Integrated SegFlow, µSIA, and UPLC for Online Sialic Acid Quantitation of Glycoproteins Directly from Bioreactors

ABSTRACT This study emphasizes the critical importance of closely monitoring and controlling the sialic acid content in therapeutic glycoproteins, including EPO, interferon‐γ, Orencia, Enbrel, and others, as the level of sialylation directly impacts their pharmacokinetics (PK), immunogenicity, poten...

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Hlavní autoři:	Letha Chemmalil, Tanmay Kulkarni, Mathura Raman, Priya Singh, Yueming Qian, Chris Chumsae, Kyle McHugh, Zhuangrong Huang, Eric Hodgman, Michael C. Borys, Julia Ding, Gloria Li, Anthony Leone
Médium:	Artigo
Jazyk:	Inglês
Vydáno:	Maximum Academic Press 2025-01-01
Edice:	Engineering in Life Sciences
Témata:	µSIA continuous bioprocessing FIA labs monoclonal antibody (mAb) process analytical technology (PAT) quality by design (QbD)
On-line přístup:	https://doi.org/10.1002/elsc.202400031
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