Свиной трипсин - это реагент, используемый для производства нескольких лекарственных препаратов. Он извлекается из поджелудочной железы свиней, из-за чего существует риск заражения посторонними агентами. Свиной трипсин может производиться в виде порошка или жидкого раствора в зависимости от области применения.
Some applications like protein chemistry require a highly refined version of porcine trypsin to be used. Trypsin used in cell culture may contain impurities from the starting material, but these generally do not affect the performance of cell culture. The current article provides insights into the key applications and precautions while using recombinant porcine trypsin.
Porcine trypsin is widely used as a reagent for the manufacturing of vaccines, advanced therapy medicinal products, or other medicinal products made from cell culture. It is also used to activate virus particles and as a protein processing reagent.
How is Recombinant Porcine Manufactured
Porcine trypsin is extracted from the pancreatic glands of pigs. It is purified by optional purification processes like precipitation and chromatography. The manufacturing process involves incubation at low pH.
Commercially available trypsin retains its activity after prolonged treatment at a pH of 1 at 4-degrees Celsius.
In some cases, a final pathogen inactivation step like gamma radiation, e-beam radiation, or UV radiation is also applied. Gamma radiation is usually applied to frozen liquid trypsin. Applying radiation to the lyophilized powder needs a careful examination of virus inactivation.
Precautions for Using
Trypsin is derived from animal extracts and it can be contaminated with numerous biological agents. It should be thoroughly tested and treated for inactivation and removal of such dangerous contaminants. Once these impurities have been removed only, it should be used for making medicinal products.
Testing of pooled material should be performed before any virus inactivation has been done. The stage in which the testing is to be done should be clearly defined and justified.
Porcine trypsin to be used as a reagent for cell culture or activation of virus particles should strictly comply with the test of sterility. It should also be free of any mycoplasmas. For other applications, it should comply with the tests needed in Ph. Eur 0694 or any other equivalent tests.
The medicinal product using trypsin should have enough information disclosure to allow a thorough risk assessment by the authorities. Disclosures like the testing method, stage at which virus testing is done, volumes and sensitivity of the virus test, etc. should be made.