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Description

Alemtuzumab is US Food and Drug Administration (FDA)-approved for the treatment of B cell chronic lymphocytic leukaemia (B-CLL) [19] and multiple sclerosis [20] and is being explored as a lymphodepleting agent in conditioning regimens, primarily to reduce the incidence of GvHD

The relevant analytical framework follows the ICH Q6B guidance for peptide drug substances, which covers reporting of identity, purity, content, and impurity profiles