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Formulation
The goal of the formulation process is to find safe,
efficient, and convenient storage media for a biologic
that can be used downstream for assays, therapeutics,
or bioengineered processes. This work involves
monitoring how a protein behaves long term. Unlike
small molecule therapeutics, biologics are much
larger and have more complex structures. They are
very sensitive to their environment and can easily
aggregate or denature. DLS can detect the unfolding
of a protein or the existence of several protein species,
which are important indications that your formulation
needs work. Changes in buffer salt concentration, pH,
temperature, or protein concentration can all affect
protein stability.
Antibody Engineering
Artificial intelligence (AI)-based design of Ab-
based therapeutics or diagnostic markers is of
increasing interest for understanding how certain
mutations affect stability parameters. However,
computational approaches are as yet unable to
reliably predict these effects. DLS can measure
how mutations alter the size and propensity
to aggregate in engineered antibodies. Ab
researchers want to know the Abs developed from
screening libraries will be stable, and thus more
likely to be successful as therapeutics.
