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Article 10.
collapse temperature data obtained by FDM to
12. Cleland JL, Lam X, Kendrick B, Yang J, Yang TH,
freeze-drying cycles, which would be of great value
Overcashier D, Brooks D, Hsu C, Carpenter JF.
in supporting cycle optimization and robustness 2001. A specific molar ratio of stabilizer to protein is
required for storage stability of a lyophilized mono-
testing in freeze-drying.
clonal antibody. J Pharm Sci 90:310 321.
13. Shire SJ, Shahrokh Z, Liu J. 2004. Challenges in
ACKNOWLEDGMENTS
the development of high protein concentration for-
mulations. J Pharm Sci 93:1390 1402.
The authors would like to thank Dr. Michael J. 14. Franks F. 1990. Freeze drying: From empiricism to
predictability. Cryo-Letters 11:93 110.
Pikal for his active participation in discussions for
15. Nail SL, Gatlin LA. 1993. Freeze-drying: Principles
bringing understanding to the results obtained
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