eBook: Analytical Method and QC Testing Strategies for Biologics Production - 15

this test is because it represents a sample near the end
of a purification where, typically, the specification of
acceptable levels of host cell DNA would be applied.
Acceptance criteria: DNA recovery at LOQ must be
between 50-150%.
Results: The samples met the acceptance criteria -
percent recovery was between 50-150% for the six
samples evaluated.
Precision Assessment
The precision of an analytical procedure expresses the
closeness of agreement, or degree of scatter, between
a series of measurements obtained from multiple
sampling of the same homogeneous solution under
the prescribed conditions. Precision maybe considered
at three levels: repeatability, intermediate precision,
and reproducibility.
Why this is necessary: To ensure precision under the same
operating conditions over time (repeatability or intra-assay
precision), and to ensure precision under laboratory
variations, including over different days, different equipment,
different analysis (intermediate precision).
Study design:
Part 1 - Six replicates of the surrogate bulk drug
substance were spiked with 10 pg DNA/test sample
and tested.
Part 2 - Two analysts ran the same assay in Part 1, twice
(3 samples), on different days.
Acceptance criteria: For Part 1, %CV must be less than
25% for all samples tested. For Part 2, the mean %CV
for the average amount of DNA measured in the 15
test samples must be less than 25%.
Results: The %CV and the mean %CV were both below
the acceptance criteria of 25%.
To learn more about the resDNASEQ system, please
visit: thermofisher.com/resdnaseq
References
1. Apostal, I., Kelner, D.N. " Managing the Analytical Lifecycle
for Biotechnology Products - Part One. " BioProcess Int, Sept.
2008. https://bioprocessintl.com/analytical/downstreamvalidation/managing-the-analytical-lifecycle-for-biotechnologyproducts-183144/
2.
Apostal, I., Kelner, D.N. " Managing the Analytical Lifecycle for
Biotechnology Products - Part Two. " BioProcess Int, Oct. 2008.
https://bioprocessintl.com/analytical/downstream-validation/
managing-the-analytical-life-cycle-for-biotechnologyproducts-183234/
Conclusion
Method
validation of analytical methods that are
used to test quality and safety of licensed products
is a regulatory requirement. Residual host-cell DNA
impurities, measured in the final dosage form, must
follow regulatory guidelines established by agencies
such as the US FDA, European Medicines Agency
(EMA), the World Health Organization (WHO), and other
regional regulatory jurisdictions. As the case study
above demonstrates,
resDNASEQ assays combined
with PrepSEQ sample prep, perform in a manner that
enables meeting or exceeding these expectations.
" The complete resDNASEQ solution includes all
components required for quantitation of host cell DNA,
from the sample prep to the quantitation method,
instrumentation, the application specific software that
enables compliance with CFR 21 Part 11 guidance, and
even technical support - meaning a field application
scientist can come to your lab and train people on how
to run the assay and how to get valid results with it, "
mentions Brewer. " It is really an end-to-end solution. "
15

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eBook: Analytical Method and QC Testing Strategies for Biologics Production

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