Robinson M M
USDA-ARS Animal Disease Research Unit, Washington State University, Pullman, USA.
Dev Biol Stand. 1996;88:237-41.
The use of post-mortem tissues as sources for the production of biologicals, vaccines and feedstuffs has led to the transmission or generation of transmissible encephalopathies in some recipients. For example, the use of pituitary-derived human growth hormone and gonadotropins has resulted in the transmission of Creutzfeldt-Jakob disease to other humans [1], the use of formalin-inactivated sheep brain as a source for louping ill vaccine led to the transmission of scrapie to over 1,000 sheep from one vaccine lot [2], and the use of rendered products from ruminant carcasses in the domestic animal food chain led to the emergence and epizootic of bovine spongifrom encephalopathy in the United Kingdom [3]. Infection with transmissible encephalopathies by iatrogenic or other mechanisms is difficult to predict or control. The characteristics of these pathogens do not permit easy detection, clearance, or inactivation in routine biopharmaceutical production environments.
将尸检组织用作生产生物制品、疫苗和饲料的来源，已导致在一些接受者中传播或产生可传播性脑病。例如，使用垂体来源的人生长激素和促性腺激素已导致克雅氏病传播给其他人类[1]，使用甲醛灭活的羊脑作为跳跃病疫苗的来源导致一批疫苗将羊瘙痒病传播给1000多只绵羊[2]，以及在家畜食物链中使用反刍动物尸体的加工产品导致英国出现牛海绵状脑病并暴发流行[3]。通过医源性或其他机制感染可传播性脑病很难预测或控制。这些病原体的特性使得在常规生物制药生产环境中难以轻松检测、清除或灭活。
