title: Strategies to avoid virus transmissions by biopharmaceutic products.
abstract: The use of biopharmaceutical products offers an opportunity for the treatment of many diseases. Biotechnical manufacturing using recombinant mammalian cell lines is the most appropriate method today for the production of biopharmaceutical protein drugs for the treatment of human and animal diseases. However, mammalian cell line derived products have a potential risk for virus transmission to patients who are treated with these biopharmaceutical products. The reliability that biological products are free of any viruses requires a combination of several strategies: The use of well-characterized cell bank systems and, if feasible, the avoidance of biological raw materials for the cultivation of these mammalian cell lines and the production of biopharmaceuticals. Further on, the purification process for biopharmaceuticals has to be validated for its ability to efficiently remove and inactivate any potential virus contamination and, where applicable, also unconventional transmissible agents, such as BSE. In addition, the biopharmaceutical product itself can be tested for the presence of viruses. Like other manufacturing processes, biotechnical production processes have to be performed in compliance with current Good Manufacturing Practices (cGMP).
authors.affiliation: Dr. Karl Thomae GmbH, Boehringer Ingelheim, Department of Biotech Production, Biberach/Riss, Federal Republic of Germany.
authors.forename: W
authors.initials: W
authors.lastname: Werz
authors.forename: H
authors.initials: H
authors.lastname: Hoffmann
authors.forename: K
authors.initials: K
authors.lastname: Haberer
authors.forename: J K
authors.initials: JK
authors.lastname: Walter
mesh_terms: D000818:Animals; D002417:Cattle; D002460:Cell Line; D003257:Consumer Product Safety; D006224:Cricetinae; D004340:Drug Contamination / Q000517:prevention & control*; D016643:Encephalopathy, Bovine Spongiform / Q000517:prevention & control / Q000635:transmission / Q000821:virology; D005260:Female; D006361:Heating; D006801:Humans; D008647:Mesocricetus; D004364:Pharmaceutical Preparations / Q000592:standards; D011786:Quality Control; D018570:Risk Assessment; D014777:Virus Diseases / Q000517:prevention & control* / Q000635:transmission*
chemical_list: D004364:Pharmaceutical Preparations