메뉴 건너뛰기




Volumn , Issue , 2010, Pages 677-704

Strategies for Bulk Storage and Shipment of Proteins

Author keywords

Bulk storage and protein shipment strategies; Business and logistic considerations, bulk storage and shipment technology and total cost of manufacturing; Cryogranulation, free flowing, frozen granules alternative means of storage for bulk drug substance

Indexed keywords


EID: 79954419528     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470595886.ch27     Document Type: Chapter
Times cited : (10)

References (45)
  • 1
    • 0030954280 scopus 로고    scopus 로고
    • Cryogranulation: A potential new final process for bulk drug substances
    • Akers, M. J. and Schmidt, D. J. (1997), Cryogranulation: A potential new final process for bulk drug substances, BioPharm 10: 28-32.
    • (1997) BioPharm , vol.10 , pp. 28-32
    • Akers, M.J.1    Schmidt, D.J.2
  • 2
    • 52449112053 scopus 로고    scopus 로고
    • High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics
    • Arford, J. R., Kendric, B. S., Carpenter, J. F., and Randolph, T. W. (2008), High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics, Journal of Pharmaceutical Sciences 97(8): 3005-3021.
    • (2008) Journal of Pharmaceutical Sciences , vol.97 , Issue.8 , pp. 3005-3021
    • Arford, J.R.1    Kendric, B.S.2    Carpenter, J.F.3    Randolph, T.W.4
  • 3
    • 35348841863 scopus 로고    scopus 로고
    • Stabilization of biopharmaceutical products and finished product formulation
    • Walsh, G. and Murphy, B., eds., Kluwer Academic Publishers
    • Hora, M. S. and Chen, B.-L. (1999), Stabilization of biopharmaceutical products and finished product formulation, in Biopharmaceutical, an Industrial Perspective, Walsh, G. and Murphy, B., eds., Kluwer Academic Publishers, pp. 217-248.
    • (1999) Biopharmaceutical, an Industrial Perspective , pp. 217-248
    • Hora, M.S.1    Chen, B.-L.2
  • 5
    • 0346846691 scopus 로고    scopus 로고
    • Effect of histidine on stability and physical properties of an antibody
    • Chen, B., Bautista, R., Yu, K., Zapata, G. A., Mulkerrin, M. G., and Chamow, S. M. (2003), Effect of histidine on stability and physical properties of an antibody, Pharm. Res. 20(12): 1952-1960.
    • (2003) Pharm. Res. , vol.20 , Issue.12 , pp. 1952-1960
    • Chen, B.1    Bautista, R.2    Yu, K.3    Zapata, G.A.4    Mulkerrin, M.G.5    Chamow, S.M.6
  • 6
    • 0030724407 scopus 로고    scopus 로고
    • Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2
    • Lam, X. M., Yang, J. Y., and Cleland, J. L. (1997), Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2, J. Pharm Sci. 86: 1250-1255.
    • (1997) J. Pharm Sci. , vol.86 , pp. 1250-1255
    • Lam, X.M.1    Yang, J.Y.2    Cleland, J.L.3
  • 11
    • 0034717156 scopus 로고    scopus 로고
    • Stability and stabilization of globular protein in solution
    • Jaenicke, R., (2000), Stability and stabilization of globular protein in solution, J. Biotechnol. 79: 193-203.
    • (2000) J. Biotechnol. , vol.79 , pp. 193-203
    • Jaenicke, R.1
  • 12
    • 0024806396 scopus 로고
    • Stability of protein pharmaceuticals
    • Manning, M. C., Patel, K., and Borchardt, R. T. (1989), Stability of protein pharmaceuticals, Pharm. Res. 6: 903-918.
    • (1989) Pharm. Res. , vol.6 , pp. 903-918
    • Manning, M.C.1    Patel, K.2    Borchardt, R.T.3
  • 13
  • 14
    • 34250781639 scopus 로고    scopus 로고
    • Protect from light: Photodegradation and protein biologics
    • Kerwin, B. and Remmele, R. L., Jr. (2007), Protect from light: Photodegradation and protein biologics, J. Pharm. Sci. 96(6): 1468-1479.
    • (2007) J. Pharm. Sci. , vol.96 , Issue.6 , pp. 1468-1479
    • Kerwin, B.1    Remmele Jr., R.L.2
  • 15
    • 14844334231 scopus 로고    scopus 로고
    • Induction and analysis of aggregates in a liquid IgG1-antibody formulation
    • Mahler, H. C., M̈uller, R., Friess, W., Delille, A., and Matheus, S. (2005), Induction and analysis of aggregates in a liquid IgG1-antibody formulation, Eur. J. Pharm. Biopharm. 59(3): 407-417.
    • (2005) Eur. J. Pharm. Biopharm. , vol.59 , Issue.3 , pp. 407-417
    • Mahler, H.C.1    M̈uller, R.2    Friess, W.3    Delille, A.4    Matheus, S.5
  • 16
    • 33749057744 scopus 로고    scopus 로고
    • Protein aggregation and bioprocessing
    • Cromwell, M. E. M., Hilario, E., and Jacobson, F. (2006), Protein aggregation and bioprocessing, AAPS J. 8(3): E572-E579.
    • (2006) AAPS J. , vol.8 , Issue.3
    • Cromwell, M.E.M.1    Hilario, E.2    Jacobson, F.3
  • 17
    • 0031822593 scopus 로고    scopus 로고
    • Investigation on fouling mechanisms for recombinant human growth hormone sterile filtration
    • Maa, Y. F., and Hsu, C. C. (1998), Investigation on fouling mechanisms for recombinant human growth hormone sterile filtration, J. Pharm. Sci. 87(7): 808-812.
    • (1998) J. Pharm. Sci. , vol.87 , Issue.7 , pp. 808-812
    • Maa, Y.F.1    Hsu, C.C.2
  • 18
    • 32644484736 scopus 로고    scopus 로고
    • Effects of ultra-/diafiltration conditions on present aggregates in human immunoglobulin G preparations
    • Ahrer, K., Buchacher, A., Iberer, G., and Jungbauer, A. (2006), Effects of ultra-/diafiltration conditions on present aggregates in human immunoglobulin G preparations, J. Membrane Sci. 274(1-2): 5 108-115.
    • (2006) J. Membrane Sci. , vol.274 , Issue.1-2
    • Ahrer, K.1    Buchacher, A.2    Iberer, G.3    Jungbauer, A.4
  • 19
    • 0001189346 scopus 로고
    • Introduction to formulation of protein pharmaceuticals
    • Ahern, T. J. and Manning, M. C., eds., Plenum Press, New York
    • Hanson, M. A. and Rouan, S. K. E. (1992), Introduction to formulation of protein pharmaceuticals, in Stability of Protein Pharmaceuticals, Ahern, T. J. and Manning, M. C., eds., Plenum Press, New York, pp. 209-233.
    • (1992) Stability of Protein Pharmaceuticals , pp. 209-233
    • Hanson, M.A.1    Rouan, S.K.E.2
  • 20
    • 0022032982 scopus 로고
    • The stabilization of proteins by osmolytes
    • Arakawa, T. and Timasheff, S. N. (1985), The stabilization of proteins by osmolytes. Biophys. J. 47: 411-414.
    • (1985) Biophys. J. , vol.47 , pp. 411-414
    • Arakawa, T.1    Timasheff, S.N.2
  • 22
    • 0024316909 scopus 로고
    • Salt precipitation during the freeze-concentration of phosphate buffer solutions
    • Murase, N. and Franks, F. (1989), Salt precipitation during the freeze-concentration of phosphate buffer solutions, Biophys. Chem. 34: 293-300.
    • (1989) Biophys. Chem. , vol.34 , pp. 293-300
    • Murase, N.1    Franks, F.2
  • 23
    • 0000711919 scopus 로고
    • Effect of freezing on the pH and composition of sodium and potassium phosphate solutions: The reciprocal system KH2PO4-Na2HPO4-H2O
    • van den Berg, L. and Rose, D. (1959), Effect of freezing on the pH and composition of sodium and potassium phosphate solutions: The reciprocal system KH2PO4-Na2HPO4-H2O, Arch. Biochem. Biophys. 81: 319-329.
    • (1959) Arch. Biochem. Biophys. , vol.81 , pp. 319-329
    • van den Berg, L.1    Rose, D.2
  • 24
    • 0035054119 scopus 로고    scopus 로고
    • Effect of initial buffer composition on pH changes during far- from-equilibrium freezing of sodium phosphate buffer solutions
    • Gomez, G., Pikal, M. J., and Rodriguez-Hornedo, N. (2001), Effect of initial buffer composition on pH changes during far- from-equilibrium freezing of sodium phosphate buffer solutions, Pharm. Res. 18: 90-97.
    • (2001) Pharm. Res. , vol.18 , pp. 90-97
    • Gomez, G.1    Pikal, M.J.2    Rodriguez-Hornedo, N.3
  • 26
    • 0023025548 scopus 로고
    • Thermodynamic stability of proteins in salt solutions: A comparison of the effectiveness of protein stabilizers
    • Ahmad, F., and Bigelow, C. (1986), Thermodynamic stability of proteins in salt solutions: A comparison of the effectiveness of protein stabilizers, J. Protein Chem. 5: 355-367.
    • (1986) J. Protein Chem. , vol.5 , pp. 355-367
    • Ahmad, F.1    Bigelow, C.2
  • 27
    • 84885997610 scopus 로고
    • Freezing and thawing serum and other biological materials: Optimal procedures minimize damage and maximize shelf-life
    • Hyclone Labs., Inc., Hyclone Labs, inc. # 2 (spring 1992)
    • Hyclone Labs., Inc. (1992), Freezing and thawing serum and other biological materials: Optimal procedures minimize damage and maximize shelf-life, in Art to Science in Tissue Culture, Hyclone Labs, inc., Vol. 11, # 2 (spring 1992).
    • (1992) Art to Science in Tissue Culture , vol.11
  • 28
    • 0036281804 scopus 로고    scopus 로고
    • Surface adsorption of recombinant human interferon-γ in lyophilized and spray-lyophilized formulations
    • Webb, S. D., Golledge, S. L., Cleland, J. L., and Carpenter, J. F. (2002), Surface adsorption of recombinant human interferon-γ in lyophilized and spray-lyophilized formulations, J. Pharm. Sci. 91: 1474-1487.
    • (2002) J. Pharm. Sci. , vol.91 , pp. 1474-1487
    • Webb, S.D.1    Golledge, S.L.2    Cleland, J.L.3    Carpenter, J.F.4
  • 29
    • 0001573172 scopus 로고    scopus 로고
    • Mechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics
    • Rey, L. and May, J. eds., Marcel Dekker, New York, Chapter 6
    • Pikal, M. J. (1999), Mechanisms of protein stabilization during freeze-drying and storage: The relative importance of thermodynamic stabilization and glassy state relaxation dynamics, in Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Rey, L. and May, J. eds., Marcel Dekker, New York, Chapter 6.
    • (1999) Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
    • Pikal, M.J.1
  • 30
    • 0038351941 scopus 로고    scopus 로고
    • A new method for the determination of the unfrozen matrix concentration and the maximal freeze-concentration
    • Liesebach, J., Rades, T., and Mang, L. (2003), A new method for the determination of the unfrozen matrix concentration and the maximal freeze-concentration, Thermochim. Acta 401(2): 159-168.
    • (2003) Thermochim. Acta , vol.401 , Issue.2 , pp. 159-168
    • Liesebach, J.1    Rades, T.2    Mang, L.3
  • 32
    • 0009024951 scopus 로고    scopus 로고
    • Large-scale cryopreservation of biotherapeutic products
    • Wilkins, J., Sesin, D., and Wisniewski, R. (2001), Large-scale cryopreservation of biotherapeutic products, Innov. Pharm. Technol. 1(8): 174-180.
    • (2001) Innov. Pharm. Technol. , vol.1 , Issue.8 , pp. 174-180
    • Wilkins, J.1    Sesin, D.2    Wisniewski, R.3
  • 33
    • 84886051528 scopus 로고    scopus 로고
    • Design and testing of a prototype large-scale bag freeze-thaw system
    • Lam, P. and Sane, S. (2007), Design and testing of a prototype large-scale bag freeze-thaw system, BioPharm Int. 20: 6-16.
    • (2007) BioPharm Int. , vol.20 , pp. 6-16
    • Lam, P.1    Sane, S.2
  • 36
    • 0023905575 scopus 로고
    • The mechanism of cryoprotection of proteins by solutes
    • Carpenter, J. F. and Crowe, J. H. (1988), The mechanism of cryoprotection of proteins by solutes, Cryobiology 25: 244-255.
    • (1988) Cryobiology , vol.25 , pp. 244-255
    • Carpenter, J.F.1    Crowe, J.H.2
  • 37
    • 0034525598 scopus 로고    scopus 로고
    • Stabilizing effect of chemical additives against oxidation of lactate dehydrogenase
    • Anderson, M. M., Breccia, J. D., and Hatti-Kaul, R. (2000), Stabilizing effect of chemical additives against oxidation of lactate dehydrogenase, Biotechnol. Appl. Biochem. 32: 145-153.
    • (2000) Biotechnol. Appl. Biochem. , vol.32 , pp. 145-153
    • Anderson, M.M.1    Breccia, J.D.2    Hatti-Kaul, R.3
  • 38
    • 0030443567 scopus 로고    scopus 로고
    • Surface-induced denaturation of proteins during freezing and its inhibition by surfactants
    • Chang, B. S., Kendrick, B. S., and Carpenter, J. F. (1996), Surface-induced denaturation of proteins during freezing and its inhibition by surfactants, J. Pharm. Sci. 85: 1325-1330.
    • (1996) J. Pharm. Sci. , vol.85 , pp. 1325-1330
    • Chang, B.S.1    Kendrick, B.S.2    Carpenter, J.F.3
  • 39
    • 0031660957 scopus 로고    scopus 로고
    • Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin
    • Kerwin, B. A. et al. (1998), Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin, J. Pharm. Sci. 87(9): 1062-1068.
    • (1998) J. Pharm. Sci. , vol.87 , Issue.9 , pp. 1062-1068
    • Kerwin, B.A.1
  • 40
    • 0028925570 scopus 로고    scopus 로고
    • Protein destabilization at low temperatures
    • Franks, F. (2003), Protein destabilization at low temperatures, Adv. Protein. Chem. 46: 105-139.
    • (2003) Adv. Protein. Chem. , vol.46 , pp. 105-139
    • Franks, F.1
  • 41
    • 17644388499 scopus 로고    scopus 로고
    • Effects of excipients on the hydrogen peroxide-induced oxidation of methionine residues in granulocyte colony-stimulating factor
    • Yin, J., Chu, J.-W., Ricci, M. S., Brems, D. N., Wang, D. I. C., and Trout, B. L. Effects of excipients on the hydrogen peroxide-induced oxidation of methionine residues in granulocyte colony-stimulating factor, Pharm. Res. 22.
    • Pharm. Res. , vol.22
    • Yin, J.1    Chu, J.-W.2    Ricci, M.S.3    Brems, D.N.4    Wang, D.I.C.5    Trout, B.L.6
  • 42
    • 0025964931 scopus 로고
    • The use of pH indicators to identify suitable environments for freezing samples in aqueous and mixed aqueous/nonaqueous solutions
    • Hill, J. P. and Buckley, P. D. (1991), The use of pH indicators to identify suitable environments for freezing samples in aqueous and mixed aqueous/nonaqueous solutions, Anal. Biochem. 192(2): 358-361.
    • (1991) Anal. Biochem. , vol.192 , Issue.2 , pp. 358-361
    • Hill, J.P.1    Buckley, P.D.2
  • 43
    • 0036178469 scopus 로고    scopus 로고
    • Thermophysical properties of pharmaceutically compatible buffers at sub-zero temperatures: Implications for freeze drying
    • Shalaev, E., Johnson-Elton, T., Chang, L., and Pikal, M. J. (2002), Thermophysical properties of pharmaceutically compatible buffers at sub-zero temperatures: Implications for freeze drying, Pharm. Res. 19: 195-201.
    • (2002) Pharm. Res. , vol.19 , pp. 195-201
    • Shalaev, E.1    Johnson-Elton, T.2    Chang, L.3    Pikal, M.J.4
  • 44
    • 84886003511 scopus 로고    scopus 로고
    • MG Scientiifc Supplying Laboratories
    • MG Scientiifc Supplying Laboratories, http://www.mgscientific.com/service/plastics.asp.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.