Scalability of Sartobind® Rapid A Membrane for High Productivity Monoclonal Antibody Capture

Autor: Sabrina Yang, Ryszard Braczkowski, Shih-Hsun Chen, Ricarda Busse, Yudhi Li, Louis Fabri, Innocent Berbelle Bekard
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Membranes, Vol 13, Iss 10, p 815 (2023)
Druh dokumentu: article
ISSN: 13100815
2077-0375
DOI: 10.3390/membranes13100815
Popis: Improved upstream titres in therapeutic monoclonal antibody (mAb) production have shifted capacity constraints to the downstream process. The consideration of membrane-based chromatographic devices as a debottlenecking option is gaining increasing attention with the recent introduction of high-capacity bind and elute membranes. We have evaluated the performance and scalability of the Sartobind® Rapid A affinity membrane (1 mL) for high-productivity mAb capture. For scalability assessment, a 75 mL prototype device was used to process 100 L of clarified cell culture harvest (CH) on a novel multi-use rapid cycling chromatography system (MU-RCC). MabSelect™ PrismA (4.7 mL) was used as a benchmark comparator for Protein A (ProtA) resin studies. Results show that in addition to a productivity gain of >10×, process and product quality attributes were either improved or comparable to the benchmark. Concentrations of eluate pools were 7.5× less than that of the benchmark, with the comparatively higher bulk volume likely to cause handling challenges at process scale. The MU-RCC system is capable of membrane operation at pilot scale with comparable product quality profile to the 1 mL device. The Sartobind® Rapid A membrane is a scalable alternative to conventional ProtA resin chromatography for the isolation and purification of mAbs from harvested cell culture media.
Databáze: Directory of Open Access Journals
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