Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline.
D000818:Animals; D001688:Biological Products / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D018929:Cell Culture Techniques / Q000592:standards*; D002460:Cell Line; D004274:DNA, Recombinant; D004340:Drug Contamination; D006801:Humans; D011487:Protein Conformation; D011506:Proteins; D011786:Quality Control; D014015:Tissue Banks / Q000592:standards
D001688:Biological Products; D004274:DNA, Recombinant; D011506:Proteins