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Ensuring product stability is of utmost importance in both downstream processing and formulation of biopharmaceuticals, encompassing monoclonal antibodies (mAbs) and recombinant proteins. The challenges posed by stresses such as shear stress and elevated temperatures during unit operations like column chromatography, filtration (including ultrafiltration/diafiltration and nanofiltration), as well as during shipment and storage, have the potential to induce protein aggregation and precipitation. This jeopardizes the drug's safety and efficacy. Thoughtfully selecting appropriate excipients can substantially alleviate the instability concerns associated with biologics throughout the downstream process, as well as during storage and transportation.
In this presentation, we will showcase case studies demonstrating how HPBCD (hydroxypropyl beta-cyclodextrin), a recognized excipient in numerous approved parenteral formulations, can enhance protein stability and mitigate the formation of visible/sub-visible particles during ultrafiltration/diafiltration (UF/DF) and accelerated stability studies of monoclonal antibodies.