Publications by authors named "Michael Partridge"

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Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics.
Susan C Irvin, Samit Ganguly, Zhiqiang Wang, Zhongqing Will He, Marguerite Alejandro, Michael A Partridge

AAPS J· October 2025

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Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays.
Michael A Partridge, Lynn Kamen, Bonnie Wu, Helene Solberg, Jim McNally

AAPS J· August 2025

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Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
Sophie Shubow, Michele Gunsior, Amy Rosenberg, Yow-Ming Wang, Tara Altepeter, Michael A Partridge

AAPS J· March 2025

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2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).
Omar Tounekti, Sandra Prior, Sarah Wassmer, Joshua Xu, Adrian Wong, Michael A Partridge

Bioanalysis· February 2025

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Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.
Ching-Ha Lai, Mu Chen, Sasha Fraser, Jessica Wang, Sean McAfee, Michael A Partridge

AAPS J· December 2024

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Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis.
Mohamed A Kamal, Matthew P Kosloski, Ching-Ha Lai, Michael A Partridge, Manoj Rajadhyaksha

Front Immunol· November 2024

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2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge

Bioanalysis· April 2024

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Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development.
John D Davis, Marçal Bravo Padros, Daniela J Conrado, Samit Ganguly, Xiaowen Guan, Michael A Partridge

Clin Pharmacol Ther· March 2024

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Immunogenicity of Cemiplimab: Low Incidence of Antidrug Antibodies and Cut-Point Suitability Across Tumor Types.
Jenny L Valentine, Andrew Dengler, An Zhao, Tiffany Truong, Sean McAfee, Michael A Partridge

J Clin Pharmacol· January 2024

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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, Michael Partridge

Bioanalysis· July 2023

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Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.
John Garlits, Sean McAfee, Jessica-Ann Taylor, Enoch Shum, Qi Yang, Michael A Partridge

AAPS J· April 2023

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Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay.
Michael A Partridge, Jihua Chen, Elif Kabuloglu Karayusuf, Thanoja Sirimanne, Colin Stefan

AAPS J· July 2022

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Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.
Marta Starcevic Manning, Mohamed Hassanein, Michael A Partridge, Vibha Jawa, Johanna Mora

AAPS J· July 2022

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Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy.
Susan C Irvin, Amanda D'Orvilliers, Nicolin Bloch, Kayla Boccio, Jason Pennucci, Michael A Partridge

AAPS J· June 2022

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2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Michael A Partridge

Bioanalysis· May 2022

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Assay pH and critical reagent optimization in measuring concentrations of a monoclonal antibody and its target.
Jihua Chen, Kimberly Kendra, Stacey Shank, Ashique Rafique, George Ehrlich, Michael A Partridge

Bioanalysis· April 2022

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REGEN-COV antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification.
Susan C Irvin, Samit Ganguly, Rachel Weiss, Chinnasamy Elango, Xuefei Zhong, Michael A Partridge

Bioanalysis· December 2021

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Quantitation of reduced IL-33 levels in human serum: mitigating interference from endogenous binding partners.
Joshua Zylstra, Michael A Partridge, Giane Sumner

Bioanalysis· December 2021

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Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays.
Andrew F Dengler, Rachel Weiss, Tiffany Truong, Susan C Irvin, Nidhi Gadhia, Michael A Partridge

AAPS J· October 2021

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Liquid Chromatography-Multiple Reaction Monitoring-Mass Spectrometry Assay for Quantitative Measurement of Therapeutic Antibody Cocktail REGEN-COV Concentrations in COVID-19 Patient Serum.
Xuefei Zhong, Shruti Nayak, Lili Guo, Shivkumar Raidas, Yunlong Zhao, Michael A Partridge

Anal Chem· September 2021

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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Michael Partridge

Bioanalysis· March 2021

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Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry.
Xiaoxiao Huang, Xiaobin Xu, Michael A Partridge, Jihua Chen, Ellen Koehler-Stec

AAPS J· January 2021

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Assessment of clinically relevant immunogenicity for mAbs; are we over reporting ADA?
Mohamed Hassanein, Michael A Partridge, Weiping Shao, Albert Torri

Bioanalysis· September 2020

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Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data.
Michael A Partridge, Elif Kabuloglu Karayusuf, Gary Shyu, Camille Georgaros, Albert Torri

AAPS J· August 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, Michael Partridge

Bioanalysis· December 2019

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