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In storage conditions
we trust
Inappropriate storage conditions and exposure to extreme temperatures during
manufacturing have a detrimental effect on an antibody's structure. Scientists in
the pharmaceutical industry routinely test the stability of mAb a er they have been
stored at various temperatures for different lengths of time when developing new
mAb therapeutics. Forced degradation studies test the effects of severe storage
conditions on mAb; the assays test temperatures and chemical concentrations that
are more extreme than a mAb might come across during storage or manufacture.
Degradation testing is pivotal during biotherapeutics manufacturing; the assays
generate degradation products caused by antibody unfolding and aggregation
that can be studied to determine the stability of the molecule. Early stage stability
testing o en makes use of high-throughput assays, where a small number of
focused variables are measured, such as aggregation, purity, and unfolding.
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