EMA: Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products

Porcine trypsin is a common reagent used during the manufacture of biological medicinal products for the detachment of cells from the culture vessel for their passage. At manufacture of some vaccines, trypsin is added to the final culture stage at virus production for activation of the virus. In addition, for the manufacturing of specific recombinant proteins (e.g. insulin), trypsin is used as a reagent during the downstream process.