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Thermal denaturation is not a required aspect of
DLS evaluation, but the ability to measure these
additional parameters enables you to make
better decisions about your candidates. When
optimizing candidates, having more information
gives you a better picture of how your biologics
are behaving, which offers the potential for
greater success long-term. The result of
the combined measurements is a multi-
parameter output that gives researchers
more information about their samples with
the same amount of material consumption.
Long-term storage stability
Since it is impractical for researchers to spend years
monitoring stability conditions before delivering a therapeutic
to market, it is important to understand how a biologic
is likely to behave long-term. Accelerated stress studies
monitor how the PDI and r
H
change over time for prolonged
treatment. To address this, use DLS to do an isothermal QC
assessment over a period of several weeks. The changes
observed over this time frame are used to extrapolate how
these formulations will behave long-term in storage.
Full stability assessment matrix
It is worth noting that for biologics researchers, there are
a vast array of assays that are used to assess the stability,
quality, and ultimate likelihood of success for their
candidates. No single instrument or technique tells you
everything you need to know about your candidate. However,
DLS and thermal denaturation are relatively straightforward
methods that use low sample volumes, making them a
valuable first step in the formulation process.
