Characterization of Critical Quality Attributes of an Anti-PCSK9 Monoclonal Antibody

During early development of biopharmaceuticals, suboptimal producing clones and production conditions can result in limited quantities of high-purity products. Here we describe a systematic approach, which requires minimal amounts of protein (~10 mg) to assess critical quality attributes of a monocl...

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Bibliographic Details

Published in:	Biologics
Main Authors:	Thayana A. Cruz, Nicholas R. Larson, Yangjie Wei, Natalia Subelzu, Yaqi Wu, Christian Schöneich, Leda R. Castilho, Charles Russell Middaugh
Format:	Article
Language:	English
Published:	MDPI AG 2024-09-01
Subjects:	anti-PCSK9 monoclonal antibody evolocumab Repatha mAb characterization critical quality attributes (CQAs)
Online Access:	https://www.mdpi.com/2673-8449/4/3/19