Quantification of Biopharmaceutically Relevant Nonionic Surfactant Excipients Using Benchtop qNMR
Ciarán C. Lynch,
Gennady Khirich,
Ryan T. Lee
Abstract:Nonionic surfactant excipients (NISEs) are commonly added
to biologics
formulations to mitigate the effects of stress incurred by the active
biotherapeutic during manufacturing, transport, and storage. During
manufacturing, NISEs are added by dilution of a stock solution directly
into a protein formulation, and their accurate addition is critical
in maintaining the quality and integrity of the drug product and thus
ensuring patient safety. This is especially true for the common NISEs,
polysorbates 20 and 80 (P… Show more
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