Waters, Genovis team up on automated CQA characterization

By The Science Advisory Board staff writers

Waters and Genovis are working together to develop and market routine biopharmaceutical characterization workflows of critical quality attributes (CQAs) of monoclonal antibodies (mAbs).

The goal is to develop automated workflows for the rapid and consistent characterization of CQAs of mAbs and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control, according to the companies. The companies will combine Genovis' SmartEnzymes with automation, chromatography/time-of-flight mass spectrometry (MS), and application-specific software workflows from Waters, including its BioAccord liquid chromatography (LC)-MS system and Andrew+ pipefitting robot.

The workflows being developed will focus on three application areas: product variant analysis (e.g., glycosylation, oxidation), bioprocess stability monitoring, and biosimilar glycosylation analysis, the companies said.

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