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Process development exploiting competitive adsorption‐based displacement effects in monoclonal antibody aggregate removal—A new high‐throughput screening procedure for membrane chromatography

Authors :
Volkmar Thom
Jürgen Hubbuch
Dominik Stein
Source :
Biotechnology and Applied Biochemistry. 69:1663-1678
Publication Year :
2021
Publisher :
Wiley, 2021.

Abstract

High-throughput screening (HTS) approaches are commonly used to accelerate downstream process development. Although most HTS approaches use batch isothermal data (KP screen) or bind and elute mode as screening procedure, different or new process designs are rarely investigated. In this paper, a mechanistic model case study for the separation of two different two-component solutions was conducted and confirmed prior evidence. With these outcomes, a novel HTS screening procedure was developed including the determination of competitive adsorption-based displacement effects and key parameter identification. The screening procedure employing an overload bind and elute (OBE) mode is presented in a case study dealing with IgG aggregate removal in a typical monoclonal antibody purification step, applying a Sartobind® S membrane adsorber (MA). Based on a MA scale down device, the OBE mode allows the determination of classical process parameters and dynamic effects, such as displacement effects. Competitive adsorption-based displacement effects are visualized by introducing a displacement identifier leading to a displacement process map. Based on this map, the approach is transferred to and confirmed by the OBE recycle experiments with 4.6 and 8.2 ml benchtop scsale devices resulting in 45% reduced IgG monomer and 88% increased higher molecular weight species binding capacities.

Details

ISSN :
14708744 and 08854513
Volume :
69
Database :
OpenAIRE
Journal :
Biotechnology and Applied Biochemistry
Accession number :
edsair.doi.dedup.....393025086063063e1c004c1336c20ee5
Full Text :
https://doi.org/10.1002/bab.2236