Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach
Published 2012 View Full Article
- Home
- Publications
- Publication Search
- Publication Details
Title
Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach
Authors
Keywords
-
Journal
BIOTECHNOLOGY PROGRESS
Volume 28, Issue 3, Pages 608-622
Publisher
Wiley
Online
2012-04-04
DOI
10.1002/btpr.1548
References
Ask authors/readers for more resources
Related references
Note: Only part of the references are listed.- Bypassing glycosylation: engineering aglycosylated full-length IgG antibodies for human therapy
- (2011) Sang Taek Jung et al. CURRENT OPINION IN BIOTECHNOLOGY
- High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans
- (2011) A. M. Goetze et al. GLYCOBIOLOGY
- Rates and impact of human antibody glycation in vivo
- (2011) A. M. Goetze et al. GLYCOBIOLOGY
- Characterization of Site-Specific Glycation During Process Development of a Human Therapeutic Monoclonal Antibody
- (2011) Amanda K. Miller et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Fragmentation of monoclonal antibodies
- (2011) Josef Vlasak et al. mAbs
- Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies
- (2011) Weirong Wang et al. MOLECULAR IMMUNOLOGY
- Oxidized and Aggregated Recombinant Human Interferon Beta is Immunogenic in Human Interferon Beta Transgenic Mice
- (2011) Miranda M. C. van Beers et al. PHARMACEUTICAL RESEARCH
- Characterization of trisulfide modification in antibodies
- (2010) Sheng Gu et al. ANALYTICAL BIOCHEMISTRY
- Glycosylation of Therapeutic Proteins
- (2010) Ricardo J. Solá et al. BIODRUGS
- C-terminal lysine processing of human immunoglobulin G2 heavy chain in vivo
- (2010) Bing Cai et al. BIOTECHNOLOGY AND BIOENGINEERING
- Fragmentation of a highly purified monoclonal antibody attributed to residual CHO cell protease activity
- (2010) Sharon X. Gao et al. BIOTECHNOLOGY AND BIOENGINEERING
- Glycosylation influences on the aggregation propensity of therapeutic monoclonal antibodies
- (2010) Veysel Kayser et al. Biotechnology Journal
- Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns
- (2010) Ioscani Jimenez del Val et al. BIOTECHNOLOGY PROGRESS
- Post-translational modifications of protein biopharmaceuticals
- (2010) Gary Walsh DRUG DISCOVERY TODAY
- Protein aggregation—Pathways and influencing factors
- (2010) Wei Wang et al. INTERNATIONAL JOURNAL OF PHARMACEUTICS
- Highly glycosylated human alpha interferon: An insight into a new therapeutic candidate
- (2010) Natalia Ceaglio et al. JOURNAL OF BIOTECHNOLOGY
- An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics
- (2010) Satish K. Singh et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Impact of Product-Related Factors on Immunogenicity of Biotherapeutics
- (2010) Satish Kumar Singh JOURNAL OF PHARMACEUTICAL SCIENCES
- Endotoxin elimination in sepsis: physiology and therapeutic application
- (2010) Klaus Buttenschoen et al. LANGENBECKS ARCHIVES OF SURGERY
- Assessing monoclonal antibody product quality attribute criticality through clinical studies
- (2010) Andrew M. Goetze et al. mAbs
- Stability of IgG isotypes in serum
- (2010) Ivan Correia mAbs
- Charge variants in IgG1
- (2010) Leslie A. Khawli et al. mAbs
- The immunogenicity of humanized and fully human antibodies
- (2010) Fiona A. Harding et al. mAbs
- Post-translational Modifications Differentially Affect IgG1 Conformation and Receptor Binding
- (2010) Damian Houde et al. MOLECULAR & CELLULAR PROTEOMICS
- Naturally occurring glycan forms of human immunoglobulins G1 and G2
- (2010) Gregory C. Flynn et al. MOLECULAR IMMUNOLOGY
- Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice
- (2010) Miranda M. C. van Beers et al. PHARMACEUTICAL RESEARCH
- Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
- (2010) John den Engelsman et al. PHARMACEUTICAL RESEARCH
- In vitro methionine oxidation of escherichia coli-derived human stem cell factor: Effects on the molecular structure, biological activity, and dimerization
- (2010) Yueh-Rong Hsu et al. PROTEIN SCIENCE
- Prevalence and Isotypic Complexity of the Anti-Chinese Hamster Ovary Host Cell Protein Antibodies in Normal Human Serum
- (2009) Li Xue et al. AAPS Journal
- Role of Glycosylation in Conformational Stability, Activity, Macromolecular Interaction and Immunogenicity of Recombinant Human Factor VIII
- (2009) Matthew P. Kosloski et al. AAPS Journal
- Identification and characterization of asparagine deamidation in the light chain CDR1 of a humanized IgG1 antibody
- (2009) Josef Vlasak et al. ANALYTICAL BIOCHEMISTRY
- Human antibody Fc deamidation in vivo
- (2009) Y. Diana Liu et al. BIOLOGICALS
- Degradation of an Fc-fusion recombinant protein by host cell proteases: Identification of a CHO cathepsin D protease
- (2009) Flavie Robert et al. BIOTECHNOLOGY AND BIOENGINEERING
- Immunogenicity of aggregates of recombinant human growth hormone in mouse models
- (2009) Amber Haynes Fradkin et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Impact of methionine oxidation on the binding of human IgG1 to FcRn and Fcγ receptors
- (2009) Andrea Bertolotti-Ciarlet et al. MOLECULAR IMMUNOLOGY
- Quality by design for biopharmaceuticals
- (2009) Anurag S Rathore et al. NATURE BIOTECHNOLOGY
- Methionine oxidation in human IgG2 Fc decreases binding affinities to protein A and FcRn
- (2009) Hai Pan et al. PROTEIN SCIENCE
- IgG glycosylation analysis
- (2009) Carolin Huhn et al. PROTEOMICS
- Roadmap for implementation of quality by design (QbD) for biotechnology products
- (2009) Anurag S. Rathore TRENDS IN BIOTECHNOLOGY
- Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action
- (2009) Royston Jefferis TRENDS IN PHARMACOLOGICAL SCIENCES
- Structure and Stability Changes of Human IgG1 Fc as a Consequence of Methionine Oxidation
- (2008) Dingjiang Liu et al. BIOCHEMISTRY
- C-terminal lysine variants in fully human monoclonal antibodies: Investigation of test methods and possible causes
- (2008) Lawrence W. Dick et al. BIOTECHNOLOGY AND BIOENGINEERING
- Antibody fucosylation differentially impacts cytotoxicity mediated by NK and PMN effector cells
- (2008) M. Peipp et al. BLOOD
- Engineered Antibodies of IgG1/IgG3 Mixed Isotype with Enhanced Cytotoxic Activities
- (2008) A. Natsume et al. CANCER RESEARCH
- Terminal sugars of Fc glycans influence antibody effector functions of IgGs
- (2008) T Shantha Raju CURRENT OPINION IN IMMUNOLOGY
- Heterogeneity of Monoclonal Antibodies Revealed by Charge-Sensitive Methods
- (2008) J. Vlasak et al. CURRENT PHARMACEUTICAL BIOTECHNOLOGY
- The effect of Fc glycan forms on human IgG2 antibody clearance in humans
- (2008) X. Chen et al. GLYCOBIOLOGY
- Human IgG2 Antibody Disulfide Rearrangementin Vivo
- (2008) Y. Diana Liu et al. JOURNAL OF BIOLOGICAL CHEMISTRY
- Effect of methionine oxidation of a recombinant monoclonal antibody on the binding affinity to protein A and protein G
- (2008) Georgeen Gaza-Bulseco et al. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
- The Role of Advanced Glycation End Products in Progression and Complications of Diabetes
- (2008) Su-Yen Goh et al. JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
- Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality
- (2008) John F. Carpenter et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- The Function of the Human Interferon- 1a Glycan Determined in Vivo
- (2008) L. Dissing-Olesen et al. JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
- Post-translational Modifications of Recombinant Proteins: Significance for Biopharmaceuticals
- (2008) Nigel Jenkins et al. MOLECULAR BIOTECHNOLOGY
- Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
- (2008) Christine H. Chung et al. NEW ENGLAND JOURNAL OF MEDICINE
- Aglycosylated immunoglobulin G1 variants productively engage activating Fc receptors
- (2008) S. L. Sazinsky et al. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA
- Analysis of immunoglobulin glycosylation by LC-ESI-MS of glycopeptides and oligosaccharides
- (2008) Johannes Stadlmann et al. PROTEOMICS
- Recapitulation of IVIG Anti-Inflammatory Activity with a Recombinant IgG Fc
- (2008) R. M. Anthony et al. SCIENCE
- A study in glycation of a therapeutic recombinant humanized monoclonal antibody: Where it is, how it got there, and how it affects charge-based behavior
- (2007) Cynthia Quan et al. ANALYTICAL BIOCHEMISTRY
- Characterization of a complex glycoprotein whose variable metabolic clearance in humans is dependent on terminal N-acetylglucosamine content
- (2007) Rodney Keck et al. BIOLOGICALS
- Effect of constant and variable domain glycosylation on pharmacokinetics of therapeutic antibodies in mice
- (2007) Thomas A. Millward et al. BIOLOGICALS
- Removal of Cysteinylation from an Unpaired Sulfhydryl in the Variable Region of a Recombinant Monoclonal IgG1 Antibody Improves Homogeneity, Stability, and Biological Activity
- (2007) Douglas D. Banks et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Heterogeneity of Monoclonal Antibodies
- (2007) Hongcheng Liu et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Glycosylation of Recombinant Antibody Therapeutics
- (2005) Royston Jefferis BIOTECHNOLOGY PROGRESS
Add your recorded webinar
Do you already have a recorded webinar? Grow your audience and get more views by easily listing your recording on Peeref.
Upload NowAsk a Question. Answer a Question.
Quickly pose questions to the entire community. Debate answers and get clarity on the most important issues facing researchers.
Get Started