalysts and the control of reaction conditions.
Semi-synthesis process: APIs are prepared by chemical transformation using natural products or existing compounds as starting materials. This process requires the selection of appropriate reaction conditions and enzyme catalysis.
Bioprocess: APIs are synthesized by organisms such as microorganisms, plants or animal cells. This process requires the selection of appropriate organisms, culture conditions and fermentation process control.
Extraction process: APIs are extracted from natural plants, animals or microorganisms. This process requires the selection of appropriate extraction methods and extraction process parameter control.
Full chemical synthesis method: Production is carried out in accordance with the declaration method of chemical drugs. The production of APIs and preparations can be separated, which is convenient for outsourcing and production flexibility.
Biological fermentation method: The target product is obtained by microbial fermentation. It is often used in the production of antibiotic APIs and has also been widely used in the production of other types of APIs in recent years.
These process types have their own advantages and disadvantages and are suitable for different API production needs. For example, the cost of biological fermentation is close to that of chemical method in small-scale production, but it has more cost advantages in large-scale production because its basic materials are starch and other target products obtained through cell fermentation, while the chemical method requires the purchase of raw materials such as amino acids, which has relatively high costs.
