4.3 Article

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)

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Biochemistry & Molecular Biology

Identification of preexisting adaptive immunity to Cas9 proteins in humans

Carsten T. Charlesworth et al.

NATURE MEDICINE (2019)

Article Biochemical Research Methods

Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection

Uwe Wessels et al.

BIOANALYSIS (2018)

Article Biochemical Research Methods

Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments

Robert J. Kubiak et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2018)

Review Biotechnology & Applied Microbiology

Unraveling the Complex Story of Immune Responses to AAV Vectors Trial After Trial

Celine Vandamme et al.

HUMAN GENE THERAPY (2017)

Article Immunology

Guidelines for the use of flow cytometry and cell sorting in immunological studies

Andrea Cossarizza et al.

EUROPEAN JOURNAL OF IMMUNOLOGY (2017)

Review Pharmacology & Pharmacy

Pre-existing Antibody: Biotherapeutic Modality-Based Review

Boris Gorovits et al.

AAPS JOURNAL (2016)

Review Biochemistry & Molecular Biology

On the Dependency of Cellular Protein Levels on mRNA Abundance

Yansheng Liu et al.

Review Medical Laboratory Technology

Recommendations for the development and validation of flow cytometry-based receptor occupancy assays

Cherie L. Green et al.

CYTOMETRY PART B-CLINICAL CYTOMETRY (2016)

Review Medical Laboratory Technology

Role of receptor occupancy assays by flow cytometry in drug development

Jennifer J. Stewart et al.

CYTOMETRY PART B-CLINICAL CYTOMETRY (2016)

Article Immunology

Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

Robert J. Kubiak et al.

JOURNAL OF IMMUNOLOGY RESEARCH (2016)

Article Hematology

The evolution of guidelines for the validation of flow cytometric methods

L. Du et al.

INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY (2015)

Review Biochemical Research Methods

Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development

Lynette Brown et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2015)

Article Biochemical Research Methods

A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays

Jad Zoghbi et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2015)

Article Pharmacology & Pharmacy

Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay

Meiyu Shen et al.

JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2015)

Review Biochemical Research Methods

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

Boris Gorovits et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2014)

Article Biochemical Research Methods

Stability of anti-immunotherapeutic antibodies in frozen human serum samples

Lydia Michaut et al.

BIOANALYSIS (2014)

Article Medical Laboratory Technology

Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part V - Assay Performance Criteria

Brent Wood et al.

CYTOMETRY PART B-CLINICAL CYTOMETRY (2013)

Article Chemistry, Analytical

Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays

Robert J. Kubiak et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2013)

Article Biochemical Research Methods

2013 White Paper on recent issues in bioanalysis: 'hybrid' - the best of LBA and LCMS

Lauren Stevenson et al.

BIOANALYSIS (2013)

Article Biochemical Research Methods

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

Binodh DeSilva et al.

BIOANALYSIS (2012)

Review Pharmacology & Pharmacy

Interactions of formulation excipients with proteins in solution and in the dried state

Satoshi Ohtake et al.

ADVANCED DRUG DELIVERY REVIEWS (2011)

Article Biochemical Research Methods

Recommendations for the validation of flow cytometric testing during drug development: I instrumentation

Cherie L. Green et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2011)

Article Biochemical Research Methods

Recommendations for the validation of flow cytometric testing during drug development: II assays

Denise M. O'Hara et al.

JOURNAL OF IMMUNOLOGICAL METHODS (2011)

Article Medical Laboratory Technology

The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments

Stephen A. Bustin et al.

CLINICAL CHEMISTRY (2009)

Article Chemistry, Multidisciplinary

Fit-for-purpose method development and validation for successful biomarker measurement

JW Lee et al.

PHARMACEUTICAL RESEARCH (2006)