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

Publication
Article
BioPharm InternationalBioPharm International-05-01-2002
Volume 15
Issue 5

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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