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Analysis of Different Affinity Membranes for the Primary Capture Step in Antibody Manufacturing

Cristiana Boi1, Simone Dimartino1, and Giulio C. Sarti2. (1) University of Bologna, Via Terracini 28, Bologna, Italy, (2) Department of Chemical Engineering, Mining and Environmental technology, University of Bologna, Via Terracini 28, Bologna, Italy

In this work, different new affinity membranes are considered for the capturing step of a monoclonal antibody production process. The membranes with immobilized protein A and synthetic ligands, have been extensively tested with pure IgG solutions and with a cell culture supernatant containing IgG1. The effects of flow rate and IgG concentration in the feed on the separation performances like binding capacity, selectivity and process yield have been studied in detail.

The behaviour and efficiency of the different affinity membranes will be presented and will be also compared with data available for protein A chromatography beads.

A model simulation study of the relevant kinetic and transport phenomena led to the development of a mathematical model capable to describe the separation process based on affinity membrane. Model validation has been successfully performed using the experimental data available for the different membrane tested.

Acknowledgement

This work has been performed as part of the “Advanced Interactive Materials by Design” (AIMs) project, supported by the Sixth Research Framework Programme of the European Union (NMP3-CT-2004-500160).