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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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Detalles Bibliográficos
Autores principales:	Waldera-Lupa, Daniel M., Jasper, Yvonne, Köhne, Pia, Schwichtenhövel, Ronja, Falkenberg, Heiner, Flad, Thomas, Happersberger, Peter, Reisinger, Bernd, Dehghani, Alireza, Moussa, Roland, Waerner, Thomas
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Taylor & Francis 2021
Materias:	Report
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8344763/ https://www.ncbi.nlm.nih.gov/pubmed/34347561 http://dx.doi.org/10.1080/19420862.2021.1955432

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