Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
|Articles|December 5, 2022
Multi-Attribute Methods for Biopharmaceutical Analysis
Author(s)Waters
Obtain more data without the ambiguity of traditional chromatographic and electrophoretic assays. This notebook compiles app notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.
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