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Scientific Reports
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March 11, 2018
Glyco-engineered Long Acting FGF21 Variant with Optimal Pharmaceutical and Pharmacokinetic Properties to Enable Weekly to Twice Monthly Subcutaneous Dosing
Yan Weng, Tetsuya Ishino, Annette Sievers, et al.
Bioanalysis
|
December 11, 2019
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, et al.
Bioanalysis
|
December 24, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity)
Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, et al.
Bioanalysis
|
January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)
Nicoletta Bivi, Danielle Graham, Laura Joglekar, 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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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.
Bioanalysis
|
January 29, 2026
2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))
Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, et al.
Bioanalysis
|
August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, Steve Keller, James Huleatt, et al.
Bioanalysis
|
January 29, 2021
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (<u>Part 2A</u> - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation <u>Part 2B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Susan Spitz, Yan Zhang, Sally Fischer, et al.
Analytical Biochemistry
|
January 10, 2009
A global benchmark study using affinity-based biosensors
Rebecca L Rich, Giuseppe A Papalia, Peter J Flynn, et al.
Page
of 3
Search research articles
Search
Showing results (21-30 of 29) with videos related to
Sort By:
Page
of 3
You have reached the last page of results.
This site can display upto 29 results.
Scientific Reports
|
March 11, 2018
Glyco-engineered Long Acting FGF21 Variant with Optimal Pharmaceutical and Pharmacokinetic Properties to Enable Weekly to Twice Monthly Subcutaneous Dosing
Yan Weng, Tetsuya Ishino, Annette Sievers, et al.
Bioanalysis
|
December 11, 2019
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, et al.
Bioanalysis
|
December 24, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity)
Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, et al.
Bioanalysis
|
January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)
Nicoletta Bivi, Danielle Graham, Laura Joglekar, 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.
Bioanalysis
|
January 29, 2026
2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))
Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, et al.
Bioanalysis
|
August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, Steve Keller, James Huleatt, et al.
Bioanalysis
|
January 29, 2021
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (<u>Part 2A</u> - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation <u>Part 2B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Susan Spitz, Yan Zhang, Sally Fischer, et al.
Analytical Biochemistry
|
January 10, 2009
A global benchmark study using affinity-based biosensors
Rebecca L Rich, Giuseppe A Papalia, Peter J Flynn, et al.
Page
of 3