N-Glycosylation Design and Control of Therapeutic Monoclonal Antibodies.

[1]  Peter G. Slade,et al.  Mannose metabolism in recombinant CHO cells and its effect on IgG glycosylation , 2016, Biotechnology and bioengineering.

[2]  D. Weilguny,et al.  Dynamics of immature mAb glycoform secretion during CHO cell culture: An integrated modelling framework. , 2016, Biotechnology journal.

[3]  Rafael S. Costa,et al.  Kinetic modeling of cell metabolism for microbial production. , 2016, Journal of biotechnology.

[4]  Cleo Kontoravdi,et al.  A multi‐pronged investigation into the effect of glucose starvation and culture duration on fed‐batch CHO cell culture , 2015, Biotechnology and bioengineering.

[5]  Jianwei Zhu,et al.  Functional knockout of FUT8 in Chinese hamster ovary cells using CRISPR/Cas9 to produce a defucosylated antibody , 2015 .

[6]  Brittney Livingston,et al.  Real‐time product attribute control to manufacture antibodies with defined N‐linked glycan levels , 2015, Biotechnology progress.

[7]  Chi‐Huey Wong,et al.  A common glycan structure on immunoglobulin G for enhancement of effector functions , 2015, Proceedings of the National Academy of Sciences.

[8]  G. Lee,et al.  Understanding of altered N‐glycosylation‐related gene expression in recombinant Chinese hamster ovary cells subjected to elevated ammonium concentration by digital mRNA counting , 2015, Biotechnology and bioengineering.

[9]  Chung-Jr Huang,et al.  A robust method for increasing Fc glycan high mannose level of recombinant antibodies , 2015, Biotechnology and bioengineering.

[10]  Cleo Kontoravdi,et al.  How does mild hypothermia affect monoclonal antibody glycosylation? , 2015, Biotechnology and bioengineering.

[11]  John E. Schiel,et al.  Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody. , 2015, Journal of pharmaceutical sciences.

[12]  Hervé Broly,et al.  Tailoring recombinant protein quality by rational media design , 2015, Biotechnology progress.

[13]  M. Andersen,et al.  Amino acid and glucose metabolism in fed‐batch CHO cell culture affects antibody production and glycosylation , 2015, Biotechnology and bioengineering.

[14]  Andrew G. McDonald,et al.  Galactosyltransferase 4 is a major control point for glycan branching in N-linked glycosylation , 2014, Journal of Cell Science.

[15]  M. Butler,et al.  The choice of mammalian cell host and possibilities for glycosylation engineering. , 2014, Current opinion in biotechnology.

[16]  M. Caldwell,et al.  Glycosylation-related genes in NS0 cells are insensitive to moderately elevated ammonium concentrations. , 2014, Journal of biotechnology.

[17]  Mingzhi Huang,et al.  Impacts of high β-galactosidase expression on central metabolism of recombinant Pichia pastoris GS115 using glucose as sole carbon source via (13)C metabolic flux analysis. , 2014, Journal of biotechnology.

[18]  Devesh Radhakrishnan,et al.  Identification of manipulated variables for a glycosylation control strategy , 2014, Biotechnology and bioengineering.

[19]  M. Butler,et al.  Effects of nutrient levels and average culture pH on the glycosylation pattern of camelid-humanized monoclonal antibody. , 2014, Journal of biotechnology.

[20]  Neil A. McCracken,et al.  Control of galactosylated glycoforms distribution in cell culture system , 2014, Biotechnology progress.

[21]  H. Ohtake,et al.  Glycosylation analysis of an aggregated antibody produced by Chinese hamster ovary cells in bioreactor culture. , 2014, Journal of bioscience and bioengineering.

[22]  Philip M. Jedrzejewski,et al.  Towards Controlling the Glycoform: A Model Framework Linking Extracellular Metabolites to Antibody Glycosylation , 2014, International journal of molecular sciences.

[23]  Babatunde A. Ogunnaike,et al.  Controllability Analysis of Protein Glycosylation in Cho Cells , 2014, PloS one.

[24]  Averina Nicolae,et al.  Dynamics of growth and metabolism controlled by glutamine availability in Chinese hamster ovary cells , 2014, Applied Microbiology and Biotechnology.

[25]  Jamey D. Young,et al.  Role of Chinese hamster ovary central carbon metabolism in controlling the quality of secreted biotherapeutic proteins , 2014 .

[26]  H. Perreault,et al.  The availability of glucose to CHO cells affects the intracellular lipid-linked oligosaccharide distribution, site occupancy and the N-glycosylation profile of a monoclonal antibody. , 2014, Journal of biotechnology.

[27]  Saurabh Aggarwal,et al.  What's fueling the biotech engine—2012 to 2013 , 2014, Nature Biotechnology.

[28]  G. Lee,et al.  Effect of glucose feeding on the glycosylation quality of antibody produced by a human cell line, F2N78, in fed-batch culture , 2014, Applied Microbiology and Biotechnology.

[29]  Cleo Kontoravdi,et al.  A quantitative and mechanistic model for monoclonal antibody glycosylation as a function of nutrient availability during cell culture , 2013, BMC Proceedings.

[30]  Cleo Kontoravdi,et al.  Integration of models and experimentation to optimise the production of potential biotherapeutics. , 2013, Drug discovery today.

[31]  D. James,et al.  CHO cell line specific prediction and control of recombinant monoclonal antibody N‐glycosylation , 2013, Biotechnology and bioengineering.

[32]  Kai-Ting C. Shade,et al.  Antibody Glycosylation and Inflammation , 2013 .

[33]  Gang Liu,et al.  Glycosylation Network Analysis Toolbox: a MATLAB-based environment for systems glycobiology , 2013, Bioinform..

[34]  L. Quek,et al.  Flux balance analysis of CHO cells before and after a metabolic switch from lactate production to consumption. , 2013, Biotechnology and bioengineering.

[35]  Dong-Yup Lee,et al.  LC‐MS‐based metabolic characterization of high monoclonal antibody‐producing Chinese hamster ovary cells , 2012, Biotechnology and bioengineering.

[36]  Yuan Tian,et al.  Proteomic analysis of Chinese hamster ovary cells. , 2012, Journal of proteome research.

[37]  Asher Mullard,et al.  Can next-generation antibodies offset biosimilar competition? , 2012, Nature Reviews Drug Discovery.

[38]  Niki S. C. Wong,et al.  Combined in silico modeling and metabolomics analysis to characterize fed‐batch CHO cell culture , 2012, Biotechnology and bioengineering.

[39]  Shinji Hosoi,et al.  Fucose content of monoclonal antibodies can be controlled by culture medium osmolality for high antibody-dependent cellular cytotoxicity , 2012, Cytotechnology.

[40]  M. Caldwell,et al.  Glycosylation and post-translational modification gene expression analysis by DNA microarrays for cultured mammalian cells. , 2012, Methods.

[41]  N. Borth,et al.  Growth, productivity and protein glycosylation in a CHO EpoFc producer cell line adapted to glutamine-free growth. , 2012, Journal of biotechnology.

[42]  C. Kontoravdi,et al.  A dynamic mathematical model for monoclonal antibody N‐linked glycosylation and nucleotide sugar donor transport within a maturing Golgi apparatus , 2011, Biotechnology progress.

[43]  P. Rudd,et al.  Synergizing metabolic flux analysis and nucleotide sugar metabolism to understand the control of glycosylation of recombinant protein in CHO cells , 2011, BMC biotechnology.

[44]  Marcella Yu,et al.  Effects of cell culture conditions on antibody N‐linked glycosylation—what affects high mannose 5 glycoform , 2011, Biotechnology and bioengineering.

[45]  Kelvin H. Lee,et al.  The genomic sequence of the Chinese hamster ovary (CHO)-K1 cell line , 2011, Nature Biotechnology.

[46]  Seung-Yeol Park,et al.  Enhanced sialylation of recombinant human erythropoietin in Chinese hamster ovary cells by combinatorial engineering of selected genes. , 2011, Glycobiology.

[47]  P. Bondarenko,et al.  High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. , 2011, Glycobiology.

[48]  P. V. van Berkel,et al.  Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose , 2011, Biotechnology and bioengineering.

[49]  Mariati,et al.  A functional analysis of N-glycosylation-related genes on sialylation of recombinant erythropoietin in six commonly used mammalian cell lines. , 2010, Metabolic engineering.

[50]  Niki S. C. Wong,et al.  Profiling of N‐glycosylation gene expression in CHO cell fed‐batch cultures , 2010, Biotechnology and bioengineering.

[51]  N. Borth,et al.  CHO‐K1 host cells adapted to growth in glutamine‐free medium by FACS‐assisted evolution , 2010, Biotechnology journal.

[52]  Niki S. C. Wong,et al.  An investigation of intracellular glycosylation activities in CHO cells: Effects of nucleotide sugar precursor feeding , 2010, Biotechnology and bioengineering.

[53]  Jeffrey C. Miller,et al.  Highly efficient deletion of FUT8 in CHO cell lines using zinc‐finger nucleases yields cells that produce completely nonfucosylated antibodies , 2010, Biotechnology and bioengineering.

[54]  Christian Bailly,et al.  Strategies and challenges for the next generation of therapeutic antibodies , 2010, Nature Reviews Immunology.

[55]  Abhinav A Shukla,et al.  Recent advances in large-scale production of monoclonal antibodies and related proteins. , 2010, Trends in biotechnology.

[56]  Z. Li,et al.  Optimal and consistent protein glycosylation in mammalian cell culture. , 2009, Glycobiology.

[57]  Anika Ashok,et al.  Guidance for Industry by U.S. Department of Health and Human Services—Food and Drug Administration—Center for Biologics Evaluation and Research (CBER)—February 1999 , 2009 .

[58]  Pan-Jun Kim,et al.  Centralized Modularity of N-Linked Glycosylation Pathways in Mammalian Cells , 2009, PloS one.

[59]  Seung-Yeol Park,et al.  Enhanced sialylation of recombinant erythropoietin in genetically engineered Chinese‐hamster ovary cells , 2009, Biotechnology and applied biochemistry.

[60]  J. Goergen,et al.  Influence of intracellular nucleotide and nucleotide sugar contents on recombinant interferon‐γ glycosylation during batch and fed‐batch cultures of CHO cells , 2008, Biotechnology and bioengineering.

[61]  Robert M. Anthony,et al.  Recapitulation of IVIG Anti-Inflammatory Activity with a Recombinant IgG Fc , 2008, Science.

[62]  Gang Liu,et al.  In silico Biochemical Reaction Network Analysis (IBRENA): a package for simulation and analysis of reaction networks , 2008, Bioinform..

[63]  Shigeru Iida,et al.  Double knockdown of α1,6-fucosyltransferase (FUT8) and GDP-mannose 4,6-dehydratase (GMD) in antibody-producing cells: a new strategy for generating fully non-fucosylated therapeutic antibodies with enhanced ADCC , 2007, BMC Biotechnology.

[64]  Saurabh Aggarwal,et al.  What's fueling the biotech engine? , 2007, Nature Biotechnology.

[65]  Wei-Shou Hu,et al.  Systems Analysis of N-Glycan Processing in Mammalian Cells , 2007, PloS one.

[66]  Yoshiki Yamaguchi,et al.  Structural comparison of fucosylated and nonfucosylated Fc fragments of human immunoglobulin G1. , 2007, Journal of molecular biology.

[67]  Masakazu Toi,et al.  A Nonfucosylated Anti-HER2 Antibody Augments Antibody-Dependent Cellular Cytotoxicity in Breast Cancer Patients , 2007, Clinical Cancer Research.

[68]  B. Scallon,et al.  Higher levels of sialylated Fc glycans in immunoglobulin G molecules can adversely impact functionality. , 2007, Molecular immunology.

[69]  G. N. Rogers,et al.  Amino acid and manganese supplementation modulates the glycosylation state of erythropoietin in a CHO culture system , 2007, Biotechnology and bioengineering.

[70]  Wei-Shou Hu,et al.  GlycoVis: Visualizing glycan distribution in the protein N‐glycosylation pathway in mammalian cells , 2006, Biotechnology and bioengineering.

[71]  Fikile R. Brushett,et al.  RNA interference of sialidase improves glycoprotein sialic acid content consistency , 2006, Biotechnology and bioengineering.

[72]  Samuel Moser,et al.  Modulation of therapeutic antibody effector functions by glycosylation engineering: Influence of Golgi enzyme localization domain and co‐expression of heterologous β1, 4‐N‐acetylglucosaminyltransferase III and Golgi α‐mannosidase II , 2006, Biotechnology and bioengineering.

[73]  Niki S. C. Wong,et al.  Enhancing recombinant glycoprotein sialylation through CMP‐sialic acid transporter over expression in Chinese hamster ovary cells , 2006, Biotechnology and bioengineering.

[74]  Peifeng Chen,et al.  Effects of elevated ammonium on glycosylation gene expression in CHO cells. , 2006, Metabolic engineering.

[75]  M. Betenbaugh,et al.  A mathematical model of N-linked glycosylation. , 2005, Biotechnology and bioengineering.

[76]  Jennifer S Griffiths,et al.  Gene-expression profiles for five key glycosylation genes for galactose-fed CHO cells expressing recombinant IL-4/13 cytokine trap. , 2005, Biotechnology and bioengineering.

[77]  Peifeng Chen,et al.  Effects of amino acid additions on ammonium stressed CHO cells. , 2005, Journal of biotechnology.

[78]  Gyun Min Lee,et al.  Effect of low culture temperature on specific productivity, transcription level, and heterogeneity of erythropoietin in Chinese hamster ovary cells. , 2003, Biotechnology and bioengineering.

[79]  D. James,et al.  Metabolic control of recombinant monoclonal antibody N-glycosylation in GS-NS0 cells. , 2001, Biotechnology and bioengineering.

[80]  J E Bailey,et al.  A mathematical model of N-linked glycoform biosynthesis. , 1997, Biotechnology and bioengineering.

[81]  N. Lewis,et al.  A Markov chain model for N-linked protein glycosylation--towards a low-parameter tool for model-driven glycoengineering. , 2016, Metabolic engineering.

[82]  M. Butler,et al.  Fed‐batch CHO cell t‐PA production and feed glutamine replacement to reduce ammonia production , 2013, Biotechnology progress.

[83]  R. Legge,et al.  Novel Dynamic Model to Predict the Glycosylation Pattern of Monoclonal Antibodies from Extracellular Cell Culture Conditions , 2013 .

[84]  Patrick Hossler,et al.  Protein glycosylation control in mammalian cell culture: past precedents and contemporary prospects. , 2012, Advances in biochemical engineering/biotechnology.

[85]  Patrick G. Swann,et al.  Glycosylation of Therapeutic Proteins Current Understanding of Structure-Function Relationships , 2011 .

[86]  D. James,et al.  Control of Recombinant Monoclonal Antibody Effector Functions by Fc N‐Glycan Remodeling in Vitro , 2005, Biotechnology progress.

[87]  M. Butler,et al.  Effects of Ammonia and Glucosamine on the Heterogeneity of Erythropoietin Glycoforms , 2002, Biotechnology progress.