Ultrahigh‐speed, ultrahigh‐resolution preparative separation of protein biopharmaceuticals using membrane chromatography

Abstract

This paper discusses ultrahigh-speed, ultrahigh-resolution preparative protein separation using an in-house designed membrane chromatography device. The performance of the membrane chromatography device was systematically compared with an equivalent resin-packed preparative column. Experiments carried out using model proteins showed that membrane chromatography gave more than four times greater resolution than the preparative column, while at the same time being more than 19 times faster. Membrane chromatography was therefore a better option, not only in terms of higher productivity but also in terms of higher product purity. Membrane chromatography was also superior in terms of resolving and presenting tracer impurity peaks in the chromatogram. Experiments carried out using monoclonal antibody samples showed that membrane chromatography was suitable for ultrahigh speed, and ultrahigh resolution fractionation of charge variants. This paper highlights and explains the need for proper device design for enabling the use of membrane chromatography for the efficient purification of protein biopharmaceuticals.

Comparative Evaluation of Commercial Protein A Membranes for the Rapid Purification of Antibodies

“…Peak tailing is tied to flow distribution and the specific format of the membrane adsorber device [ 39 , 40 ]. All membrane adsorbers evaluated in this study operate in direct-flow format.…”

Toward microfluidic continuous-flow and intelligent downstream processing of biopharmaceuticals

“…96 Furthermore, for the swift purification of large volumes, membrane chromatography could be a promising approach. 97,98 Meanwhile the development of microfluidic multimodal chromatography strategies is suggested to be considered to further minimize the number of chromatography processes. 99 Recent advancements involve the integration of microfluidic systems with automation technology, enabling high-throughput screening for the analysis of various process parameters and product quality.…”

Recent development and application of membrane chromatography

“…Membrane chromatography on a commercial scale was not widely accepted until 2012. At present, membrane chromatography has been widely used in the fields of virus and endotoxins, monoclonal antibody purification, protein capture and intermediate purification, and water treatment [ 19 ].…”