title: Contamination of genetically engineered Chinese hamster ovary cells.
abstract: 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.
authors.affiliation: Alkermes, Inc., Cambridge MA, USA.
authors.forename: D G
authors.initials: DG
authors.lastname: Burstyn
mesh_terms: D000818:Animals; D001769:Blood / Q000821:virology; D001820:Bluetongue virus / Q000302:isolation & purification; D016466:CHO Cells / Q000821:virology*; D002417:Cattle / Q000097:blood / Q000196:embryology; D006224:Cricetinae; D003412:Cricetulus; D004340:Drug Contamination / Q000517:prevention & control; D005260:Female; D005818:Genetic Engineering; D018164:Hemorrhagic Disease Virus, Epizootic / Q000302:isolation & purification; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards