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Viruses
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September 28, 2021
Clinical Characterization and Genomic Analysis of Samples from COVID-19 Breakthrough Infections during the Second Wave among the Various States of India
Nivedita Gupta, Harmanmeet Kaur, Pragya Dhruv Yadav, et al.
Bioanalysis
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, et al.
Bioanalysis
|
February 3, 2021
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 (<u>Part 3</u> - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, et al.
Bioanalysis
|
February 23, 2024
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
Johanna Mora, Rachel Palmer, Leslie Wagner, 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
|
January 6, 2026
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 (<u>PART 3A</u> - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
Omar Tounekti, Sophie Shubow, Sarah Wassmer, 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.
The Lancet Regional Health. Southeast Asia
|
June 15, 2026
Pneumococcal meningitis among hospitalised children after introduction of pneumococcal conjugate vaccine in India: a sentinel hospital surveillance (2019-2022)
Girish Kumar Chethrapilly Purushothaman, Prabu Rajkumar, Boopathi Kangusamy, et al.
Science Robotics
|
April 15, 2026
A careful examination of large behavior models for multitask dexterous manipulation
Jose Barreiros, Andrew Beaulieu, Aditya Bhat, et al.
Page
of 35
Search research articles
Search
Showing results (331-340 of 341) with videos related to
Sort By:
Page
of 35
Viruses
|
September 28, 2021
Clinical Characterization and Genomic Analysis of Samples from COVID-19 Breakthrough Infections during the Second Wave among the Various States of India
Nivedita Gupta, Harmanmeet Kaur, Pragya Dhruv Yadav, et al.
Bioanalysis
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, et al.
Bioanalysis
|
February 3, 2021
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 (<u>Part 3</u> - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, et al.
Bioanalysis
|
February 23, 2024
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
Johanna Mora, Rachel Palmer, Leslie Wagner, 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
|
January 6, 2026
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 (<u>PART 3A</u> - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
Omar Tounekti, Sophie Shubow, Sarah Wassmer, 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.
The Lancet Regional Health. Southeast Asia
|
June 15, 2026
Pneumococcal meningitis among hospitalised children after introduction of pneumococcal conjugate vaccine in India: a sentinel hospital surveillance (2019-2022)
Girish Kumar Chethrapilly Purushothaman, Prabu Rajkumar, Boopathi Kangusamy, et al.
Science Robotics
|
April 15, 2026
A careful examination of large behavior models for multitask dexterous manipulation
Jose Barreiros, Andrew Beaulieu, Aditya Bhat, et al.
Page
of 35