Impact of Product-Related Factors on Immunogenicity of Biotherapeutics

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Items 201–300 of 350

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3. Development and specificities of anti-interferon neutralizing antibodies in patients with chronic hepatitis C treated with pegylated interferon-α
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4. Sensitivity and Drug Tolerance of Antidrug Antibody Assays in Relation to Positive Control Characteristics
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5. In Vitro Immunogenicity Prediction: Bridging between Innate and Adaptive Immunity
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6. Positive charge in the complementarity-determining regions of synthetic nanobody prevents aggregation
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7. Comparability study of monocyte derived dendritic cells, primary monocytes, and THP1 cells for innate immune responses
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8. The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin
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9. Technical Decision-Making with Higher Order Structure Data: Detecting Reversible Concentration-Dependent Self-Association in a Monoclonal Antibody and a Preliminary Investigation to Eliminate It
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10. A novel approach to characterize host cell proteins associated with therapeutic monoclonal antibodies
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11. Host cell protein-mediated adjuvanticity and immunogenicity risks of biotherapeutics
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12. Identification and classification of host cell proteins during biopharmaceutical process development
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13. Factors affecting product association as a mechanism of host‐cell protein persistence in bioprocessing
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14. Application of a Best Practice Approach Using Resonant Mass Measurement for Biotherapeutic Product Characterization
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15. Product-Related Factors and Immunogenicity of Biotherapeutics
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16. Autoimmune Responses to Soluble Aggregates of Amyloidogenic Proteins Involved in Neurodegenerative Diseases: Overlapping Aggregation Prone and Autoimmunogenic regions
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17. A Platform for Preparing Homogeneous Proteinaceous Subvisible Particles With Distinct Morphologies
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18. Challenges related to the immunogenicity of parenteral recombinant proteins: Underlying mechanisms and new approaches to overcome it
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19. Impact of Stress on the Immunogenic Potential of Adalimumab
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20. Application of DNA-based hydrogels as drug delivery system for immunomodulatory therapy
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21. A new approach to quantification of mAb aggregates using peptide affinity probes
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22. Physicochemical and biological characterization of 1E10 Anti-Idiotype vaccine
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23. Assessment of Clinically Relevant Immunogenicity for mAbs; are we Over Reporting ADA?
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24. Development of advanced host cell protein enrichment and detection strategies to enable process relevant spike challenge studies
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26. Establishing endotoxin limits to enhance the reliability of in vitro immunogenicity risk assessments
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27. Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity
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28. An engineered human IgG1 CH2 domain with decreased aggregation and nonspecific binding
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29. Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis
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30. Mechanism‐Based Modeling Approaches to Quantify the Effect of Immunogenicity on the Pharmacokinetics of Therapeutic Proteins in Drug Development
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31. Molecular Investigation of the Mechanism of Non-Enzymatic Hydrolysis of Proteins and the Predictive Algorithm for Susceptibility
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32. Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
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33. RUBY® – a tetravalent (2+2) bispecific antibody format with excellent functionality and IgG-like stability, pharmacology and developability properties
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34. Effect of formulation and peptide folding on the fibrillar aggregation, gelation, and oxidation of a therapeutic peptide
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35. Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4 + T cell interleukin-2 secretion
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36. RETRACTED: Induction of heat shock protein expression in SP2/0 transgenic cells and its effect on the production of monoclonal antibodies
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37. Particulate Matter in Sterile Parenteral Products
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38. Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis
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39. Highly variable aggregation and glycosylation profiles and their roles in immunogenicity to protein-based therapeutics
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40. A review article on biosimilar infliximab SB2 in the treatment of rheumatoid arthritis
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41. Report on biopharmaceutical profile of recent biotherapeutics and insilco docking studies on target bindings of known aptamer biotherapeutics
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42. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
    Anders Soehoel, Malte Selch Larsen, Stine Timmermann · 2022 · Clinical Pharmacology in Drug Development
43. Early Characterization of Biosimilar Therapeutics
    Thomas R. Gelzleichter · 2013 · Elsevier eBooks
44. Title: insoluble proteins catch heterologous soluble proteins into inclusion bodies by intermolecular interaction of aggregating peptides
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45. Impact of lyoprotectors on protein-protein separation in the solid state: Neutron- and X-ray-scattering investigation
    Viviana Cristiglio, Michael Sztucki, Cindy Wu, Evgenyi Shalaev · 2022 · Biochimica et Biophysica Acta (BBA) - General Subjects
46. Next Generation Biopharmaceuticals: Product Development
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47. Identification of monoclonal antibody variants involved in aggregate formation – Part 2: Hydrophobicity variants
    Robina M. Meyer, Lukas Berger, Joerg Nerkamp, Stefan Scheler, Sebastian Nehring, Wolfgang Frieß · 2021 · European Journal of Pharmaceutics and Biopharmaceutics
48. Applications of Cell-Based Bioassays Measuring The Induced Expression of Endogenous Genes
    Melanie L. Moore, Jackie Ferguson, Chris J. Burns · 2014 · Bioanalysis
49. Reconstitution of L-Asparaginase in Siliconized Syringes with Shaking and Headspace Air Induces Protein Aggregation
    Tomonobu Uchino, Yasunori Miyazaki, Tomoyo Ohkawa, Takuto Yamazaki, Yoshitsugu Yanagihara, Takayuki Yoshimori, Mamoru Komatsu, Hiroshi Suzuki, Yoshiyuki Kagawa · 2015 · Chemical and Pharmaceutical Bulletin
50. Current Strategies for Pharmacokinetic Optimization
    Uli Binder, Arne Skerra · 2015 · AAPS advances in the pharmaceutical sciences series
51. Rational design of rabies vaccine formulation for enhanced stability
    Veysel Kayser, Alain Françon, Hervé Pinton, Jean-François Saluzzo, Bernhardt L. Trout · 2017 · TURKISH JOURNAL OF MEDICAL SCIENCES
52. Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome
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53. Lower injection‐site reactions and long‐term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113 : Results from a post‐hoc analysis of a double‐blind, randomized, phase III comparative study and its open‐label extension in patients with rheumatoid arthritis
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54. Comparative Evaluation of Two Methods for Preparative Fractionation of Proteinaceous Subvisible Particles—Differential Centrifugation and FACS
    Björn Boll, Emilien Folzer, Christof Finkler, Jörg Huwyler, Hanns‐Christian Mahler, Roland Schmidt, Atanas V. Koulov · 2015 · Pharmaceutical Research
55. Photodegradation of Rituximab and Critical Evaluation of Its Sensibility to Electromagnetic Radiation
    Víctor Pérez Medina Martínez, Miriam Cedillo Robles, L. Carmina Juárez-Bayardo, Carlos E. Espinosa‐de la Garza, Angélica Meneses, Néstor O. Pérez · 2022 · AAPS PharmSciTech
56. Inhibitors in haemophilia A: a perspective on clotting factor products as a potential contributing factor
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57. Spectroscopic Evidence of Tertiary Structural Differences Between Insulin Molecules in Fibrils
    Malthe Møhl Schack, Kevin Dahl, Thomas Rades, Minna Groenning, John F. Carpenter · 2019 · Journal of Pharmaceutical Sciences
58. Characterization of Insulin Dimers by Top-Down Mass Spectrometry
    Simon K. Gammelgaard, Steffen Bjørn Petersen, Kim F. Haselmann, Peter Kresten Nielsen · 2020 · Journal of the American Society for Mass Spectrometry
59. Effect of charged mutation on aggregation of a pentapeptide: Insights from molecular dynamics simulations
    R. Prabakaran, Puneet Rawat, Nobuaki Yasuo, Masakazu Sekijima, Sandeep Kumar, M. Michael Gromiha · 2021 · Proteins Structure Function and Bioinformatics
60. Immunogenicity of sarilumab and impact on safety and efficacy in Japanese patients with rheumatoid arthritis: analysis of two Phase 3 randomised clinical trials
    Yoshiya Tanaka, Toshiya Takahashi, Mariko Sumi, OWEN R. HAGINO, Hubert van Hoogstraten, Christine R. Xu, Naoto Kato, Hideto Kameda · 2021 · Modern Rheumatology
61. Immunogenicity of Therapeutic Proteins
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62. Modeling the behavior of monoclonal antibodies on hydrophobic interaction chromatography resins
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63. 2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS ( PART 3A – Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
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64. Molecular Variants Characterization in Protein Therapeutics Development
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65. Application of Affinity-Capture Self-Interaction Nanoparticle Spectroscopy in Predicting Protein Stability, Especially for Co-Formulated Antibodies
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67. Global Analysis of Aggregation Profiles of Three Kinds of Immuno-Oncology mAb Drug Products Using Flow Cytometry
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68. Assessment of innate immune response modulating impurities (IIRMI) in synthetic peptide drugs (liraglutide)
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69. Preclinical immunogenicity testing using anti-drug antibody analysis of GX-G3, Fc-fused recombinant human granulocyte colony-stimulating factor, in rat and monkey models
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70. Biopharmaceutical Informatics: Applications of Computation in Biologic Drug Development
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71. Pharmacokinetic/pharmacodynamic modeling of therapeutic antibodies in oncology: current advances and future perspectives
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72. Application of Mechanistic Pharmacokinetic–Pharmacodynamic Modeling toward the Development of Biologics
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73. Preclinical Immunogenicity Risk Assessement of Biotherapeutics
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74. Fifty-Eight Years and Counting: High-Impact Publishing in Computational Pharmaceutical Sciences and Mechanism-Based Modeling
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75. A Comparison of the Oligosaccharide Structures of Antithrombin Derived from Plasma and Recombinant Using POTELLIGENT® Technology
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77. Quartz Crystal Microbalance as a Predictive Tool for Drug-Material of Construction Interactions in Intravenous Protein Drug Administration
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78. Bioengineering of an elastase inhibitor from Caesalpinia echinata (Brazil wood) seeds
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80. ‘Lower anti-drug antibodies with etanercept biosimilar: can Ctrough explain the differences?‘
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81. In vitro prediction of the immunogenicity of therapeutic proteins: state of the art and current challenges and perspectives
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85. Conference Report: Bioanalysis-Related Highlights from the 2011 AAPS National Biotechnology Conference
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87. Immunogenicity of Therapeutic Proteins
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99. A New Approach to Assess mAb Aggregation
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100. QL0902, a proposed etanercept biosimilar: pharmacokinetic and immunogenicity profile to its reference product in healthy Chinese male subjects
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