Abstract
This study presents the preparation and characterization of UV-grafted polybutylene terepthalate (PBT) ion exchange nonwoven membranes for chromatographic purification of biomolecules. The PBT nonwoven was functionalized with sulfonate and secondary amine for cation and anion exchange (CEX and AEX), respectively. The anion exchange membrane showed an equilibrium static binding capacity of 1300 mg BSA/g of membrane, while the cationic membranes achieved a maximum equilibrium binding capacity of over 700 mg hIgG/g of membrane. The CEX and AEX membranes resulted in dynamic binding capacities under flow conditions, with a residence time of 0.1 min, of 200 mg hIgG/mL of membrane and 55 mg BSA/mL of membrane, respectively. The selectivity of the PBT-CEX membranes was demonstrated by purifying antibodies and antibody fragments (hIgG and scFv) from CHO cell culture supernatants in a bind-an-elute mode. The purity of the eluted samples exceeded 97%, with good log removal values (LRV) for both host cell proteins (HCPs) and DNA. The PBT-AEX nonwoven membranes exhibited a DNA LRV of 2.6 from hIgG solutions in a flow-through mode with little loss of product. These results indicate that these membranes have significant potential for use in downstream purification of biologics.
Highlights
The universal prevalence and awareness of various chronic and deadly diseases continue fueling the worldwide market demand for therapeutic proteins, vaccines, and gene vector manufacturing in the biopharmaceutical industry
The CEX and AEX membranes resulted in dynamic binding capacities under flow conditions, with a residence time of 0.1 min, of 200 mg human immunoglobulin G (hIgG)/mL of membrane and 55 mg bovine serum albumin (BSA)/mL of membrane, respectively
This study was aimed at the optimization of the dynamic binding capacities for protein binding of UV grafted nonwoven membranes modified with ion exchange ligands, and to test their specificity and selectivity in real applications aimed at the purification of proteins from complex mixtures such as Chinese Hamster Ovary (CHO) cell supernatants
Summary
The universal prevalence and awareness of various chronic and deadly diseases continue fueling the worldwide market demand for therapeutic proteins, vaccines, and gene vector manufacturing in the biopharmaceutical industry. Studies have reported that more than 80% of the total cost of the manufacturing of biotherapeutics is attributed to the downstream process isolation and purification steps [7,8]. Large scale packed resin column chromatography is the dominant unit operation used for product capture and polishing in the biopharmaceutical industry [9,10,11]. The column chromatography step, on its own, contributes a significant portion of overall manufacturing costs [10,12]
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