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Industry
Protein stability is an important parameter examined in every stage of the industry workflow, from beginning to end.
In the early stages of drug development, when researchers are screening many different candidates, researchers want
to predict the long-term stability of a protein as early as possible to ensure that lead candidates are developed into
effective and stable drugs. Therefore, researchers are interested in the conditions in which proteins aggregate, as
aggregation o en prevents normal protein function. The amount and size of aggregates that form is a critical factor to
determine whether or not a candidate moves forward into manufacturing.
An important stability parameter that impacts biologics development is the chemical stability of proteins, or their
resistance to chemical reactions between their amino acids and the surrounding environment. Deamidation or
oxidation are two types of chemical reactions that can influence the stability of proteins. Oxidation occurs in acidic
environments when the hydroxyl- groups on the amino acids tyrosine and serine release electrons and converts to an
oxygen group. Deamidation occurs when an amide group on the amino acids asparagine or glutamine is removed or
converted to another functional group. These processes can directly alter the amino acid composition of a biologic
(large or small protein molecules), thereby changing its physiological properties. These processes happen to proteins
over time, so researchers quantify it using functional analysis as well as techniques such as mass spectrometry, to
specifically examine the change to amino acids in the protein.
Understanding protein stability is key to gaining insights into the
function and regulatory roles of a molecule.
