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Can I read Scale-up of continuous multicolumn chromatography for the protein a capture step: From bench to clinical manufacturing on EtoBox?

Scale-up of continuous multicolumn chromatography for the protein a capture step: From bench to clinical manufacturing by Ozan Ötes; Hendrik Flato; Daniel Vazquez Ramirez; Britta Badertscher; Marc Bisschops; Florian Capito is a Biochemistry, Genetics and Molecular Biology article available to read on EtoBox.

What is Scale-up of continuous multicolumn chromatography for the protein a capture step: From bench to clinical manufacturing about?

The awareness about implementing continuous processing for biopharmaceutical products has significantly increased throughout the recent years not only at developmental scale but also for phase I supply in clinical trial manufacturing. In this study, we focused on upscaling continuous protein A chromatography from lab to pilot scale using the CadenceTM BioSMB PD and the CadenceTM BioSMB Process 80 system, respectively. Additionally, we evaluated hardware and software capability whilst running the system for 10 days non-stop using feed from a perfusion bioreactor. In terms of product quality and removal of impurities, comparable data was obtained regarding lab scale and production scale. Compared to batch mode, productivity was increased by 400 to 500%. Furthermore, the system worked accurately during the whole trial, proving its potential for the implementation into a hybrid or an end-to-end continuous process.

Who reads Scale-up of continuous multicolumn chromatography for the protein a capture step: From bench to clinical manufacturing?

It is typically read by researchers, students, and practitioners in Biochemistry, Genetics and Molecular Biology.

Author
Ozan Ötes; Hendrik Flato; Daniel Vazquez Ramirez; Britta Badertscher; Marc Bisschops; Florian Capito
Published
2018
Language
EN
Field
Biochemistry, Genetics and Molecular Biology (Life Sciences)

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