Peptide Mapping | Quality Assistance

Peptide mapping is a key analytical method for characterising therapeutic proteins, and is one of the analytical techniques required by ICH guidance Q6B. It provides a significant amount of data from primary sequence to post-translational modifications. The study sheet describes several techniques, including (U)HPLC/UV, MS and high‑resolution LC‑MS. It also presents the use of Multi‑Attribute Monitoring (MAM) for simultaneous identification and quantification of multiple product quality attributes in a GMP environment.

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