Production of polypeptides

Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...

Reexamination Certificate

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Reexamination Certificate

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11213308

ABSTRACT:
An improved system for large scale production of proteins and/or polypeptides in cell culture, particularly in media characterized by one or more of: i) a cumulative amino acid concentration greater than about 70 mM; ii) a molar cumulative glutamine to cumulative asparagine ratio of less than about 2; iii) a molar cumulative glutamine to cumulative total amino acid ratio of less than about 0.2; iv) a molar cumulative inorganic ion to cumulative total amino acid ratio between about 0.4 to 1; or v) a combined cumulative glutamine and cumulative asparagine concentration between about 16 and 36 mM, is provided. The use of such a system allows high levels of protein production and lessens accumulation of certain undesirable factors such as ammonium and/or lactate. Additionally, culture methods including a temperature shift, typically including a decrease in temperature when the culture has reached about 20-80% of it maximal cell density, are provided. Alternatively or additionally, the present invention provides methods such that, after reaching a peak, lactate and/or ammonium levels in the culture decrease over time.

REFERENCES:
patent: 4399216 (1983-08-01), Axel et al.
patent: 4522811 (1985-06-01), Eppstein et al.
patent: 4816397 (1989-03-01), Boss et al.
patent: 4816567 (1989-03-01), Cabilly et al.
patent: 5122469 (1992-06-01), Mather et al.
patent: 5156964 (1992-10-01), Inlow et al.
patent: 5395760 (1995-03-01), Smith et al.
patent: 5447851 (1995-09-01), Beutler et al.
patent: 5538983 (1996-07-01), Buxbaum et al.
patent: 5589154 (1996-12-01), Anderson
patent: 5605690 (1997-02-01), Jacobs et al.
patent: 5658754 (1997-08-01), Kawasaki
patent: 5672502 (1997-09-01), Birch et al.
patent: 5705364 (1998-01-01), Etcheverry et al.
patent: 5712155 (1998-01-01), Smith et al.
patent: 5721121 (1998-02-01), Etcheverry et al.
patent: 5856179 (1999-01-01), Chen et al.
patent: 5871999 (1999-02-01), Boraston
patent: 5874060 (1999-02-01), Armour et al.
patent: 5976833 (1999-11-01), Furukawa et al.
patent: 6048728 (2000-04-01), Inlow et al.
patent: 6180401 (2001-01-01), Chen et al.
patent: 6291159 (2001-09-01), Winter et al.
patent: 6310185 (2001-10-01), Wallace et al.
patent: 6518415 (2003-02-01), Armour et al.
patent: 6572852 (2003-06-01), Smith et al.
patent: 6657103 (2003-12-01), Kucherlapati et al.
patent: 2004/0048368 (2004-03-01), Chen et al.
patent: 2006/0121569 (2006-06-01), Drapeau et al.
patent: 2006/0160180 (2006-07-01), Drapeau et al.
patent: 0117058 (1984-01-01), None
patent: 0117060 (1984-01-01), None
patent: 0171496 (1985-03-01), None
patent: 0173494 (1985-08-01), None
patent: 0239400 (1987-03-01), None
patent: 0417563 (1990-08-01), None
patent: 0417014 (1990-09-01), None
patent: 0481791 (1991-10-01), None
patent: 2177096 (1987-01-01), None
patent: 2251249 (1992-07-01), None
patent: 7165799 (1995-06-01), None
patent: WO92/06193 (1992-04-01), None
patent: WO93/05145 (1993-03-01), None
patent: WO95/24484 (1995-09-01), None
patent: WO96/39488 (1996-12-01), None
patent: WO98/45411 (1998-10-01), None
patent: WO 00/23082 (2000-04-01), None
patent: WO 00/72880 (2000-12-01), None
patent: WO 02/46237 (2002-06-01), None
patent: WO 02/046237 (2002-06-01), None
patent: WO 02/088306 (2002-11-01), None
patent: WO 02/088307 (2002-11-01), None
patent: WO 02/101019 (2002-12-01), None
patent: WO 03/027248 (2003-04-01), None
patent: WO 03/077858 (2003-09-01), None
patent: WO 2006/026445 (2006-03-01), None
U.S. Appl. No. 03/087,372, filed May 8, 2003, DelaCruz et al.
U.S. Appl. No. 03/104,406, filed Jun. 5, 2003, Wolfman et al.
U.S. Appl. No. 03/162,714, filed Aug. 28, 2003, Hill et al.
U.S. Appl. No. 03/180,308, filed Sep. 25, 2003, Hill et al.
U.S. Appl. No. 04/082,764, filed Apr. 29, 2004, Kunz et al.
U.S. Appl. No. 04/142,382, filed Jul. 22, 2004, Veldman et al.
U.S. Appl. No. 04/223,966, filed Nov. 11, 2004, Wolfman et al.
U.S. Appl. No. 05/106,154, filed May 19, 2005, Hill et al.
Abe et al., “The Monoclonal Antibody Directed To Difucosylated Type 2 Chain (Fucα1→2Galβ1→4[Fucα1→3]GlcNAc; Y Determinant),”J. Biol. Chem., 258: 11793-11797, 1983.
Altamirano, et al., “Improvement Of CHO Cell Culture Medium Formulation: Simultaneous Substitution Of Glucose And Glutamine,”Biotechnol. Prog., 16: 69-75, 2000.
Altamirano, et al., “Analysis Of CHO Cell Metabolic Redistribution In A Glutamate-Based Defined Medium In Continuous Culutre,”Biotechnol. Prog., 17: 1032-1041, 2001.
Bogheart et al., “Antibody-targeted Chemotherapy With The Calicheamicin Conjugate hu3S193-N-acetyl gamma Calicheamicin Dimethyl Hydrazide Targets Lewisy And Eliminates Lewisy-positive Human Carcinoma Cells And Xenografts,”Clin. Can. Res.10: 4538-49, 2004.
Boshart et al., “A Very Strong Enhancer Is Located Upstream Of An Immediate Early Gene Of Human Cytomegalovirus,”Cell41: 521-530, 1985.
Christie and Butler, “The Adaptation Of BHK Cells To A Non-Ammoniagenic Glutamate-Based Culture Medium,”Biotechn. And Bioeng., 64(3): 298-309, 1999.
Deutscher, “Setting Up A Laboratory,”Methods in Enzymology, 182: 19-23, 1990.
Deutscher, “Maintaining Protein Stability,”Methods in Enzymology, 182: 83-89, 1990.
Deutscher, “Rethinking Your Purification Procedure,”Methods in Enzymology, 182: 779-780, 1990.
DeVries et al. “Thefms-Like Tyrosine Kinase, A Receptor For Vascular Endothelial Growth Factor,”Science255: 989-991, 1992.
Dijkema et al., “Cloning And Expression Of The Chromosomal Immune Interferon Gene Of The Rat,”EMBO J.4(3): 761-767, 1985.
Drews, “Genomic Sciences And The Medicine Of Tomorrow,”Nature Biotechnology, 14: 1516-1518, 1996.
Gething et al., “Cell-surface Expression Of Influenza Haemagglutinin From A Cloned DNA Copy Of The RNA Gene,”Nature, 293: 620-625, 1981.
Gorfien, et al., “Optimized Nutrient Additives For Fed-Batch Cultures,”BioPharm International, 34-40, 2003.
Gorman et al., “The Rous Sarcoma Virus Long Terminal Repeat Is A Strong Promoter When Introduced Into A Variety Of Eukaryotic Cells By DNA-mediated Transfection,”Proc. Natl. Acad. Sci. USA79: 6777-6781, 1982.
Graham and van der Erb, “A New Technique For The Assay Of Infectivity Of Human Adenovirus 5 DNA,”Virology, 52: 456-457, 1973.
Graham et al., “Characteristics Of A Human Cell Line Transformed By DNA From Human Adenvirus Type 5,”J. Gen Virol., 36: 59-74, 1977.
Ham, “Clonal Growth Of Mammalian Cells In A Chemically Defined, Synthetic Medium,”Proc. Nat. Assoc. Sci. USA, 53: 288-293, 1965.
Jones et al., “Replacing The Complementarity-determining Regions In A Human Antibody With Those From A Mouse,”Nature321: 522-525, 1986.
Keown et al., “Methods For Introducing DNA Into Mammalian Cells,”Methods in Enzymology, 185: 527-537, 1990.
Kozbor et al., “The Production Of Monoclonal Antibodies From Human Lymphocytes,”Immunology Today, 4: 72-79, 1983.
Ling, et al., “Chemically Characterized Concentrated Corodies For Continuous Cell Culture (The 7C's Culture Media),”Experimental Cell Research, 52: 469-489, 1968.
Mansour et al., “Disruption Of The Proto-oncogeneint-2 In Mouse Embryo-derived Stem Cells: A General Strategy For Targeting Mutations To Non-selectable Genes,”Nature, 336: 348-352, 1988.
Mantei et al., “Rabbit β-globin mRNA Production In Mouse L Cells Transformed With Cloned Rabbit β-globin Chromosomal DNA,”Nature, 281: 40-46, 1979.
Mather, “Establishment And Characterization Of Two Distinct Mouse Testicular Epithelial Cell Lines,”Biol. Reprod., 23: 243-252, 1980.
Mather et al., “Culture Of Testicular Cells In Hormone-supplemented Serum-free Medium,”Annals N.Y. Acad. Sci., 383: 44-68, 1982.
Milligan and Rees, “Chimaeric Gα Proteins: Their Potential Use In Drug Discovery,”TIPS, 20: 118-124, 1999.
Milstein and Cuello, “Hybrid Hybridomas And Their Use

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