Article
A clinical evaluation of genetic stability.
Developments in biological standardization - 1 Jan 1994
Gomperts E D, Courter S G, Lynes M D, Baker D A
Abstract excerpt
Mutation in a genetically engineered cell line has not been shown to have been responsible for adverse clinical reactions in a currently licensed biotechnology product. There exists, however, the theoretical possibility that mutations in the production cell line could ultimately lead to patient exposure to aberrant proteins which could result in unanticipated or deleterious effects. The clinical trials of...
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