Include Specific Degradation Markers for Peptides and Proteins in Stability Studies
Understanding the Tip: Why degradation markers are crucial for biologic drug stability: Unlike small molecules, peptides and proteins are susceptible to a range of complex degradation pathways. Common mechanisms such as deamidation, oxidation, disulfide scrambling, and aggregation can lead to loss of activity, increased immunogenicity, or changes in pharmacokinetics. Generic physical or chemical tests may…
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