Industry Information

Ulinastatin Manufacture: A Production Overview

  Ulinastatin is a naturally occurring protease inhibitor that has been used to treat various medical conditions, such as acute pancreatitis, sepsis, and acute respiratory distress syndrome. Here is an overview of the manufacturing process of ulinastatin:


  The first step in the manufacture of ulinastatin is the fermentation of a selected strain of bacteria, usually Bacillus subtilis or Escherichia coli. The bacteria are cultured in a nutrient-rich medium under controlled conditions, including temperature, pH, and aeration. The fermentation process can last from several hours to several days depending on the specific strain of bacteria used.

Ulinastatin Manufacture: A Production Overview


  Once the bacteria have grown, they are harvested and separated from the fermentation broth using centrifugation or filtration. The resulting cell pellet is then washed with buffer solution to remove any extraneous proteins and other unwanted materials.


  The cell pellet is then subject to several rounds of extraction, usually with alkaline solution, to release the ulinastatin protein. The extracted protein is then purified using techniques such as column chromatography, ultrafiltration, and diafiltration to remove impurities.


  After purification, the ulinastatin protein is formulated into its final dosage form, usually as a lyophilized powder or solution. Excipients such as mannitol, lactose, or glycine may be added to stabilize the protein and improve its solubility.

  Quality control

  Throughout the manufacturing process, strict quality control measures are implemented to ensure the final product meets the required specifications for potency, purity, and safety. Quality control tests may include assays for protein concentration, purity, and activity, as well as tests for sterility, endotoxins, and other impurities.

  In conclusion, the manufacture of ulinastatin involves several complex steps, including fermentation, harvesting, extraction, formulation, and quality control. The final product must meet strict regulatory requirements before it is considered safe and effective for use in patients.