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Humana, New York, pp 59–72
12. Searles JA, Carpenter JF, Randolph TW (2001)
Annealing to optimize primary drying rate,
reduce freeze-induced drying rate heterogeneity and determine the Tg in pharmaceutical
lyophilization. J Pharm Sci 90:872–877
13. Jiang S, Nail SL (1998) Effect of process conditions on recovery of protein activity after
freezing and freeze-drying. Eur J Pharm Biopharm 45:245–257
14. Breen ED, Curley JG, Overcashier DE, Hsu
CC, Shire SJ (2001) Effect of moisture on the
stability of a lyophilized humanised monoclonal antibody formulation. Pharm Res
18:1345–1353
15. May JC, Wheeler RM, Etz N, Del Grosso A
(1992) Measurement of final container residual
moisture in freeze dried biological products.
Dev Biol Stand 74:153–164
16. Kirkwood TBL (1984) Design and analysis of
accelerated degradation tests for the stability of
biological standards III. Principles of design. J
Biol Stand 12:215–224
702
Baolin Liu and Xinli Zhou
Humana, New York, pp 59–72
12. Searles JA, Carpenter JF, Randolph TW (2001)
Annealing to optimize primary drying rate,
reduce freeze-induced drying rate heterogeneity and determine the Tg in pharmaceutical
lyophilization. J Pharm Sci 90:872–877
13. Jiang S, Nail SL (1998) Effect of process conditions on recovery of protein activity after
freezing and freeze-drying. Eur J Pharm Biopharm 45:245–257
14. Breen ED, Curley JG, Overcashier DE, Hsu
CC, Shire SJ (2001) Effect of moisture on the
stability of a lyophilized humanised monoclonal antibody formulation. Pharm Res
18:1345–1353
15. May JC, Wheeler RM, Etz N, Del Grosso A
(1992) Measurement of final container residual
moisture in freeze dried biological products.
Dev Biol Stand 74:153–164
16. Kirkwood TBL (1984) Design and analysis of
accelerated degradation tests for the stability of
biological standards III. Principles of design. J
Biol Stand 12:215–224
702
Baolin Liu and Xinli Zhou