Illuminating a biologics development challenge: systematic characterization of CHO cell-derived hydrolases identified in monoclonal antibody formulations

Illuminating a biologics development challenge: systematic characterization of CHO cell-derived hydrolases identified in monoclonal antibody formulations

Monoclonal antibodies (mAb) and other biological drugs are affected by enzymatic polysorbate (PS) degradation that reduces product stability and jeopardizes the supply of innovative medicines. PS represents a critical surfactant stabilizing the active pharmaceutical ingredients, which are produced b...

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Bibliographic Details
Main Authors: Melanie Maier, Linus Weiß, Nikolas Zeh, Valerie Schmieder-Todtenhaupt, Alireza Dehghani, Marius Nicolaus Felix, Daniel Heinzelmann, Benjamin Lindner, Moritz Schmidt, Joey Studts, Patrick Schulz, Bernd Reisinger, Kerstin Otte, Matthias Franzreb, Daniel Lakatos, Simon Fischer
Format: Article
Language:English
Published: Taylor & Francis Group 2024-12-01
Series:mAbs
Subjects:
Polysorbate
hydrolase
hydrolysis
degradation
host cell protein
lipase
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2024.2375798
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