Publications by authors named "Mark Qian"

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Heterogeneous and evolving epitope landscape of clinical anti-drug antibodies against multidomain biotherapeutic: a case study of TAK-186.
Ruoxuan Sun, Janey Ronxhi, Mark G Qian, Zheng Zha, Bin Li

MAbs· December 2025

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Rapid and Wash-Free Anti-Drug Antibody Assay Enabled by a Complementary Nanoluciferase Biosensor.
Ruoxuan Sun, Mark G Qian, Xiaobin Zhang

Anal Chem· July 2025

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Two-Cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues.
Yipei Zhang, Mark G Qian, Xuemei Yang, Linlin Dong

Anal Chem· July 2025

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Differential Protein Precipitation-Based GalNAc-siRNA Sample Preparation with LC/MS Method Development Workflow in Plasma.
Youngjae Kim, Ting Ting Zhang, Hiroshi Sugimoto, Mark G Qian, Linlin Dong

Anal Chem· June 2025

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2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).
John Wojcik, Timothy Sikorski, Jian Wang, Yue Huang, Hiroshi Sugimoto, Mark Qian

Bioanalysis· March 2025

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Feasibility of a direct binding electrochemiluminescence assay to detect anti-drug antibodies against therapeutic peptides.
Ruoxuan Sun, Janey Ronxhi, Xuemei Yang, Mark G Qian, Xiaobin Zhang

J Pharm Biomed Anal· February 2025

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A Multi-Component Reaction Peptide Augmenting the Anti-Aging Benefits of Non-Ablative Laser Procedure.
Kun Mark Qian, Michael Kaminer, I-Chien Liao, Janet Wangari-Olivero, Jyotsna Paturi, Qian Zheng

J Drugs Dermatol· February 2025

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Exploring the diagnostic potential of miRNA signatures in the Fabry disease serum: A comparative study of automated and manual sample isolations.
Josephine Y Fang, Saravanan Ayyadurai, Alyssa F Pybus, Hiroshi Sugimoto, Mark G Qian

PLoS One· October 2024

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Quantifying LAGA mutated mouse IgG2a monoclonal antibody with a rapid pepsin digestion enabled immunoaffinity LC/MS/MS assay.
Linlin Dong, Susan Chen, Konstantin Piatkov, Dong Wei, Mark G Qian

MAbs· July 2024

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The application of a multi-component reaction peptide as a model regenerative active to enhance skin wound-healing postlaser procedure in a double-blinded placebo-controlled clinical trial.
I-Chien Liao, Chunyan He, Xue Lucia Liu, Rebecca Barresi-Thornton, Janet Wangari-Olivero, Mark Kun Qian, Qian Zheng

J Cosmet Dermatol· March 2024

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T and B cell epitope analysis for the immunogenicity evaluation and mitigation of antibody-based therapeutics.
Ruoxuan Sun, Mark G Qian, Xiaobin Zhang

MAbs· March 2024

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Mark Qian

Bioanalysis· August 2023

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Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome.
Peter M Franchi, Nadia Kulagina, Anna Ilinskaya, Brian Hoffpauir, Mark G Qian

AAPS J· June 2023

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Development of a Highly Sensitive Hybrid LC/MS Assay for the Quantitative Measurement of CTLA-4 in Human T Cells.
Dong Wei, Kristin L Horton, John Chen, Linlin Dong, Susan Chen, Mark G Qian

Molecules· April 2023

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Targeted Mass Spectrometry-Based Approach for the Determination of Intrinsic Internalization Kinetics of Cell-Surface Membrane Protein Targets.
Dhimankrishna Ghosh, Hiroshi Sugimoto, Janice Y Lee, Mark Qian

Anal Chem· July 2021

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An Automated Multicycle Immunoaffinity Enrichment Approach Developed for Sensitive Mouse IgG1 Antibody Drug Analysis in Mouse Plasma Using LC/MS/MS.
Linlin Dong, Nicole Bebrin, Konstantin Piatkov, Kojo Abdul-Hadi, Shinji Iwasaki, Mark G Qian

Anal Chem· April 2021

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Discovery of TAK-981, a First-in-Class Inhibitor of SUMO-Activating Enzyme for the Treatment of Cancer.
Steven P Langston, Stephen Grossman, Dylan England, Roushan Afroze, Neil Bence, Mark Qian

J Med Chem· March 2021

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Insights on Droplet Digital PCR-Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy.
Hiroshi Sugimoto, Susan Chen, Jean-Pierre Minembe, Johara Chouitar, Xingyue He, Mark G Qian

AAPS J· March 2021

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Correction to: Insights on Droplet Digital PCR-Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy.
Hiroshi Sugimoto, Susan Chen, Jean-Pierre Minembe, Johara Chouitar, Xingyue He, Mark G Qian

AAPS J· March 2021

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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Hendrik Neubert, Stephen C Alley, Anita Lee, Wenying Jian, Michael Buonarati, Mark Qian

Bioanalysis· February 2021

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Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-derived Xenografts.
Adnan O Abu-Yousif, Donna Cvet, Melissa Gallery, Bret M Bannerman, Michelle L Ganno, Mark G Qian

Mol Cancer Ther· October 2020

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Hybrid LC-MS as a powerful tool for supporting protein bioanalysis in gene and cell therapies.
Dong Wei, Youngjae Kim, Hiroshi Sugimoto, Linlin Dong, Mark G Qian

Bioanalysis· July 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, Mark Qian

Bioanalysis· June 2020

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Pharmacokinetic Characterization and Tissue Distribution of Fusion Protein Therapeutics by Orthogonal Bioanalytical Assays and Minimal PBPK Modeling.
Hiroshi Sugimoto, Susan Chen, Mark G Qian

Molecules· January 2020

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An LC/MS based method to quantify DNA adduct in tumor and organ tissues.
Chao Li, Linlin Dong, Afrand Kamali, Hiroshi Sugimoto, Kojo Abdul-Hadi, Mark G Qian

Anal Biochem· March 2019

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