Trypsin. Properties and Use in the Production of Biological Medicinal Products
The production of biological medicinal products used for prophylactic, diagnostic and therapeutic purposes includes the use of inherently  variable biological processes and materials. In order to ensure the  quality of the finished biological product it is necessary to determine  the source, nature and fitness for use of the starting materials, including reagents, culture media, buffer solutions, sera,  and enzymes. The article summarises literature data on the  structure, properties and mode of action of the animal-derived  reagent trypsin — proteolytic enzyme widely used in the production  of biological medicinal products. The article dwells upon the sources  of trypsin, methods of its production, requirements for trypsin  products of different purity grades intended for human and  veterinary use as well as for use as reagents in the production of  vaccines, advanced therapy medicinal products and genetically engineered products. The article describes the role that  trypsin plays in the human and animal intestinal digestive enzyme  systems, in dissociation of cells in cultures in the process of cell  passaging, in the mechanism of proteolitic activation and inactivation of a wide range of viruses, and in the examination of proteins  primary structure.