Publications by authors named "Alison Joyce"

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Development of a novel anti-PEG antibody assay enabling investigation of potential immunogenicity triggered by the PEG moiety of biotherapeutics.
Lisa Dyleski, Ying Wang, Elena Seletskaia, Lee Walus, Teresa Caiazzo, Alison Joyce

J Immunol Methods· September 2025

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Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip® Columns for Sample Pretreatment in an Immunogenicity Assay.
Michael Luong, Minlei Zhang, Ihor Djura, Ying Wang, Alison Joyce

AAPS J· June 2025

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2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Nicoletta Bivi, Danielle Graham, Laura Joglekar, Kristina McGuire, Jeroen Stoop, Alison Joyce

Bioanalysis· February 2025

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Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents.
Glenn T Miller, Teresa M Caiazzo, Alison Joyce

J Immunol Methods· October 2024

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Alison Joyce

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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 ( - 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, Leslie Wagner, Shirley Hopper, Alison Joyce

Bioanalysis· July 2023

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Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation.
Alison Joyce, Christopher Shea, Zhiping You, Boris Gorovits, Christopher Lepsy

AAPS J· November 2022

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An Assessment of LRRK2 Serine 935 Phosphorylation in Human Peripheral Blood Mononuclear Cells in Idiopathic Parkinson's Disease and G2019S LRRK2 Cohorts.
Shalini Padmanabhan, Thomas A Lanz, Donal Gorman, Michele Wolfe, Alison Joyce

J Parkinsons Dis· July 2021

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Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies.
Teresa M Caiazzo, Christopher M Shea, Alison P Joyce

Bioanalysis· May 2021

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Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling.
Ying Wang, Sarah J Crowell, Alison Joyce, Lisa Dyleski, Dean Messing

Pharm Res· May 2021

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Alison Joyce

Bioanalysis· March 2021

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GDF-15 Neutralization Alleviates Platinum-Based Chemotherapy-Induced Emesis, Anorexia, and Weight Loss in Mice and Nonhuman Primates.
Danna M Breen, Hanna Kim, Donald Bennett, Roberto A Calle, Susie Collins, Alison Joyce

Cell Metab· December 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, Alison Joyce, Alison Joyce

Bioanalysis· December 2019

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Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling.
Liang Zhu, Ying Wang, Alison Joyce, Ihor Djura, Boris Gorovits

Pharm Res· October 2019

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Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody.
Yuhong Xiang, Chuenlei Parng, Katrina Olson, Elena Seletskaia, Boris Gorovits, Alison Joyce

AAPS J· March 2019

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Glyco-engineered Long Acting FGF21 Variant with Optimal Pharmaceutical and Pharmacokinetic Properties to Enable Weekly to Twice Monthly Subcutaneous Dosing.
Yan Weng, Tetsuya Ishino, Annette Sievers, Saswata Talukdar, Jeffrey R Chabot, Alison Joyce

Sci Rep· March 2018

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Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies.
Lindsay B Avery, Mengmeng Wang, Mania S Kavosi, Alison Joyce, Jeffrey C Kurz

MAbs· December 2017

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A Multi-site In-depth Evaluation of the Quanterix Simoa from a User's Perspective.
Allison Given Chunyk, Alison Joyce, Saloumeh K Fischer, Mark Dysinger, Alvydas Mikulskis

AAPS J· December 2017

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Preclinical Pharmacokinetics, Pharmacodynamics, Tissue Distribution, and Interspecies Scaling of Recombinant Human Coagulation Factor Xa.
Chuenlei Parng, Victoria Markiewicz, Jianqing Chen, Beth Leary, Nicole Duriga, Alison Joyce

J Pharm Sci· August 2017

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Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform.
Tracey H Clark, Phillip D Yates, Allison Given Chunyk, Alison P Joyce, Aidong Wu

AAPS J· September 2016

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, Laura Salazar-Fontana, Boris Gorovits, Alison Joyce

Bioanalysis· August 2015

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Faster in vivo clearance of human embryonic kidney than Chinese hamster ovary cell derived protein: Role of glycan mediated clearance.
Mengmeng Wang, Tetsuya Ishino, Alison Joyce, Amy Tam, Weili Duan

J Biosci Bioeng· June 2015

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Emerging technologies to increase ligand binding assay sensitivity.
Saloumeh K Fischer, Alison Joyce, Mark Spengler, Tong-Yuan Yang, Yao Zhuang

AAPS J· January 2015

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Comparison of succinimidyl [(125)I]iodobenzoate with iodogen iodination methods to study pharmacokinetics and ADME of biotherapeutics.
Jianqing Chen, Mengmeng Wang, Alison Joyce, David DeFranco, Mania Kavosi

Pharm Res· October 2014

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Challenges in selectivity, specificity and quantitation range of ligand-binding assays: case studies using a microfluidics platform.
Tong-Yuan Yang, David J Uhlinger, Stephen A Ayers, Denise M O'Hara, Alison P Joyce

Bioanalysis· April 2014

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