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 e...
Topics
- Biotechnology
- Cell Line
- Child, Preschool
- Drug Contamination
- Factor VIII
- Hemophilia A
- Humans
- Male
- Mutation
- Prospective Studies
- Protein Engineering
- Recombinant Proteins