Prozess Analytische Technologie in der Biotechnologie

Biotechnologische Prozesse sind durch eine enorme Komplexitat von intrazellularen Wechselwirkungen charakterisiert. Prozess Analytische Technologie (PAT) soll nach Vorgabe von den Regulationsbehorden eingesetzt werden, um diese Prozesse wissenschaftlich basiert und robust zu entwickeln. Der Beitrag zeigt die Entwicklungen von PAT-Sensoren fur die Echtzeitmessung und die Notwendigkeit der Integration von PAT-gerechten Daten in Quality by Design (QbD) durch Datenauswertung auf. PAT ist quantitativ und sollte als ein Werkzeug innerhalb von QbD verstanden werden, was auser der Echtzeitmessung auch den Weg mittels Datenauswertung zu kritischen Prozessparametern erlaubt. PAT ist daher nicht zwingend mit dem Kauf teurer Online-Analytik gleichzusetzen. Die Kombination von Sensoren und Auswertemethoden sichert die Durchgangigkeit von der Prozessentwicklung in die industrielle Herstellung und wird die Wissenschaftlichkeit als essentiellen Bestandteil in der Bioprozessentwicklung verankern.

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