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Separation of Monoclonal Antibody Aggregates Using an Analytical Ultrafiltration Technique
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DOI：10.3390/membranes16060207.png)
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Abstract
En 中文
Size exclusion chromatography is the industry-standard method for measuring aggregate content in monoclonal antibody samples. In this paper, we present an orthogonal analytical technique based on ultrafiltration for detecting and quantifying monoclonal antibody aggregates. The sample to be analyzed was injected into the system in the ultrafiltration mode, and the monomeric monoclonal antibody molecules were detected in the form of a permeate peak. The system was then switched to backflow mode, and the aggregates were recovered and detected in the form of a retained species peak. The aggregate content in a given sample was quantified based on the relative peak areas, akin to that in liquid chromatography. Two monoclonal antibodies were tested in this study using the proposed analytical ultrafiltration technique. Size exclusion chromatography served as the control technique. The data obtained using the two techniques were found to be in good agreement. The advantages and limitations of the proposed analytical ultrafiltration technique are discussed.
Keywords:
analytical ultrafiltration
membrane
monoclonal antibody
aggregates
analysis
Journal
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3.6
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5.0K
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