4
Drug developers aim to formulate new candidates that
remain stable through manufacturing, transport, and
storage so that patients don't receive altered products. In
fact, developers must demonstrate the long-term stability
of their protein products to regulatory authorities such as
the U.S. Food and Drug Administration to receive approval.
However, testing long-term protein stability in the laboratory
is time-consuming and can delay the development of a drug.
One way to address this challenge is to perform "forced
degradation" studies, a stress test that mimics the effects of
long-term storage on a protein's stability.
In addition, there is an ongoing need to establish predictive measures, such as a protein's unfolding transition
temperature, as an ongoing test to monitor stability of a drug candidate as it is being developed.
In short, protein stability is a critical measure for academic researchers as they explore the function of a target
molecule, and industry researchers as they screen and develop candidate molecules to be manufactured and delivered
to patients under the most stable and effective conditions.
APPLICATIONS
Characterizing protein stability is useful for:
• Screening
• Assay development
• Functional assay analysis
• Monitoring expression
• Purification
• Quality control
Understanding protein stability is key to gaining insights into the
function and regulatory roles of a molecule.
