Burstyn D G
Alkermes, Inc., Cambridge MA, USA.
Dev Biol Stand. 1996;88:199-203.
In late 1988, during production of a recombinant protein for phase I clinical trials, a failure of the cell culture production system occurred due to contamination of the cells by an orbivirus [1]. The incident occurred at Bioferon GmbH & Co, Laupheim, Germany, a joint venture of Biogen, Inc., Cambridge, MA, and Dr. Renstschler Arzneimittel GmbH & Co (Bioferon is currently a wholly owned subsidiary of Rentschler and is now known as Dr. Rentschler Biotechnologie GmbH). The investigation into, and the subsequent response to, the infection can be divided into three stages: Stage I, Investigation and initial response; Stage II, Secondary response; and Stage III: Continuing response.
1988年末，在生产用于I期临床试验的重组蛋白过程中，由于细胞被环状病毒污染，细胞培养生产系统出现故障[1]。该事件发生在德国劳普海姆的Bioferon GmbH & Co公司，它是马萨诸塞州剑桥市的百健公司与Renstschler Arzneimittel博士有限公司的合资企业（Bioferon目前是Rentschler的全资子公司，现称为Rentschler博士生物技术有限公司）。对此次感染的调查及后续应对可分为三个阶段：第一阶段，调查与初步应对；第二阶段，二次应对；第三阶段：持续应对。
