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Bioanalysis
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November 19, 2010
Unwanted immunogenicity: lessons learned and future challenges
Meenu Wadhwa, Robin Thorpe
Bioanalysis
|
November 8, 2019
Harmonization and standardization of immunogenicity assessment of biotherapeutic products
Meenu Wadhwa, Robin Thorpe
Bioanalysis
|
November 14, 2024
Harmonization of Vaccine Ligand Binding Assays Validation
Francis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis
|
June 22, 2026
Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and Transfer
Jeroen Stoop, James Huleatt, Luc Gagnon, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)
Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis
|
January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis
|
May 17, 2022
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 (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)
Lina Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis
|
June 20, 2024
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (<u>PART 2</u> - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, et al.
Bioanalysis
|
May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (<u>Part 2</u> - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)
Sarah Hersey, Steve Keller, Joel Mathews, et al.
Bioanalysis
|
August 1, 2023
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 (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan, Johanna Mora, Karl Walravens, et al.
Page
of 2
Search research articles
Search
Showing results (1-10 of 14) with videos related to
Sort By:
Page
of 2
Bioanalysis
|
November 19, 2010
Unwanted immunogenicity: lessons learned and future challenges
Meenu Wadhwa, Robin Thorpe
Bioanalysis
|
November 8, 2019
Harmonization and standardization of immunogenicity assessment of biotherapeutic products
Meenu Wadhwa, Robin Thorpe
Bioanalysis
|
November 14, 2024
Harmonization of Vaccine Ligand Binding Assays Validation
Francis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis
|
June 22, 2026
Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and Transfer
Jeroen Stoop, James Huleatt, Luc Gagnon, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)
Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis
|
January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis
|
May 17, 2022
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 (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)
Lina Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis
|
June 20, 2024
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (<u>PART 2</u> - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, et al.
Bioanalysis
|
May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (<u>Part 2</u> - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)
Sarah Hersey, Steve Keller, Joel Mathews, et al.
Bioanalysis
|
August 1, 2023
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 (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan, Johanna Mora, Karl Walravens, et al.
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