Výsledky vyhledávání - "Donald E. Walker"

Detection of Residual Host Cell Proteins in Biotherapeutic Drugs by Concatenated 2D LC-MS/MS

Autor: Delia Li, Feng Yang, Donald E. Walker

Publikováno v: Therapeutic Antibodies ISBN: 9781071614495

A sensitive and reliable two-dimensional LC-MS/MS method is described, which detects low level (≥10 ppm) host cell proteins (HCPs) in monoclonal antibody (mAb) drug products. This method applies a high pH-low pH two-dimensional reversed phase (RP)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::682d21ed08e0d7891102c71b6db9ea22
https://doi.org/10.1007/978-1-0716-1450-1_16

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Fast, Robust, and Sensitive Identification of Residual Host Cell Proteins in Recombinant Monoclonal Antibodies Using Sodium Deoxycholate Assisted Digestion

Autor: David A. Michels, Donald E. Walker, Qing Zhu, Feng Yang, Adam Farchone, Frank Macchi, Delia Li

Publikováno v: Analytical chemistry. 92(17)

Residual host cell proteins (HCPs) present in biotherapeutics can pose potential safety risks for patients or affect product stability, thus prompting a critical need to monitor HCPs in drug substance or product to ensure product safety and quality.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d4f6279378b69451d0e682dd807ff24
https://pubmed.ncbi.nlm.nih.gov/32786500

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A 2D LC-MS/MS Strategy for Reliable Detection of 10-ppm Level Residual Host Cell Proteins in Therapeutic Antibodies

Autor: David A. Michels, Alice Zhang, John T. Stults, Reed J. Harris, Donald E. Walker, Joseph Carver, Feng Yang, Jeannine Schoenfelder, Delia Li, X. Christopher Yu

Publikováno v: Analytical Chemistry. 90:13365-13372

Methodologies employing LC-MS/MS have been increasingly used for characterization and identification of residual host cell proteins (HCPs) in biopharmaceutical products to ensure their consistent product quality and safety for patients. To improve th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7357a22c743a89302c706a5ceca5e4a5
https://doi.org/10.1021/acs.analchem.8b03044

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A modular and adaptive mass spectrometry-based platform for support of bioprocess development toward optimal host cell protein clearance

Autor: Feng Yang, David A. Michels, X. Christopher Yu, Koman Joe, Donald E. Walker, Joseph Carver

Publikováno v: mAbs. 9:654-663

A modular and adaptive mass spectrometry (MS)-based platform was developed to provide fast, robust and sensitive host cell protein (HCP) analytics to support process development. This platform relies on one-dimensional ultra-high performance liquid c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0737affc0e122601c02fa831dc2217f1
https://doi.org/10.1080/19420862.2017.1303023

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Autor: Feny Gunawan, Julie C. Nishihara, Donald E. Walker, X. Christopher Yu, Eric Huang, Martin Vanderlaan, Denise C. Krawitz, Judith Zhu-Shimoni, Inn H. Yuk, Pynn Abigail Friederike Joyce, Jayashree Subramanian

Publikováno v: Biotechnology and Bioengineering. 112:2068-2083

To understand the diversity in the cell culture harvest (i.e., feedstock) provided for downstream processing, we compared host cell protein (HCP) profiles using three Chinese Hamster Ovary (CHO) cell lines in null runs which did not generate any reco

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::91a82618b1a5ff3aeacb15cc59cd307b
https://doi.org/10.1002/bit.25615

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