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Cell Metabolism, Volume 27, Issue 4, 740 756
Hassan A, Tsuda Y, Asai A, Yokohama K, Nakamura K, Sujishi T, et al
Topics include structural and functional equivalence demonstration, comprehensive analytical characterization strategies (including higher-order structure analysis and mass spectrometry), peptide-specific stability challenges and shelf-life determinations, impurity profiling and characterization, and an update on peptide impurity qualification
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