Gene Stability in Mammalian Cells and Protein Consistency

摘要: The safety of a patient who is the recipient protein drugs has to be assured. A "wrong" thought represent great risk. philosophy testing strategies related gene stability with product will discussed in light experimental data available today. Although all mammalian cell lines used production biologicals including recombinant DNA-derived have been produced from individual clones (functional monoclonality) they found heterogenous regard genomic content (number chromosomes, characteristics identifiable chromosomes and position number integrated sequences). verification presence correct line constitutes well accepted useful test, especially if derived by "population sequencing". batch not repeated confirmation this fact cannot lead any additional assurance for correctness proteins constituting given beyond level provided cheminal testing. In contrast obvious unavoidable heterogeneity cellular genomes, coding regions genes shown change. Evidence demonstrate consistency products originating (and hybridoma) lines, e.g. more than 500,000 patients received tolerated rtPA well.