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Published in 2024 at "Molecular Pharmaceutics"
DOI: 10.1021/acs.molpharmaceut.4c01010
Abstract: Early-phase manufacturability assessment of high-concentration therapeutic monoclonal antibodies (mAbs) involves screening of process-related risks impacting their translation into the clinic. Manufacturing a mAb at scale relies on cost-effective and robust approaches to derisk manufacturability parameters,…
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Keywords:
manufacturability critical;
quality attribute;
assessing manufacturability;
manufacturability ... See more keywords