Production Cell Substrates and vCJD

摘要

The outbreak of bovine spongiform encephalopathy in the United Kingdom caused great concern about the safety of materials derived from cows. While the primary issues were to do with food, biological medicinal products where manufacture involved ingredients such as calf serum were also subjected to scrutiny. In 1996 a new form of Creutzfeld Jakob Disease (vCJD) was identified in the U.K. in young people and linked to exposure to BSE [1-3]. As human blood and blood products such as clotting factors from U.K. sources incubating the disease could be contaminated with the infectious agent, the U.K. government stopped the fractionation of U.K.-sourced plasma for the manufacture of blood products. This caused difficulties world-wide as varying exclusions were introduced in other countries for individuals who had spent some time in the U.K. during the period of highest risk.