460 results on '"Watabe, Akiko"'
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2. Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles
3. Specific peptide conjugation to a therapeutic antibody leads to enhanced therapeutic potency and thermal stability by reduced Fc dynamics
4. Intracellular polyamine depletion induces N-linked galactosylation of the monoclonal antibody produced by CHO DP-12 cells
5. Target-independent Immune-cell Activation by Aggregates of T Cell-redirecting Bispecific Antibodies
6. Key role of P230 in the hinge region on the IgG architecture and function
7. Development of a penetratin-conjugated stapled peptide that inhibits Wnt/β-catenin signaling
8. A Collaborative Study on the Classification of Silicone Oil Droplets and Protein Particles Using Flow Imaging Method
9. Subvisible Particles Derived by Dropping Stress Enhance Anti-PEG Antibody Production and Clearance of PEGylated Proteins in Mice
10. Quantitative Evaluation of Insoluble Particulate Matters in Therapeutic Protein Injections Using Light Obscuration and Flow Imaging Methods
11. Fcγ Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates
12. Characterization of Aggregated Antibody-Silicone Oil Complexes: From Perspectives of Morphology, 3D Image, and Fcγ Receptor Activation
13. Development of anti-drug monoclonal antibody panels against adalimumab and infliximab
14. Fcγ Receptor Activation by Human Monoclonal Antibody Aggregates
15. Exploring the Influence of Parenting Styles on Development of Perfectionism in a Reward and Punishment Computer-Based Learning Task among College Students
16. In-depth site-specific O-Glycosylation analysis of therapeutic Fc-fusion protein by electron-transfer/higher-energy collisional dissociation mass spectrometry
17. Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium
18. Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method
19. Relationship between the lipidome profile and disease activity in patients with rheumatoid arthritis
20. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
21. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
22. Pharmacokinetics of Biopharmaceuticals: Their Critical Role in Molecular Design
23. A Cell-Based Reporter Assay Measuring the Activation of Fc Gamma Receptors Induced by Therapeutic Monoclonal Antibodies
24. Antibody feedback contributes to facilitating the development of Omicron-reactive memory B cells in SARS-CoV-2 mRNA vaccinees
25. Investigation of Foreign Particles in Moderna COVID-19 Vaccine
26. Quality Evaluation of Therapeutic Antibodies by Multi-attribute Method
27. Technical Innovation of Manufacturing and Quality Control of Biologics to Strengthen the Basis for New Biologics Development Leading to International Contribution
28. What Is an Antibody Test? Characteristics of Antibodies against SARS-CoV-2 and Their Tests
29. FcγRIIIa-158V/F polymorphism affects the performance of FcγRIIIa-related bioassay
30. Biophysical Characterization of the Contribution of the Fab Region to the IgG-FcγRIIIa Interaction
31. 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A– Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B- Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
32. Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics
33. Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan
34. Fcγ Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates
35. Characterization of anti-SARS-CoV-2 monoclonal antibodies focusing on antigen binding, neutralization, and FcγR activation via formation of immune complex.
36. Genetic Polymorphisme of FCGRT Encoding FcRn in a Japanese Population and Their Functional Analysis
37. Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD
38. Author response: Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD
39. Antibody Tests: Characteristics of Antibodies Involved in Immune System Against Infection and Their Testing Methods
40. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)
41. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
42. Genetic polymorphisms of FCGR2A encoding Fcγ receptor IIa in a Japanese population and functional analysis of the L273P variant
43. The Novel Compounds That Activate Farnesoid X Receptor: the Diversity of Their Effects on Gene Expression
44. Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan
45. Biophysical Characterization of the Contribution of the Fab Region to the IgG-FcγRIIIa Interaction
46. 2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)
47. Efficacy and safety of i.v. methylprednisolone pulse therapy for vitiligo: A retrospective study of 58 therapy experiences for 33 vitiligo patients
48. 2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
49. Bioanalysis of therapeutic monoclonal antibody by peptide adsorption-controlled LC–MS
50. Successful treatment of syringotropic CD8+ mycosis fungoides accompanied by hypohidrosis with vorinostat and retinoids
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