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Ionic liquids as synergistic stabilizers in biopharmaceuticals: controlling protein aggregation in formulation and processing
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DOI：10.1016/j.ijpharm.2026.126950.png)
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Abstract
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Ionic liquids (ILs) have emerged as a versatile class of tunable additives with growing relevance in the stabilization and processing of monoclonal antibodies (mAbs) and other therapeutic proteins. This review critically examines the application of ILs, with particular emphasis on imidazolium and choline-based systems, as synergistic additives and co-excipients for mitigating protein aggregation and enhancing stability across biopharmaceutical manufacturing workflows. Unlike previous broad reviews of ionic liquids in pharmaceutical applications, this review specifically focuses on their role as stabilizing co-excipients for therapeutic proteins and critically examines their translational relevance through comparative, regulatory, and safety-oriented perspectives across the biopharmaceutical manufacturing continuum. Rather than positioning ILs as replacements for conventional excipients, this manuscript highlights their integration into the existing formulation buffers, downstream purification steps, and alternative separation platforms to improve product robustness, recovery, and shelf life.
Keywords:
ionic liquids
therapeutic proteins
protein aggregation
stabilization
biopharmaceuticals
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5.2
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2.2W
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6.7W
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