Articles with "assessing manufacturability" as a keyword



Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants

Sign Up to like & get
recommendations!
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,… read more here.

Keywords: manufacturability critical; quality attribute; assessing manufacturability; manufacturability ... See more keywords