Industry Information

Ulinastatin Manufacture

  Ulinastatin is a protein drug that is derived from human urine or other animal sources, such as pigs or cows. It is a type of protease inhibitor that is used for the treatment of inflammatory conditions and shock.

  The manufacture of ulinastatin involves several steps, including protein purification and formulation. The following is a brief overview of the manufacturing process:

  Collection of raw materials: The starting material for ulinastatin manufacture is collected from either human urine or animal sources.

  Purification: The raw material is purified using various methods such as fractionation, chromatography, and ultrafiltration to obtain the desired protein.

Ulinastatin Manufacture

  Formulation: The purified protein is then formulated with excipients and stabilizers to create a stable drug product.

  Quality control: The drug product is subjected to rigorous quality control testing to ensure its purity, potency, and safety.

  Packaging: The drug product is then packaged in sterile vials or cartridges for distribution to hospitals and clinics.

  Ulinastatin has been widely used in Japan and China for the treatment of various conditions, such as acute pancreatitis, sepsis, and trauma. It has also shown potential in the treatment of COVID-19 patients with severe respiratory distress syndrome.

  In conclusion, ulinastatin manufacture is a complex process that involves several steps of protein purification and formulation. The resulting drug product is subject to rigorous quality control testing to ensure its safety and efficacy. The use of ulinastatin has shown promise in the treatment of various inflammatory conditions and continues to be an area of active research.