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Genome Biology
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December 24, 2021
Author Correction: The SEQC2 epigenomics quality control (EpiQC) study
Jonathan Foox, Jessica Nordlund, Claudia Lalancette, et al.
Nature Biotechnology
|
September 7, 2023
Multi-omics data integration using ratio-based quantitative profiling with Quartet reference materials
Yuanting Zheng, Yaqing Liu, Jingcheng Yang, 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.
Scientific Reports
|
March 26, 2024
Extend the benchmarking indel set by manual review using the individual cell line sequencing data from the Sequencing Quality Control 2 (SEQC2) project
Binsheng Gong, Dan Li, Yifan Zhang, 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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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.
Genome Biology
|
June 26, 2015
Comparison of RNA-seq and microarray-based models for clinical endpoint prediction
Wenqian Zhang, Ying Yu, Falk Hertwig, et al.
Bioanalysis
|
August 31, 2023
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Matt Szapacs, Wenying Jian, Daniel Spellman, et al.
Genome Biology
|
April 17, 2021
A verified genomic reference sample for assessing performance of cancer panels detecting small variants of low allele frequency
Wendell Jones, Binsheng Gong, Natalia Novoradovskaya, et al.
Nature Biotechnology
|
April 13, 2021
Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology
Ira W Deveson, Binsheng Gong, Kevin Lai, et al.
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Search research articles
Search
Showing results (151-160 of 163) with videos related to
Sort By:
Page
of 17
Genome Biology
|
December 24, 2021
Author Correction: The SEQC2 epigenomics quality control (EpiQC) study
Jonathan Foox, Jessica Nordlund, Claudia Lalancette, et al.
Nature Biotechnology
|
September 7, 2023
Multi-omics data integration using ratio-based quantitative profiling with Quartet reference materials
Yuanting Zheng, Yaqing Liu, Jingcheng Yang, 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.
Scientific Reports
|
March 26, 2024
Extend the benchmarking indel set by manual review using the individual cell line sequencing data from the Sequencing Quality Control 2 (SEQC2) project
Binsheng Gong, Dan Li, Yifan Zhang, 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.
Genome Biology
|
June 26, 2015
Comparison of RNA-seq and microarray-based models for clinical endpoint prediction
Wenqian Zhang, Ying Yu, Falk Hertwig, et al.
Bioanalysis
|
August 31, 2023
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Matt Szapacs, Wenying Jian, Daniel Spellman, et al.
Genome Biology
|
April 17, 2021
A verified genomic reference sample for assessing performance of cancer panels detecting small variants of low allele frequency
Wendell Jones, Binsheng Gong, Natalia Novoradovskaya, et al.
Nature Biotechnology
|
April 13, 2021
Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology
Ira W Deveson, Binsheng Gong, Kevin Lai, et al.
Page
of 17