Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Reexamination Certificate
2001-12-26
2010-11-16
Steadman, David J (Department: 1656)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
C436S004000, C424S178100
Reexamination Certificate
active
07833525
ABSTRACT:
This invention relates to crystals of whole antibodies and fragments thereof, and formulations and compositions comprising such crystals. More particularly, methods are provided for the crystallization of high concentrations of whole antibodies, and fragments thereof, in large batches, and for the preparation of stabilized whole antibody crystals for use alone, or in dry or slurry formulations or compositions. This invention also relates to methods for stabilization, storage and delivery of biologically active whole antibody crystals.
REFERENCES:
patent: 4334024 (1982-06-01), Johal
patent: 4959351 (1990-09-01), Grau
patent: 5510118 (1996-04-01), Bosch et al.
patent: 5780599 (1998-07-01), Junker et al.
patent: 5849296 (1998-12-01), Navia et al.
patent: 5904935 (1999-05-01), Eckenhoff et al.
patent: 6011001 (2000-01-01), Navia et al.
patent: 6042824 (2000-03-01), Khalaf
patent: 6140475 (2000-10-01), Margolin et al.
patent: 6310038 (2001-10-01), Havelund
patent: WO 91/09943 (1991-07-01), None
patent: WO 96/40049 (1996-12-01), None
patent: 97/08300 (1997-03-01), None
patent: 97/44445 (1997-11-01), None
patent: 98/46732 (1998-10-01), None
patent: WO 99/55310 (1999-11-01), None
patent: WO 9955310 (1999-11-01), None
patent: WO 00/52150 (2000-09-01), None
patent: WO 00/77281 (2000-12-01), None
Harris et al. (Proteins: Struct. Funct. Genet. 1995; 23: 285-289).
Hoedemaeker et al. (J. Biol. Chem. 1997; 272 (47): 29784-29789).
Remicade (Remicade, Package Insert, Aug. 1998).
McPherson (Eur. J. Biochem. 1990; 189: 1-23).
Pollock et al. (J. Immunol. Methods 1999;231(1-2):147-57).
Creighton, T.E. (Proteins: Structures and Molecular Properties, 2nd Ed., W.H. Freeman and Company, 1993).
Drenth, “Principles of Protein X-Ray Crystallography”, 2nd Edition, 1999 Springer-Verlag New York Inc., Chapter 1, pp. 1-21.
Weber, Overview of Crystallization Methods. Methods in Enzymology, 1997, vol. 276, pp. 13-22.
Jen et al. Diamonds in the Rough: Protein Crystals from a Formulation Perspective. Pharmaceutical Research. 2001. vol. 18, No. 11, pp. 1483-1488.
Cheetham et al. “Crystal Structures of a Rat Anti-CD52 (CAMPATH-1) Therapeutic Antibody Fab Fragment and its Humanized Counterpart”. Journal of Molecular Biology. 1998. vol. 284, pp. 85-99.
Ely et al. Mobile Fc Region in the Zie IgG2 Cryoglobulin: Comparison of Crystals of the F(ab')2 Fragment and the Intact Immunoglobulin. Biochemistry. 1978. vol. 17, No. 5, pp. 820-823.
McPherson, A. Current Approaches to Macromolecular Crystallization. European Journal of Biochemistry. 1990. vol. 189, pp. 1- 23.
Kundrot, C.E. Which Strategy for a Protein Crystallization Project? Cellular Molecular Life Science. 2004. vol. 61, pp. 525-536.
Cudney R. Protein Crystallization and Dumb Luck. The Rigaku Journal. 1999. vol. 16, No. 1, pp. 1-7.
Klyushnichenko, V. Protein crystallization: From HTS to kilogram-scale. Current Opinion in Drug Discovery and Development. 2003, vol. 6, No. 6., pp. 848-854.
Chayen (2004), “Turning protein crystallisation from an art into a science”, Current Opinion in Structural Biology, 2004, 14: 577-583.
Yang et al., Crystalline monoclonal antibodies for subcutaneous delivery, PNAS Jun. 10, 2003, vol. 100, pp. 6934-6939.
Baselga et al., “Recombinant Humanized Anti-HER2 Antibody (Herceptin) Enhances the Antitumor Activity of Paclitaxel and Doxorubicin against HER2
eu Overexpressing Human Breast Cancer Xenografts,”Cancer Res, vol. 58, pp. 2825-2831 (1998).
Bertolini et al., Endostatin, an antiangiogenic drug, induces tumor stabilization after chemotherapy or anti-CD20 therapy in a NOD/SCID mouse model of human high-grade non-Hodgkin lymphoma,Neoplasia, vol. 96, pp. 282-87 (2000).
Blanco et al., “Protein encapsulation and release from poly(lactide-co-glycolide) microspheres: effect of the protein and polymer properties and of the co-encapsulation of surfactants,”Eur. J. Pharm. Biopharm. vol. 45, pp. 285-94 (1998).
Braden et al., “X-ray crystal structure of an anti-Buckminsterfullerene antibody Fab fragment: Biomolecular recognition of C60,”Proc. Natl. Acad. Sci. USA, vol. 97, pp. 12193-12197 (2000).
Brange et al., “Chemical Stability of Insulin. 1. Hydrolytic Degradation During Storage of Pharmaceutical Preparations,”)Pharm. Res., vol. 9, pp. 715-726 (1992).
Covaceuszach et al., “Purification, crystallization and preliminary X-ray analysis of the Fab fragment from MNAC13, a novel antagonistic anti-tyrosine kinase A receptor monoclonal antibody ”Acta. Crystallogr. D. Biol. Crystallogr., vol. 57, pp. 1307-1309 (2001).
Dong et al., “Secondary Structure of the Pentraxin Female Protein in Water Determined by Infrared Spectroscopy: Effects of Calcium and Phosphorylcholine,”Biochemistry, vol. 31, pp. 9364-9370 (1992).
Dong et al., “Infrared Spectroscopic Studies of Lyophilization- and Temperature-Induced Protein Aggregation,” J Pharm. Sci., vol. 84, pp 415-424 (1995).
Harris et al., “Comparison of the conformations of two intact monoclonal antibodies with hinges,”Immunol. Rev., vol. 163, pp. 35-43 (1998).
Harris et al., “Crystallographic Structure of an Intact IgG1 Monoclonal Antibody,”J. Mol. Biol., vol. 275, pp. 861-872 (1998).
Ito, et al., “Crystallization and preliminary X-ray crystallographic studies on a Fab fragment of the mouse anti-human Fas monoclonal antibody HFE7A,”Acta. Crystallogr. D. Biol. Crystallogr., vol. D57,.pp. 1700-1702 (2001).
Kim et al., “Gene therapy for established murine collagen-induced arthritis by local and systemic adenovirus-mediated delivery of interleukin-4,”Arthritis Res., vol. 2, pp. 293-302 (2000).
Küttner et al., “A phage library-derived single-chain Fv fragment in complex with turkey egg-white lysozyme: characterization, crystallization and preliminary X-ray analysis,”Molecular Immunology, vol. 35, pp. 189-194 (1998).
Malfait et al., “Chronic Relapsing Homologous Collagen-Induced Arthritis in DBA/1 Mice as a Model for Testing Disease-Modifying and Remission-Inducing Therapies,”Arthritis Rheum., vol. 44, pp. 1215-1224 (2001).
McPherson, “Preliminary Analysis: Mounting and aligning procedures,” inPreparation and Analysis of Protein Crystals, pp. 214-227 (John Wiley & Sons Publishing) (1989).
Mylvaganam et al., “Structural Basis for the Binding of an Anti-cytochromecAntibody to its Antigen: Crystal Structures of FabE8-CytochromecComplex to 1.8 Å Resolution and FabE8 to 2.26 Å Resolution,”J. Mol. Biol., vol. 281, pp. 301-322(1998).
Pekarek et al., “Double-walled polymer microspheres for controlled drug release,”Nature, vol. 367, pp. 258-260 (1994).
Pichla et al. “The Crystal Structure of a Fab Fragment to the Melanoma-Associated GD2 Ganglioside,”J. Struct. Biol., vol. 119, pp. 6-16 (1997).
Pietras et al., “Monoclonal Antibody to HER-2
euReceptor Modulates Repair of Radiation-induced DNA Damage and Enhances Radiosensitivity of Human Breast Cancer Cells Overexpressing This Oncogene,”Cancer Research, vol. 59, pp. 1347-1355 (1999).
Pikal et al., “Quantitative Crystallinity Determinations for β-Lactam Antibiotics by Solution Calorimetry: Correlations with Stability,”J. Pharm. Sci., vol. 67, pp. 767-773 (1978).
Pikal et al., “The Stability of Isulin in Crystalline and Amorphous Solids: Observation of Greater Stability for the Amorphous Form,”Pharm. Res., vol. 14, pp 1379-1387 (1997).
Rodgers, “Practical Cryocrystallography,”Methods in Enzymology, vol. 276, pp. 183-203 (1997).
Saul et al., “Structure of the Fab fragment from F124, a monoclonal antibody specific for hepatitis B surface antigen,”Acta. Crystallogr. D. Biol. Crystallogr., vol. D56, pp. 945-951 (2000).
Shenoy et al., “Stability of Crystalline Proteins,”Biotechnol. Bioeng., vol. 73, pp. 358-369 (2001).
Sohi et al., “Crystallaization and Preliminary X-ray Analysis of the Fab
Govardhan Chandrika P.
Margolin Alexey L.
Shenoy Bhami
Yang Mark X.
Cooley LLP
Kim Alexander D
Steadman David J
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