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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
- 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.
- Subjects :
- Materials science
medicine.drug_class
High-throughput screening
Biomedical Engineering
Bioengineering
Monoclonal antibody
Applied Microbiology and Biotechnology
Isothermal process
chemistry.chemical_compound
Drug Discovery
medicine
Chromatography
Aggregate (composite)
Elution
Process Chemistry and Technology
Antibodies, Monoclonal
General Medicine
Chromatography, Ion Exchange
High-Throughput Screening Assays
Monomer
Membrane
chemistry
Immunoglobulin G
Molecular Medicine
Adsorption
Displacement (fluid)
Biotechnology
Subjects
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