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Experimental
variables
When it's used What to look for in your DLS
data
Mutational analysis Improving binding affinity or overall
stability of a candidate
Do certain site mutations lower PDI?
How do PDI and r
H
compare to the
parent compound?
Concentration
In self-association experiments (see
Section 4) or to monitor stability of
a candidate at its storage/shipping/
functional concentration
Is the k
D
negative? This can be
indicative of self-association and
potential for aggregation.
Does the PDI change when you
change the concentration, and how
will that ultimately affect delivery?
Conjugation ADCs for targeted drug delivery;
PEGylation for long-term stability in
blood circulation
Does the conjugation reaction affect
the stability of the mAb? Are there
additional peaks from unconjugated
compounds?
Other proteins Multi-Ab platforms; stabilizing
proteins such as BSA
Does the presence of additional
protein affect k
d
/self-association? Are
profile changes due to the biologic
candidate or the additive?
Buffer formulation Storage/assay/delivery
environment all crucial for stability
of the ultimate drug
See Table 2
What affects formulation?
