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Figure 6: Bioanalytical tests for the parameters of endogenous contamination with HCPs and nucleic acids. Advantages (in green), disadvantages (in red) and “neutral” criteria on the basis of the criteria for target qualification are given for protein dot-blotting and quantitative polymerase chain reaction as exemplified for some insulin variants, which were produced in recombinant yeast cells (symbols see Figure 1), and extract from non-transfected yeast and 5.8S-RNA standard, respectively. Some alternative methods are listed at the bottom. |