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Integration of rapid bioburden testing into production quality management systems and process control.
Ramos, Irina; Najera, Michelle; Schaefer, Gene.
Afiliación
  • Ramos I; AstraZeneca, Bioprocess Technologies & Engineering, Gaithersburg, Maryland, USA.
  • Najera M; Just-Evotec Biologics, Purification Process Design, Seattle, Washington, USA.
  • Schaefer G; National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Newark, Delaware, USA.
Biotechnol Prog ; 40(3): e3431, 2024.
Article en En | MEDLINE | ID: mdl-38450889
ABSTRACT
The move to integrated continuous bioprocessing (ICB), while providing a means for process intensification, can put added strain on process analytics when conventional methods are used. For instance, traditional microbial methods provide minimal value to ICB processes given that the time required for data to become available is much longer than a typical full cycle of the manufacturing process. Although rapid microbial detection has been in discussion for over 30 years, it is still not routinely deployed in commercial biopharmaceutical manufacturing. One contributing factor is the ability to integrate this technology into a process control strategy and existing quality systems. An understanding of the capability of microbial detection technology available today can be leveraged to implement a control strategy for bioburden monitoring in real time for process intermediates. One key tenet of this proposed control strategy is the use of a "two-tiered approach" wherein a fast (but possibly less sensitive) test is used to monitor the process and trigger further action for a second, longer duration test which is used to confirm and quantify the presence of bioburden and identify the organism. This approach, presented here alongside several case studies for microbial monitoring, can have broader application for other process analytical technologies where fit for purpose methods could be employed to establish process control alongside real time continuous processes.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Control de Calidad Idioma: En Revista: Biotechnol Prog Asunto de la revista: BIOTECNOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Control de Calidad Idioma: En Revista: Biotechnol Prog Asunto de la revista: BIOTECNOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos