eBook: Analytical Method and QC Testing Strategies for Biologics Production - 28

Case study on QuantStudio 5:
(1) Precision, efficiency, and linearity: The QuantStudio
5 standard curve performance was similar to the
7500 Fast. The quantitation range standard curve
displayed PCR efficiency values very close to 100%
(within ± 10%), R2
values greater than 0.99, and high
Figure 4. Singleplex vs multiplex performance on the 7500 Fast
instrument: The standard curves to overlap indicating the Sf9
and baculovirus assays do not interfere with each other.
linearity (slope: -3.1 to -3.6). A total of 17 plates were
run in two different sites (US and Singapore), and
data collected by seven users over four days on five
different QuantStudio 5 instruments. No significant
difference was found across all points on the standard
curve and high overall precision was achieved down
to an LOQ of 0.3 pg, indicating that the data are
consistent and reliable across multiple sites, operators,
and instruments. (Figure 6)
Figure 5. Extraction efficiency measurement on the 7500 Fast instrument (top): KingFisher Flex sample extraction %recovery is efficient
across several matrices in the bioproduction workflow. Testing inhibition control on the 7500 Fast instrument (bottom): IPC Ct values
obtained show that samples were successfully prepared from a variety of matrices containing inhibitors.
28

eBook: Analytical Method and QC Testing Strategies for Biologics Production

Table of Contents for the Digital Edition of eBook: Analytical Method and QC Testing Strategies for Biologics Production

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