Redistribution of Protein Biological Activity in a Freeze-Dried Cake

REFERENCES

• Liapis , A.I. ; Pikal , M.J. ; Bruttini , R. Research and development needs and opportunities in freeze drying . Drying Technology 1996 , 14 , 1265 – 1300 .
   Web of Science ®Google Scholar
• Liapis , A.I. ; Bruttini , R. Freeze drying . In Handbook of Industrial Drying, , 3rd Ed .; Mujumdar , A.S. , Ed.; CRC Press : Boca Raton , FL , 2007 ; 257 – 283 .
   Google Scholar
• Carpenter , J.F. ; Pikal , M.J. ; Chang , B.S. ; Randolph , T.W. Rational design of stable lyophilized protein formulations: Some practical advice . Pharmaceutical Research 1997 , 14 , 969 – 975 .
   PubMed Web of Science ®Google Scholar
• Tang , X. ; Pikal , M.J. Design of freeze-drying processes for pharmaceuticals: Practical advice . Pharmaceutical Research 2004 , 21 , 191 – 200 .
   PubMed Web of Science ®Google Scholar
• Bhatnagar , B. ; Bogner , R.H. ; Pikal , M.J. Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization . Pharmaceutical Development and Technology 2007 , 12 , 505 – 523 .
   PubMed Web of Science ®Google Scholar
• Halde , R. Concentration of impurities by progressive freezing . Water Research 1979 , 14 , 575 – 580 .
   Web of Science ®Google Scholar
• Chen , Y.H. ; Cao , E. ; Cui , Z.F. An experimental study of freeze concentration in biological media . Food and Bioproducts Processing 2001 , 79 , 35 – 40 .
   Web of Science ®Google Scholar
• Fukui , K. ; Kouuchi , S. ; Asakuma , Y. ; Maeda , K. Distribution of cations in ice grown on a rotating cold cylinder . Journal of Chemical Engineering of Japan 2008 , 41 , 344 – 349 .
   Web of Science ®Google Scholar
• Nakagawa , K. ; Maebashi , S. ; Maeda , K. Concentration of aqueous dye solution by freezing and thawing . Canadian Journal of Chemical Engineering 2009 , 87 , 779 – 787 .
   Web of Science ®Google Scholar
• Nakagawa , K. ; Nagahama , H. ; Maebashi , S. ; Maeda , K. Usefulness of solute elution from frozen matrix for freeze-concentration technique . Chemical Engineering Research and Design 2010 , 88 , 718 – 724 .
   Web of Science ®Google Scholar
• Privalov , P.L. Cold denaturation of proteins . Critical Reviews in Biochemistry and Molecular Biology 1990 , 25 , 281 – 305 .
   PubMed Web of Science ®Google Scholar
• Arakawa , T. ; Kita , Y. ; Carpenter , J.F. Protein–solvent interactions in pharmaceutical formulations . Pharmaceutical Research 1991 , 8 , 285 – 291 .
   PubMed Web of Science ®Google Scholar
• Tang , X.C. ; Pikal , M.J. The effect of stabilizers and denaturants on the cold denaturation temperatures of proteins and implications for freeze-drying . Pharmaceutical Research 2005 , 22 ( 7 ), 1167 – 1175 .
   PubMed Web of Science ®Google Scholar
• Strambini , G.B. ; Gabellieri , E. Proteins in frozen solutions: Evidence of ice-induced partial unfolding . Biophysics Journal 1996 , 70 , 971 – 976 .
   PubMed Web of Science ®Google Scholar
• Chang , B.S. ; Kendrick , B.S. ; Carpenter , J.F. Surface-induced denaturation of proteins during freezing and its inhibition by surfactant . Journal of Pharmaceutical Sciences 1996 , 85 , 1325 – 1330 .
   PubMed Web of Science ®Google Scholar
• Bhatnagar , B. ; Pikal , M.J. ; Bogner , R.H. Study of the individual contributions of ice formation and freeze-concentration on isothermal stability of lactate dehydrogenase during freezing . Journal of Pharmaceutical Sciences 2008 , 97 , 798 – 814 .
   PubMed Web of Science ®Google Scholar
• Eckhardt , B.M. ; Oeswein , J.Q. ; Bewley , T.A. Effect of freezing on aggregation of human growth hormone . Pharmaceutical Research 1991 , 8 , 1360 – 1364 .
   PubMed Web of Science ®Google Scholar
• Pikal , M.J. ; Dellerman , K.M. ; Roy , M.L. ; Riggin , R.M. The effects of formulation variables on the stability of freeze-dried human growth hormone . Pharmaceutical Research 1991 , 8 , 427 – 436 .
   PubMed Web of Science ®Google Scholar
• Sarciaux , J.M. ; Mansour , S. ; Hageman , M.J. ; Nail , S.L. Effect of buffer composition and processing conditions on aggregation of bovine IgG during freeze-drying . Journal of Pharmaceutical Sciences 1999 , 88 , 1354 – 1361 .
   PubMed Web of Science ®Google Scholar
• Grinberg , V.Y. ; Tolstoguzov , V.B. Thermodynamic incompatibility of proteins and polysaccharides in solutions . Food Hydrocolloids 1997 , 11 , 145 – 158 .
   Web of Science ®Google Scholar
• Heller , M.C. ; Carpenter , J.F. ; Randolph , T.W. Manipulation of lyophilisation-induced phase separation: Implications for pharmaceutical proteins . Biotechnology Progress 1997 , 13 , 590 – 596 .
   PubMed Web of Science ®Google Scholar
• Arakawa , T. ; Prestrelski , S.J. ; Kenny , W.C. ; Carpenter , J.F. Factors affecting short-term and long term stabilities of proteins . Advanced Drug Delivery Reviews 1993 , 10 , 1 – 28 .
   Web of Science ®Google Scholar
• Prestrelski , S.J. ; Arakawa , T. ; Carpenter , J.F. Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization . Archives of Biochemistry and Biophysics 1993 , 303 , 465 – 473 .
   PubMed Web of Science ®Google Scholar
• Pikal , M.J. Mechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics. In Freeze-Drying/Lyophilisation of Pharmaceutical and Biological Products , Vol. 137; Rey , L. ; May , J.C. , Eds.; Marcel Dekker Inc. : New York , 2004; 63–107.
   Google Scholar
• Carpenter , J.F. ; Crowe , J.H. Modes of stabilization of a protein by organic solutes during desiccation . Cryobiology 1988 , 25 , 459 – 470 .
   Web of Science ®Google Scholar
• Suzuki , T. ; Imamura , K. ; Fujimoto , H. ; Okazaki , M. Role of sucrose–LDH hydrogen bond for thermal stabilizing effect of sucrose on freeze-dried LDH . Drying Technology 1999 , 17 , 1429 – 1439 .
   Web of Science ®Google Scholar
• Imamura , K. ; Ogawa , T. ; Sakiyama , T. ; Nakanishi , K. Effect of types of sugar on the stabilization of protein in the dried state . Journal of Pharmaceutical Sciences 2003 , 92 , 266 – 274 .
   PubMed Web of Science ®Google Scholar
• Izutsu , K. ; Kojima , S. Excipient crystallinity and its protein structure stabilizing effect during freeze-drying . Journal of Pharmacy and Pharmacology 2002 , 54 , 1033 – 1039 .
   PubMed Web of Science ®Google Scholar
• Schwegman , J.J. ; Hardwick , L.M. ; Akers , M.J. Practical formulation and process development of freeze-dried products . Pharmaceutical Development and Technology 2005 , 10 , 151 – 173 .
   PubMed Web of Science ®Google Scholar
• Nakagawa , K. ; Murakami , W. ; Andrieu , J. ; Vessot , S. Freezing step controls the mannitol phase composition heterogeneity . Chemical Engineering Research and Design 2009 , 87 , 1017 – 1027 .
   Web of Science ®Google Scholar
• Nakagawa , K. ; Hottot , A. ; Vessot , S. ; Andrieu , J. Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceutical proteins freeze-drying . Chemical Engineering and Processing 2006 , 45 , 783 – 791 .
   Web of Science ®Google Scholar
• Nakagawa , K. ; Hottot , A. ; Vessot , S. ; Andrieu , J. Modelling of freezing steps during freeze-drying of drugs in vials . AIChE Journal 2007 , 53 , 1362 – 1372 .
   Web of Science ®Google Scholar
• Barresi , A.A. ; Ghio , S. ; Fissore , D. ; Pisano , R. Freeze drying of pharmaceutical excipients close to collapse temperature: Influence of the process conditions on process time and product quality . Drying Technology 2009 , 27 , 805 – 816 .
   Web of Science ®Google Scholar
• Sadikoglu , H. ; Liapis , A.I. ; Crosser , O.K. Optimal control of the primary and secondary drying stage of bulk solution freeze drying . Drying Technology 1998 , 16 , 399 – 431 .
   Web of Science ®Google Scholar
• Cao , E. ; Chen , Y. ; Cui , Z. ; Foster , P.R. Effect of freezing and thawing rates on denaturation of proteins in aqueous solutions . Biotechnology and Bioengineering 2003 , 82 , 684 – 690 .
   PubMed Web of Science ®Google Scholar
• Searles , J.A. ; Carpenter , J.F. ; Randolph , T. The ice nucleation temperature determines the primary drying rate of lyophilisation for samples frozen on a temperature-controlled shelf . Journal of Pharmaceutical Science 2001 , 90 , 860 – 871 .
   PubMed Web of Science ®Google Scholar
• Tong , X.D. ; Sun , Y. Agar-based magnetic affinity support for protein adsorption . Biotechnology Progress 2001 , 17 , 738 – 743 .
   PubMed Web of Science ®Google Scholar