Assessment of protein stability during freeze-thaw process

BIOT 11

Kapil Gupta, kgupta@amgen.com1, Nitin Rathore, nrathore@amgen.com2, Lorena Barron2, Wenchang Ji3, Feroz Jameel3, and Keith Murphy3. (1) Drug Product and Device Development, Amgen, Mail stop 30W- 3-A , one amgen center drive, Thousand oaks, CA 91320, (2) Global Drug Product & Device Development, Amgen Inc, MS 30W-3-A, One Amgen Center Drive, Thousand Oaks, CA 91320, (3) Global Drug Product & Device Development, Amgen, MS 30W-3-A, One Amgen Center Drive, Thousand Oaks, CA 91320
Biopharmaceutical industries often rely on frozen storage of the bulk material due to the increased physical and chemical stability in the frozen state compared to the liquid state. However, freezing and thawing at large scale may have impact on the quality of protein products due to cryoconcentration, ice-surface induced denaturation and cold denaturation. One potential way to minimize freeze-thaw induced protein instability is by controlling the rates of the freezing and thawing processes. This study evaluates the effect of controlling the freeze rate and freeze front velocity on the product quality. In this evaluation, Celsius-pak© disposable bag technology is used for controlled freeze-thaw operation while uncontrolled freeze-thaw is performed in polycarbonate bottles.
 

Biophysical and Biomolecular Symposium: Protein Stability
8:00 AM-11:10 AM, Sunday, August 19, 2007 BCEC -- 107 A/B, Oral

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007