Rational design of stable lyophilized protein formulations: Some practical advice

被引:531
作者
Carpenter, JF
Pikal, MJ
Chang, BS
Randolph, TW
机构
[1] UNIV COLORADO,HLTH SCI CTR,SCH PHARM,DEPT PHARMACEUT SCI,DENVER,CO 80262
[2] AMGEN INC,THOUSAND OAKS,CA 91320
[3] UNIV COLORADO,DEPT CHEM ENGN,BOULDER,CO 80309
关键词
protein drugs; design of formulations; lyophilization; stabilization of proteins;
D O I
10.1023/A:1012180707283
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
[No abstract available]
引用
收藏
页码:969 / 975
页数:7
相关论文
共 36 条
[1]   Counteracting effects of thiocyanate and sucrose on chymotrypsinogen secondary structure and aggregation during freezing, drying, and rehydration [J].
Allison, SD ;
Dong, AC ;
Carpenter, JF .
BIOPHYSICAL JOURNAL, 1996, 71 (04) :2022-2032
[2]   Polymers protect lactate dehydrogenase during freeze-drying by inhibiting dissociation in the frozen state [J].
Anchordoquy, TJ ;
Carpenter, JF .
ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS, 1996, 332 (02) :231-238
[3]   FACTORS AFFECTING SHORT-TERM AND LONG-TERM STABILITIES OF PROTEINS [J].
ARAKAWA, T ;
PRESTRELSKI, SJ ;
KENNEY, WC ;
CARPENTER, JF .
ADVANCED DRUG DELIVERY REVIEWS, 1993, 10 (01) :1-28
[4]   STABILITY OF PROTEIN FORMULATIONS - INVESTIGATION OF SURFACTANT EFFECTS BY A NOVEL EPR SPECTROSCOPIC TECHNIQUE [J].
BAM, NB ;
RANDOLPH, TW ;
CLELAND, JL .
PHARMACEUTICAL RESEARCH, 1995, 12 (01) :2-11
[5]  
Carpenter J.F., 1996, Bietechnology and biopharmaceutical manufacturing, processing, and preservation, V1996, P199
[6]   SEPARATION OF FREEZING-INDUCED AND DRYING-INDUCED DENATURATION OF LYOPHILIZED PROTEINS USING STRESS-SPECIFIC STABILIZATION .1. ENZYME-ACTIVITY AND CALORIMETRIC STUDIES [J].
CARPENTER, JF ;
PRESTRELSKI, SJ ;
ARAKAWA, T .
ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS, 1993, 303 (02) :456-464
[7]   USE OF SUBAMBIENT THERMAL-ANALYSIS TO OPTIMIZE PROTEIN LYOPHILIZATION [J].
CHANG, BS ;
RANDALL, CS .
CRYOBIOLOGY, 1992, 29 (05) :632-656
[8]   Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: Glass transition and protein conformation [J].
Chang, BS ;
Beauvais, RM ;
Dong, AC ;
Carpenter, JF .
ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS, 1996, 331 (02) :249-258
[9]   Surface-induced denaturation of proteins during freezing and its inhibition by surfactants [J].
Chang, BS ;
Kendrick, BS ;
Carpenter, JF .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1996, 85 (12) :1325-1330
[10]   STRATEGIES TO SUPPRESS AGGREGATION OF RECOMBINANT KERATINOCYTE GROWTH-FACTOR DURING LIQUID FORMULATION DEVELOPMENT [J].
CHEN, BL ;
ARAKAWA, T ;
HSU, E ;
NARHI, LO ;
TRESSEL, TJ ;
CHIEN, SL .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1994, 83 (12) :1657-1661