eBook: Analytical Method and QC Testing Strategies for Biologics Production - 30

Figure 7. Sensitivity assessment on the QuantStudio 5 instrument (top): Results demonstrate a clean separation between LOD and NTC.
Specificity assessment on the QuantStudio 5 instrument (bottom): Both Sf9 and Baculovirus assays demonstrate high specificity in the
presence of genomic DNA from other sources.
matrix similar to the final drug formulation. The spikein
was done to mimic extraction of 100 pg, 10 pg, and
1 pg DNA from both of these matrices, as well as a
negative control. Results show efficient spike recovery
using PrepSEQ with both KingFisher Flex and manual
extraction. (Figure 9)
(6) Inhibition control/IPC performance: With QuantStudio
5, the IPC performs similarly to the standard curve, in
matrices containing inhibitors, such as Benzonase
and Tween20, showing that sample prep successfully
removes inhibitors from a variety of matrices that are
common in bioproduction workflows. (Figure 9)
Conclusion
The above case studies show clearly that the resDNASEQ
Quantitative Sf9 and Baculovirus DNA duplex assay kit
for residual DNA testing is a robust, comprehensive
solution with a rapid workflow and optimized sample
prep. It is a highly sensitive assay with a LOQ as low
30

eBook: Analytical Method and QC Testing Strategies for Biologics Production

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