A straightforward methodology for designing continuous monoclonal antibody capture multi-column chromatography processes

Xhorxhi Gjoka; Karl Rogler; Richard Alexander Martino; Rene Gantier; Mark Schofield

doi:10.1016/j.chroma.2015.09.005

A straightforward methodology for designing continuous monoclonal antibody capture multi-column chromatography processes

J Chromatogr A. 2015 Oct 16:1416:38-46. doi: 10.1016/j.chroma.2015.09.005. Epub 2015 Sep 6.

Authors

Xhorxhi Gjoka¹, Karl Rogler¹, Richard Alexander Martino¹, Rene Gantier¹, Mark Schofield²

Affiliations

¹ Pall Life Sciences, Westborough, MA, USA.
² Pall Life Sciences, Westborough, MA, USA. Electronic address: Mark_Schofield@Pall.com.

PMID: 26363944
DOI: 10.1016/j.chroma.2015.09.005

Abstract

A simple process development strategy for continuous capture multi-column chromatography (MCC) is described. The approach involves a few single column breakthrough experiments, based on several simplifying observations that enable users to rapidly convert batch processes into well-designed multi-column processes. The method was validated using a BioSMB(®) (Pall Life Sciences) lab scale multi-column system and a mAb capture process employing Protein A resin. The approach enables users to optimize MCC processes based on their internal preferences and constraints without requiring any mathematical modeling expertise.

Keywords: BioSMB; Continuous bioprocess; Multi-column chromatography.

MeSH terms

Antibodies, Monoclonal / chemistry*
Chromatography, Affinity / instrumentation*
Chromatography, Affinity / methods*
Humans
Models, Theoretical
Staphylococcal Protein A / chemistry*

Substances

Antibodies, Monoclonal
Staphylococcal Protein A