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Leveraging Mixed-Mode Filter During Cell Culture Harvest to Prevent Antibody Reduction
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DOI：10.1016/j.jbiotec.2026.05.001.png)
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Abstract
En 中文
• Mixed-mode Polisher ST (quaternary amine + guanidinium) uniquely prevents disulfide bond breaking across 0–100 L/m2 loading, removing Trx, TrxR and G6PD, outperforming dilution, KMnO4, Emphaze AEX filter, and L-cystine. • Guanidinium functionality is mechanistically implicated: pre-spiking HCCF with L-arginine or guanidine HCl while maintaining the pH extended stability in the 100–200 L/m2 fraction from 19.5 h to ~95.3 h and ~72.5 h, respectively, while NaCl or urea had little/no benefit. • PST delivers process benefits: 2–3 log rDNA reduction and lower rHCP post-Protein A (5–7× lower; <100 ng/mg), with favorable turbidity and differential pressure versus X0SP, and without adverse impact on product quality attributes.
Keywords:
Mixed-mode polishing
Disulfide bond stability
Guanidinium functionality
Process efficiency
Antibody reduction prevention
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