Related references
Note: Only part of the references are listed.Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint
Seema C. Kumar et al.
AAPS JOURNAL (2017)
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: immunogenicity, biomarkers and PK assays)
Shalini Gupta et al.
BIOANALYSIS (2017)
Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response
Marta Starcevic Manning et al.
BIOANALYSIS (2017)
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)
Hendrik Neubert et al.
BIOANALYSIS (2017)
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1-LCMS: small molecules, peptides and small molecule biomarkers)
Jan Welink et al.
BIOANALYSIS (2017)
Cellular kinetics of CTL019 in relapsed/refractory B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia
Karen Thudium Mueller et al.
BLOOD (2017)
Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material
Kyra J. Cowan et al.
AAPS JOURNAL (2017)
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development
Li Xue et al.
AAPS JOURNAL (2017)
WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products
Ivana Knezevic et al.
ANNALS OF THE NEW YORK ACADEMY OF SCIENCES (2017)
Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points
Viswanath Devanarayan et al.
AAPS JOURNAL (2017)
Evaluation of IgE Antibodies to Omalizumab (Xolair (R)) and Their Potential Correlation to Anaphylaxis
Dana L. Baker et al.
AAPS JOURNAL (2016)
Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers
Mark E. Arnold et al.
AAPS JOURNAL (2016)
Viral vectors as vaccine platforms: from immunogenicity to impact
Katie J. Ewer et al.
CURRENT OPINION IN IMMUNOLOGY (2016)
Receptor occupancy by flow cytometry
Virginia Litwin et al.
CYTOMETRY PART B-CLINICAL CYTOMETRY (2016)
Recommendations for the development and validation of flow cytometry-based receptor occupancy assays
Cherie L. Green et al.
CYTOMETRY PART B-CLINICAL CYTOMETRY (2016)
Role of receptor occupancy assays by flow cytometry in drug development
Jennifer J. Stewart et al.
CYTOMETRY PART B-CLINICAL CYTOMETRY (2016)
Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
Meenu Wadhwa et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2016)
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3-LBA, biomarkers and immunogenicity)
Susan Richards et al.
BIOANALYSIS (2016)
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1-small molecules, peptides and small molecule biomarkers by LCMS)
Eric Yang et al.
BIOANALYSIS (2016)
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2-Hybrid LBA/LCMS and input from regulatory agencies)
An Song et al.
BIOANALYSIS (2016)
Biomarkers, PK and immunogenicity: are we ready for integration?
Lauren F. Stevenson
BIOANALYSIS (2016)
Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays
Robert J. Kubiak et al.
JOURNAL OF IMMUNOLOGY RESEARCH (2016)
Statistical approaches for the determination of cut points in anti-drug antibody bioassays
Frank Schaarschmidt et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2015)
Treatment of CD33-directed Chimeric Antigen Receptor-modified T Cells in One Patient With Relapsed and Refractory Acute Myeloid Leukemia
Quan-shun Wang et al.
MOLECULAR THERAPY (2015)
The quintessence of immunogenicity reporting for biotherapeutics
Gopi Shankar et al.
NATURE BIOTECHNOLOGY (2015)
Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development
Masood U. Khan et al.
BIOANALYSIS (2015)
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2-hybrid LBA/LCMS and input from regulatory agencies)
Brad Ackermann et al.
BIOANALYSIS (2015)
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1-small molecules by LCMS)
Jan Welink et al.
BIOANALYSIS (2015)
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3-LBA, biomarkers and immunogenicity)
Lakshmi Amaravadi et al.
BIOANALYSIS (2015)
Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations
G. Shankar et al.
AAPS JOURNAL (2014)
Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics
Boris Gorovits et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2014)
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1-small molecules by LCMS)
Eric Fluhler et al.
BIOANALYSIS (2014)
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2-hybrid LBA/LCMS, ELN & regulatory agencies' input)
Dawn Dufield et al.
BIOANALYSIS (2014)
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3-LBA and immunogenicity)
Lauren Stevenson et al.
BIOANALYSIS (2014)
Immune responses to AAV vectors: overcoming barriers to successful gene therapy
Federico Mingozzi et al.
BLOOD (2013)
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)
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)
Clinical relevance of serum natalizumab concentration and anti-natalizumab antibodies in multiple sclerosis
Anke Vennegoor et al.
MULTIPLE SCLEROSIS JOURNAL (2013)
Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management
Brian J. Geist et al.
BIOANALYSIS (2013)
2013 White Paper on recent issues in bioanalysis: 'hybrid' - the best of LBA and LCMS
Lauren Stevenson et al.
BIOANALYSIS (2013)
Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy
Narendra Chirmule et al.
AAPS JOURNAL (2012)
NIST/ISAC standardization study: Variability in assignment of intensity values to fluorescence standard beads and in cross calibration of standard beads to hard dyed beads
Robert A. Hoffman et al.
CYTOMETRY PART A (2012)
Development and characterization of a human antibody reference panel against erythropoietin suitable for the standardization of ESA immunogenicity testing
Daniel T. Mytych et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2012)
6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson et al.
BIOANALYSIS (2012)
2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
Binodh DeSilva et al.
BIOANALYSIS (2012)
Recommendations on biomarker bioanalytical method validation by GCC
Richard Hougton et al.
BIOANALYSIS (2012)
Standardizing immunophenotyping for the Human Immunology Project
Holden T. Maecker et al.
NATURE REVIEWS IMMUNOLOGY (2012)
Recommendations for the validation of flow cytometric testing during drug development: II assays
Denise M. O'Hara et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2011)
2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections
Fabio Garofolo et al.
BIOANALYSIS (2011)
Prevalence of Serum IgG and Neutralizing Factors Against Adeno-Associated Virus (AAV) Types 1, 2, 5, 6, 8, and 9 in the Healthy Population: Implications for Gene Therapy Using AAV Vectors
Sylvie Boutin et al.
HUMAN GENE THERAPY (2010)
Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics
Suzanna Tatarewicz et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2010)
Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development
William Nowatzke et al.
BIOANALYSIS (2010)
2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance
Natasha Savoie et al.
BIOANALYSIS (2010)
2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop
Natasha Savoie et al.
BIOANALYSIS (2010)
The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis
Natasha Savoie et al.
BIOANALYSIS (2009)
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
Gopi Shankar et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2008)
An inventory of shedding data from clinical gene therapy trials
Ellen A. M. Schenk-Braat et al.
JOURNAL OF GENE MEDICINE (2007)
Successful transduction of liver in hemophilia by AAV-factor IX and limitations imposed by the host immune response
CS Manno et al.
NATURE MEDICINE (2006)
Fit-for-purpose method development and validation for successful biomarker measurement
JW Lee et al.
PHARMACEUTICAL RESEARCH (2006)
Infectious titer assay for adeno-associated virus vectors with sensitivity sufficient to detect single infectious events
Z Zhen et al.
HUMAN GENE THERAPY (2004)
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
AR Mire-Sluis et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2004)
Share Paper
