Defining Golden Batches in Biomanufacturing Processes From Internal Metabolic Activity to Detect Process Changes That May Affect Product Quality

Cellular metabolism plays a role in the observed variability of a drug substance's Critical Quality Attributes (CQAs) made by biomanufacturing processes. Therefore, here we describe a new approach for monitoring biomanufacturing processes that measures a set of metabolic reaction rates (named C...

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Veröffentlicht in:	Biotechnology and bioengineering 2024-10
Hauptverfasser:	Bush, Xin, Fratz-Berilla, Erica J, Kohnhorst, Casey L, King, Roberta, Agarabi, Cyrus, Powers, David N, Trunfio, Nicholas
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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