Publications by authors named "Carol Gleason"

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Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.
Ian B Harvey, Shannon D Chilewski, Devyani Bhosale, Sarah E Tobia, Christopher Gray, Carol Gleason

Anal Chem· April 2024

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Bioanalytical Methods for Characterization of CAR-T Cellular Kinetics: Comparison of PCR Assays and Matrices.
Madhan Masilamani, Vibha Jawa, Yanshan Dai, Romita Das, Alice Park, Carol Gleason

Clin Pharmacol Ther· September 2023

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Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum.
Yanshan Dai, Huijin Dong, Carol Gleason, Johanna Mora, Gerry Kolaitis

AAPS J· April 2023

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Anti-drug Antibody Validation Testing and Reporting Harmonization.
Heather Myler, João Pedras-Vasconcelos, Kelli Phillips, Charles Scott Hottenstein, Paul Chamberlain, Carol Gleason

AAPS J· December 2021

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Thymic Lymphomas in a 6-Month rasH2-Tg Mouse Carcinogenicity Study With the RORγt Inverse Agonist, BMS-986251.
Helen G Haggerty, Jean G Sathish, Carol R Gleason, Muthafar Al-Haddawi, Thomas A Brodie

Toxicol Sci· August 2021

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A bridging immunogenicity assay for anti-cabiralizumab antibodies: overcoming the low assay cut point and drug tolerance challenges.
Long Yuan, Carol R Gleason, Dennis Stocker, Li Li, Jim X Shen

Bioanalysis· March 2021

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Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.
Enaksha R Wickremsinhe, Qin C Ji, Carol R Gleason, Melanie Anderson, Brian P Booth

AAPS J· October 2020

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Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.
Renuka Pillutla, Boris Gorovits, Carol Gleason, Jorge Quiroz, David Christopher

Bioanalysis· June 2020

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Evaluation of correlation between bioanalytical methods.
Carol R Gleason, Qin C Ji, Enaksha R Wickremsinhe

Bioanalysis· March 2020

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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, John Allinson, Shashi Amur, Carol Gleason

Bioanalysis· December 2019

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Bead-extraction and heat-dissociation (BEHD): A novel way to overcome drug and matrix interference in immunogenicity testing.
Weifeng Xu, Michael Sank, Jennifer Cummings, Stephen Carl, Marina Juhel, Carol Gleason

J Immunol Methods· November 2018

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Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab.
Weifeng Xu, Jennifer Cummings, Michael Sank, Marina Juhel, Xuefeng Li, Carol Gleason

Bioanalysis· August 2018

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A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples.
Uma Kavita, Jia Duo, Sean M Crawford, Rong Liu, Joan Valcin, Carol Gleason

J Immunol Methods· September 2017

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Evaluation of cardiac function in unrestrained dogs and monkeys using left ventricular dP/dt.
Lewis V Buchanan, William A Warner, Susan R Arthur, Carol R Gleason, Geoff Lewen

J Pharmacol Toxicol Methods· May 2017

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Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform.
Rong Liu, Brian Hoffpauir, Shannon D Chilewski, Janice Gamberdella, Uma Kavita, Carol Gleason

AAPS J· January 2017

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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Jan Welink, Eric Fluhler, Nicola Hughes, Mark Arnold, Fabio Garofolo, Carol Gleason

Bioanalysis· September 2016

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Development and Validation of Electrochemiluminescence Assays to Measure Free and Total sSLAMF7 in Human Serum in the Absence and Presence of Elotuzumab.
Jennifer Postelnek, Robert J Neely, Michael D Robbins, Carol R Gleason, Jon E Peterson

AAPS J· July 2016

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Impact of menstruation on select hematology and clinical chemistry variables in cynomolgus macaques.
Christopher J Perigard, M Cecilia M Parrula, Matthew H Larkin, Carol R Gleason

Vet Clin Pathol· June 2016

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Recommendations for the development and validation of confirmatory anti-drug antibody assays.
Darshana Jani, Robin Marsden, Alvydas Mikulskis, Carol Gleason, Thomas Klem

Bioanalysis· April 2016

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Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients.
Heather Myler, Matthew W Hruska, Subasree Srinivasan, Elizabeth Cooney, George Kong, Carol Gleason

Bioanalysis· February 2016

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Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
Darshana Jani, John Allinson, Flora Berisha, Kyra J Cowan, Viswanath Devanarayan, Carol Gleason

AAPS J· January 2016

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Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.
Yan G Ni, Xiling Yuan, John A Newitt, Jon E Peterson, Carol R Gleason

AAPS J· July 2015

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Development and validation of an LC-MS/MS assay for the quantitation of a PEGylated anti-CD28 domain antibody in human serum: overcoming interference from antidrug antibodies and soluble target.
Chao Gong, Jianing Zeng, Billy Akinsanya, Hao Jiang, Johanna Mora, Carol Gleason

Bioanalysis· September 2014

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Addressing matrix effects in ligand-binding assays through the use of new reagents and technology.
Shannon D Chilewski, Johanna R Mora, Carol Gleason, Binodh DeSilva

Bioanalysis· April 2014

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Fit-for-purpose bioanalytical cross-validation for LC-MS/MS assays in clinical studies.
Xiaohui Xu, Qin C Ji, Mohammed Jemal, Carol Gleason, Jim X Shen

Bioanalysis· January 2013

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