The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
News|Articles|June 24, 2026
Addressing False Positives in Sequence Variant Analysis
Author(s)Catalent
Sequence variant analysis is essential for characterizing biotherapeutic proteins, but high rates of false positives can slow development. Subtle yet potentially profound changes to a protein's amino acid sequence can dramatically alter its function and impact patient safety. This paper reveals how low-level posttranslational modifications introduced during protein digestion can be misidentified as sequence variants. By implementing time-course digestion during method development, it can effectively distinguish true variants from artifacts, significantly reducing data analysis time. Case studies also show how to integrate time-course digestion into a workflow.
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