Aimee C. Kincaid

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Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

Aimee C. Kincaid;Timothy G. Hughes;Serena Donnelly Webb;Jonathan N. Webb;David F. Sesin

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.

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