CASE STUDY 73683 Deploying the multi-attribute method (MAM) across sites at Pfizer Within Analytical R&D, there are three Project Progression Lines (PPL) who develop, qualify and implement informative, high quality methods for process support and product characterization/comparability throughout the lifecycle of each therapeutic molecule—from pre-clinical development to commercialization. They implement analytical techniques, including chromatographic and electrophoretic methodologies, and more recently they have expanded into mass spectrometry. In parallel, the Mass Spectrometry and Biophysical Characterization (MSBC) group has the mission of heightened characterization, which is to elucidate the molecular structure of biotherapeutics in an open, collaborative, and timely ma

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