Host cell protein detection gap risk mitigation: quantitative IAC-MS for ELISA antibody reagent coverage determination

Host cell protein detection gap risk mitigation: quantitative IAC-MS for ELISA antibody reagent coverage determination

Host cell proteins (HCPs) must be sufficiently cleared from recombinant biopharmaceuticals during the downstream process (DSP) to ensure product quality, purity, and patient safety. For monitoring of HCP clearance, the typical method chosen is an enzyme-linked immunosorbent assay (ELISA) using polyc...

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Bibliographic Details
Main Authors: Daniel M. Waldera-Lupa, Yvonne Jasper, Pia Köhne, Ronja Schwichtenhövel, Heiner Falkenberg, Thomas Flad, Peter Happersberger, Bernd Reisinger, Alireza Dehghani, Roland Moussa, Thomas Waerner
Format: Journal Article
Language:English
Published: Taylor & Francis Group 2021-01-01
Series:mAbs
Subjects:
Host cell protein
mass spectrometry
proteomics
biopharmaceuticals
ELISA coverage
affinity purification
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2021.1955432
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https://www.tandfonline.com/doi/10.1080/19420862.2021.1955432

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