Industry Information

Ulinastatin Manufacture: From Discovery to Market

  Ulinastatin is a natural protease inhibitor that has been used in the treatment of various inflammatory conditions, such as acute pancreatitis and sepsis. Its effectiveness is attributed to its ability to inhibit a wide range of enzymes involved in the inflammatory response. The pharmaceutical industry has been interested in developing Ulinastatin as a drug, leading to the establishment of a production process that meets regulatory standards and ensures high-quality products.

  Discovery of Ulinastatin:

  Ulinastatin was first isolated from the urine of healthy human subjects in the 1980s. Its inhibitory activity against trypsin, a digestive enzyme, was identified, leading to further research into its protease inhibitory properties. In the following years, several other enzymes were found to be inhibited by Ulinastatin, including elastase and chymotrypsin, which are involved in the inflammatory process.

Ulinastatin Manufacture: From Discovery to Market

  Production Process:

  The production of Ulinastatin involves the cultivation of a specific strain of bacteria, followed by the purification of the protein from the culture broth. The bacteria are genetically engineered to produce high levels of Ulinastatin, which is then extracted and purified using several chromatography techniques. The final product is tested for purity, potency, and safety before it is released for distribution.

  Quality Control:

  The production of Ulinastatin is subject to strict quality control measures to ensure that the final product meets the required standards. These measures include testing at every stage of the production process, from the cultivation of the bacteria to the final product. The product is also tested for its stability and shelf-life to ensure that it remains effective over time.


  Ulinastatin has been successfully developed as a drug for the treatment of inflammatory conditions. Its production process has been established to meet regulatory standards and ensure high-quality products. The pharmaceutical industry's interest in Ulinastatin manufacturing continues to grow, as it offers a promising solution for various inflammatory conditions. As the industry progresses, it will continue to refine the production process and quality control measures to ensure that Ulinastatin remains a safe and effective drug.