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

May 15, 2002
Aimee C. Kincaid

,
Timothy G. Hughes

,
Serena Donnelly Webb

,
Jonathan N. Webb

,
David F. Sesin

BioPharm International, BioPharm 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.