Effect of Product Temperature During Primary Drying on the Long-Term Stability of Lyophilized Proteins

REFERENCES

• Manning M.C., Patel K., Borchardt R.T. Stability of protein pharmaceuticals. Pharm. Res. 1989; 6: 903–918
   PubMed Web of Science ®Google Scholar
• Rey L., May J.C. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products;. Marcel Dekker, Inc, New York 1999
   Google Scholar
• Carpenter J.F., Prestrelski S.J., Arakawa T. Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. Arch. Biochem. Biophys. 1993; 303: 456–464
   PubMed Web of Science ®Google Scholar
• Carpenter J.F., Chang B.S., Garzon-Rodriguez W., Randolph T.W. Rational design of stable lyophilized protein formulations: Theory and practice. Pharm. Biotechnol. 2002; 13: 109–133
   PubMedGoogle Scholar
• Passot S., Fonseca F., Alarcon-Lorca M., Rolland D., Marin M. Physical characterisation of formulations for the development of two stable freeze-dried proteins during both dried and liquid storage. Eur. J. Pharm. Biopharm. 2005; 60: 335–348
   PubMed Web of Science ®Google Scholar
• Carpenter J.F., Crowe J.H. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry 1989; 28: 3916–3922
   PubMed Web of Science ®Google Scholar
• Franks F. Freeze-drying: From empiricism to predictability. The significance of glass transitions. Dev. Biol. Stand. 1991; 74: 9–19
   Google Scholar
• Pikal M.J. L. Rey, J.C. MayMechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics. Freeze-Drying/Lyophilisation of Pharmaceutical and Biological Products, . Marcel Dekker, New York 1999; 96: 161–198
   Google Scholar
• Pikal M.J., Shah S., Senior D., Lang J.E. Physical chemistry of freeze-drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J. Pharm. Sci. 1983; 72: 635–650
   PubMed Web of Science ®Google Scholar
• Chang B.S., Fischer N.L. Development of an efficient single-step freeze-drying cycle for protein formulations. Pharm. Res. 1995; 12: 831–837
   PubMed Web of Science ®Google Scholar
• Jennings T.A. Lyophilization: Introduction and Basic Principles. Interpharm/CRC, Boca Raton 1999
   Google Scholar
• Oetjen G.W. Industrial freeze-drying for pharmaceutical applications. Drugs Pharm. Sci. 1999; 96: 267–335
   Google Scholar
• Bellows R.J., King C.J. Freeze-drying of aqueous solutions maximum allowable. Cryobiology 1972; 9: 559–561
   PubMed Web of Science ®Google Scholar
• Bellows R.J., King C.J. Product collapse during freeze-drying of liquid foods. AICHE Symposium Series 1973; 69: 33–41
   Google Scholar
• Adams G.D.J., Irons L.I. Some implications of structural collapse during freeze-drying using Erwinia caratovora L-asparaginase as a model. J. Chem. Tech. Biotechnol. 1993; 58: 71–76
   PubMed Web of Science ®Google Scholar
• Nail S.L., Her L.M., Proffitt C.P.B., Nail L.L. An improved microscope stage for direct observation of freezing and freeze drying. Pharm. Res. 1994; 11: 1098–1100
   PubMed Web of Science ®Google Scholar
• Adams G.D.J, Ramsay J.R. Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-Asparaginase. J. Pharm. Sci. 1996; 85: 1301–1305
   PubMed Web of Science ®Google Scholar
• Shalaev E.Y., Franks F. Changes in the physical state of model mixtures during freezing and drying: Impact on product quality Cryobiology. 1996; 33: 14–26
   Google Scholar
• MacKenzie A.P. S.A. Goldblith, L. Rey, W.W. RothmayrCollapse during freeze-drying—Qualitative and quantitative aspects. Freeze-Drying and Advanced Food Technology, . Academic Press, New York 1974; 277–307
   Google Scholar
• Pikal M.J., Shah S. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy state. Int. J. Pharm. 1990; 62: 165–186
   Web of Science ®Google Scholar
• Sun W.Q. Temperature and viscosity for structural collapse and crystallization of amorphous carbohydrate solutions. Cryo-Lett. 1997; 18: 99–106
   Web of Science ®Google Scholar
• Fonseca F., Passot S., Cunin O., Marin M. Collapse Temperature of Freeze-Dried Lactobacillus bulgaricus Suspensions and Protective Media. Biotechnol. Prog. 2004; 20: 229–238
   PubMed Web of Science ®Google Scholar
• Passot S., Fonseca F., Marin M. Compositions pour la lyophilisation de protéines. French Patent n°05/00791, 2005
   Google Scholar
• 24. NIST Chemistry WebBook, NIST Standard Reference Database Number 69-March 2003 Release.
   Google Scholar
• ASTM. Standard test method for glass transition temperatures by differential scanning calorimetry or differential thermal analysis. 1991; 1356–1391
   Google Scholar
• Genin N., René F., Corrieu G. A method for on-line determination of residual water content and sublimation end-point during freeze-drying. Chem. Eng. Process. 1996; 35: 255–263
   Web of Science ®Google Scholar
• Chang B., Randall C. Use a subambient thermal analysis to optimize protein-lyophilization. Cryobiology 1992; 29: 632–656
   Web of Science ®Google Scholar
• Kasraian K., Spitznagel T.M., Juneau J.A., Yim K. Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy. Pharm. Dev. Technol. 1998; 3: 233–239
   PubMedGoogle Scholar
• Nail S.L., Jiang S., Chongprasert S., Knopp S.A. S.L. Nail, M.J. AkersFundamentals of freeze-drying. Development and Manufacture of Protein Pharmaceutical, . Kluwer Academic/Plenum Plubishers, New York 2002; 281–360
   Google Scholar
• Cavatur R.K., Vermuri N.M., Pyne A., Chrzan Z., Toledo-Velasquez D., Suryanarayanan R. Crystallization behavior of mannitol in frozen aqueous solutions. Pharm. Res. 2002; 19: 894–900
   PubMed Web of Science ®Google Scholar
• Pyne A., Surana R., Suryanarayanan R. Crystallization of mannitol below Tg′ during freeze-drying in binary and ternary aqueous systems. Pharm. Res. 2002; 19: 901–908
   PubMed Web of Science ®Google Scholar
• Lai M.C., Hageman M.J., Schowen R.L., Borchardt R.T., Topp E.M. Chemical stability of peptides in polymers. 1. Effect of water on peptide deamidation in poly(vinyl alcohol) and poly(vinyl pyrrolidone) matrixes. J. Pharm. Sci. 1999; 88: 1073–1080
   PubMed Web of Science ®Google Scholar
• Lai M.C., Hageman M.J., Schowen R.L., Borchardt R.T., Laird B.B., Topp E.M. Chemical stability of peptides in polymers. 2. Discriminating between solvent and plasticizing effects of water on peptide deamidation in poly(vinylpyrrolidone). J. Pharm. Sci. 1999; 88: 1081–1089
   PubMed Web of Science ®Google Scholar
• Streetfland L., Auffrey A.D., Franks F. Bond cleavage reactions in solid aqueous carbohydrate solution. Pharm. Res. 1998; 15: 843–849
   PubMed Web of Science ®Google Scholar
• Hancock B.C., Shamblin S.L., Zografi G. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm. Res. 1995; 12: 799–806
   PubMed Web of Science ®Google Scholar
• Hancock B.C., Zografi G. Characteristics and significance of the amorphous state in pharmaceutical systems. J. Pharm. Sci. 1997; 86: 1–12
   PubMed Web of Science ®Google Scholar
• Yoshioka S., Aso Y., Kojima S. Dependence of the molecular mobility and protein stability of freeze-dried g-globulin formulations on the molecular weight of dextran. Pharm. Res. 1997; 14: 736–741
   PubMed Web of Science ®Google Scholar
• Craig D.Q.M., Royall P.G., Kett V.L., Hopton M.L. The relevance of the amorphous state to pharmaceutical dosage forms: Glassy drugs and freeze dried systems. Int. J. Pharm. 1999; 179: 179–207
   PubMed Web of Science ®Google Scholar
• Chatterjee K., Shalaev E.Y., Suryanarayanan R. Partially crystalline systems in lyophilization. II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery. J. Pharm. Sci. 2005; 94: 809–820
   PubMed Web of Science ®Google Scholar
• Chang B.S., Beauvais R.M., Dong A., Carpenter J.F. Physical factors affecting the storage stability of freeze-dried Interleukin-1 receptor antagonist: Glass transition and protein conformation. Arch. Biochem. Biophys. 1996; 331: 249–258
   PubMed Web of Science ®Google Scholar
• Klibanov A.M., Schefiliti J.A. On the relationship between conformation and stability in solid pharmaceutical protein formulations. Biotechnol. Lett. 2004; 26: 1103–1106
   PubMed Web of Science ®Google Scholar
• Lueckel B., Helk B., Bodmer D., Leuenberger H. Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage. Pharm. Dev. Technol. 1998; 3: 337–346
   PubMedGoogle Scholar
• Wang D.Q., Hey J.M., Nail S.L. Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase. J. Pharm. Sci. 2004; 93: 1253–1263
   PubMed Web of Science ®Google Scholar