eBook: Analytical Method and QC Testing Strategies for Biologics Production - 27
Figure 3. Sensitivity assessment on the 7500 Fast instrument (top): In all the tests, NTC showed Ct = 40, and the LOD sample (30 fg) showed a
Ct value between 31-36. Results demonstrate a clean separation between LOD and NTC. Specificity assessment on the 7500 Fast instrument
(bottom): Both Sf9 and Baculovirus assays demonstrate high specificity in the presence of genomic DNA from other sources.
(5) Extraction efficiency of automated sample prep: Mock
matrices, mimicking different parts of the downstream
workflow, were generated to assess the extraction
efficiency of the KingFisher Flex automated sample
prep system. Different amounts of DNA were spiked
into each of these matrices, and percent recovery of the
spiked DNA was recorded. Results demonstrate efficient
recovery, between 75-100%, across all different matrices
tested from various parts of the workflow. (Figure 5)
(6) Inhibition control/IPC performance: To test inhibition
control, inhibitors such as Benzonase, Tween20, and
LV-MAX Medium were added to a sample, and DNA
extracted. The extract was run in the PCR assay to
determine whether the internal positive control (IPC)
was inhibited. If sample prep had not removed the
inhibitors, the PCR run would be inhibited and the
IPC signal suppressed. The data show that the IPC Ct
values for the inhibitor matrices were similar to the
values seen for the standards. This means that samples
were successfully prepared from a variety of matrices
containing inhibitors common to gene therapy
bioproduction workflows. (Figure 5)
27
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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