Four common manufacturing processes of APIs

API is the premise of pharmaceutical preparation production. In each link of pharmaceutical industry chain, API plays the role of processing and manufacturing of basic pharmaceutical industry raw materials, and most of them are outsourced production. API drug outsourcing process service refers to pharmaceutical companies entrust other pharmaceutical RESEARCH and development institutions to carry out API outsourcing process research and production. The production process of API includes chemical synthesis, fermentation, animal and plant extraction, etc.

According to the source obtained, APIs are generally divided into chemical synthesis APIs, animal and plant extraction APIs and production fermentation and cell culture APIs. APIs are also divided into non-sterile APIs and sterile APIs according to the microbiological level of the product and the target dosage form. Typical API manufacturing processes are as follows:

1.Chemical synthesis API production process

Chemical synthesis API refers to the production method of API in which various chemical raw materials in industrial production are chemically reacted to produce products with certain efficacy under certain conditions, and then crystallization, drying and other processes are carried out to achieve various indicators of drugs.

2.Fermentation API production process

Fermentation is also one of the important methods of API production, especially for antibiotic API, such as penicillins and cephalosporins. It is usually obtained semi-synthetic by a combination of fermentation and chemical synthesis. Firstly, the main structure of the target compound was obtained by biological fermentation, such as the penicillin specific 3-lactam structure, and then the final target compound was obtained by structural modification. Finally, after refined recrystallization, the final API product is obtained. The fermentation process generally needs to go through the preparation of culture medium, elimination tank treatment, inoculation, fermentation, wall breaking, filtration, precipitation, centrifugation, drying and other processes.

3.Sterile API production process

Similar to sterile preparations, sterile APIs are also divided into sterile APIs that are ultimately sterilized and sterile APIs that are not ultimately sterilized. However, as most APIs are sensitive to high temperature, high humidity and high pressure, and radiation, few sterile APIs that are ultimately sterilized are used. Compared with non-sterile API, the production of sterile API not only needs to pay attention to the requirements of chemical quality indicators such as impurities and physical and chemical properties of the product, but also needs to pay attention to the guarantee of sterility of the product from the beginning of process design. Therefore, the production of sterile API has higher requirements on environment and equipment.

4.Plant and animal extraction API production process

Nature is a treasure house of natural compounds. Through their own metabolism, animals or plants produce many compounds that cannot be synthesized at present but are of great significance to the treatment of diseases. Therefore, animal and plant extraction is an important way to obtain target compounds, as well as one of the main ways to produce APIs. In the process of API research and development and production, the main drug production quality management. The quality management standard of drug production is based on production, and only with production can there be quality. The quality of drugs is produced, not inspected, and the production and management of drugs is in accordance with GMP.

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