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Good DLS sample prep is essential to get meaningful and
reproducible results. Depending on where you are in the biologics
development workflow, the way you prepare your sample will
vary. This is because the goals at the different stages are not the
same. If you are not yet concerned with the long-term formation
of large aggregates or the presence of certain purification by-
products, it is appropriate to remove these prior to running the
experiment. On the other hand, if you are concerned with whether
there has been accumulation of large particles or aggregates over
time or as a result of a given treatment – which may be the case if
you are working on formulation or scaling of production – it may
serve you better not to do such treatments.
When considering long-term storage behavior, designing an
accelerated stress study can help predict the propensity of your
candidate to form aggregates or become destabilized during
storage or shipment. We discussed these experiments in Section
4. For the development of therapeutic mAbs, it is critical not only
to understand whether aggregation is present, but also to know
when and how it forms and the ultimate size of these aggregates,
in order to prevent adverse reactions in the clinic.
Know the purpose of your experiment
