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

Journal of Biotechnology
Ozan ÖtesFlorian Capito

Abstract

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 Cadence™ BioSMB PD and the Cadence™ 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.

Citations

Nov 28, 2019·Expert Opinion on Biological Therapy·Mafalda G MoleirinhoCristina Peixoto
Jan 11, 2020·Frontiers in Bioengineering and Biotechnology·Nagesh K Tripathi, Ambuj Shrivastava
Apr 26, 2020·Biotechnology Journal·Ana Cecília Afonso RoqueMarcel Ottens
Dec 12, 2019·Frontiers in Bioengineering and Biotechnology·Julian KoppChristoph Herwig
Dec 15, 2020·Journal of Toxicology and Environmental Health. Part B, Critical Reviews·Lucilene SantosRui Seabra Ferreira
Jan 15, 2021·Journal of Chromatography. a·Dong-Qiang LinShan-Jing Yao
Apr 13, 2021·MAbs·Ohnmar Khanal, Abraham M Lenhoff

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