Partridge Michael A - Bioanalytical Sciences, Regeneron Pharmaceuticals Inc

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Immunogenicity of Dupilumab in Adult and Pediatric Patients with Atopic Dermatitis

Frontiers in immunology (2024): 1466372-1466372

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Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development

John D. Davis, Marcal Bravo Padros,Daniela J. Conrado,Samit Ganguly, Xiaowen Guan,Hazem E. Hassan,Anasuya Hazra,Susan C. Irvin,Priya Jayachandran,Matthew P. Kosloski,Kuan-Ju Lin,Kamalika Mukherjee,Anne Paccaly,Apostolos Papachristos,Michael A. Partridge,Saileta Prabhu,Jennifer Visich, Erik S. Welf, Xiaoying Xu,An Zhao, Min Zhu

CLINICAL PHARMACOLOGY & THERAPEUTICSno. 3 (2024): 422-439

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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 (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunoge..

Johanna Mora,Rachel Palmer,Leslie Wagner,Bonnie Wu,Michael Partridge, Meena,Ivo Sonderegger,John Smeraglia,Nicoletta Bivi,Naveen Dakappagari, Sandra Diebold,Fabio Garofolo,Christine Grimaldi,Warren Kalina,John Kamerud,Sumit Kar,Jean-Claude Marshall, Christian Mayer,Andrew Melton, Keith Merdek, Katrina Nolan,Serge Picard,Weiping Shao,Jessica Seitzer,Yoichi Tanaka,Omar Tounekti,Adam Vigil,Karl Walravens,Joshua Xu,Weifeng Xu,Yuanxin Xu,Lin Yang, Liang Zhu,Daniela Verthelyi,Robert J. Kubiak,Kelly Coble,Swati Gupta,Mohsen Rajabi Abhari,Susan Richards, Yuan Song,Martin Ullmann,Boris Calderon,Isabelle Cludts,George R. Gunn,Shalini Gupta,Akiko Ishii-Watabe,Mohanraj Manangeeswaran,Kimberly Maxfield,Fred Mccush, Christine O'Day, Kate Peng,Johann Poetzl,Michele Rasamoelisolo,Ola M. Saad,Kara Scheibner,Sophie Shubow, Sam Song,Seth Thacker

BIOANALYSIS（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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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 (part 3-Recommendations on Gene Therapy, Cell Therapy, Vacci..

Luying Pan,Johanna Mora,Karl Walravens,Leslie Wagner,Shirley Hopper,Lina Loo, David Bettoun, Sarah Bond,Francis Dessy,Sean Downing,Fabio Garofolo,Soumi Gupta,Neil Henderson,Chad Irwin,Akiko Ishii-Watabe,Sumit Kar,Vibha Jawa,Julie Joseph,Ludovic Malvaux,Jean-Claude Marshall,Jessica McDevitt, Susovan Mohapatra,Jessica Seitzer,Justin Smith,Therese Solstad,Hiroshi Sugimoto,Omar Tounekti,Bonnie Wu,Yuling Wu,Yuanxin Xu,Joshua Xu,Takenori Yamamoto,Lin Yang,Albert Torri,Susan Kirshner,Kimberly Maxfield,Joao Pedras Vasconcelos,Mohsen Rajabi Abhari,Daniela Verthelyi,Eric Brodsky,Montserrat Carrasco-Triguero,John Kamerud,Matthew Andisik,Daniel Baltrukonis,Nicoletta Bivi,Isabelle Cludts,Kelly Coble,Boris Gorovits,George R. Gunn,Swati Gupta,Anders Holm Millner,Alison Joyce,Robert J. Kubiak,Seema Kumar,Karen Liao,Mohanraj Manangeeswaran,Michael Partridge,Samuel Pine,Johann Poetzl,Manoj Rajadhyaksha,Michele Rasamoelisolo,Susan Richards, Yuan Song,Steven Swanson,Seth Thacker,Meenu Wadhwa, Andreas Wolf,Lucia Zhang, Lin Zhou

Bioanalysisno. 14 (2023): 773-814

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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,Mohamed Hassanein,Susan C. Irvin,Jihua Chen, Xiao Meng, Hong Yan,Albert Torri,Giane Sumner,Matthew D. Andisik,Anne Paccaly,Michael A. Partridge

The Journal of Clinical Pharmacologyno. 1 (2023): 125-136

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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, Emily Nunez, Kristina Kameron,Keilah Fenech, Jacqueline Rodriguez,Albert Torri,Jihua Chen,Giane Sumner,Michael A. Partridge

The AAPS Journal（2023）

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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 (Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherape..

Sarah Hersey,Steve Keller,Joel Mathews,Lindsay King,Abbas Bandukwala,Flora Berisha,Mary Birchler,Joe Bower,Valerie Clausen,Jose Duarte,Fabio Garofolo,Shirley Hopper,Sumit Kar,Omar Mabrouk,Jean-Claude Marshall,Kristina McGuire,Michael Naughton,Yoshiro Saito, Imelda Schuhmann,Gizette Sperinde,Priscila Teixeira,Alessandra Vitaliti,Yow-Ming Wang,Richard Wnek,Yan Zhang, Sue Spitz,Vilma Decman,Steven Eck,Jose Estevam,Polina Goihberg,Enrique Gómez Alcaide,Christèle Gonneau,Michael Nathan Hedrick,Gregory Hopkins,Fabian Junker,Sandra Nuti,Ulrike Sommer,Nathan Standifer,Chad Stevens,Erin Stevens,Carrie Hendricks,Meenu Wadhwa,Albert Torri,Mark Ma,Shannon Harris,Seema Kumar,Michael A Partridge,Teresa Caiazzo,Shannon Chilewski,Isabelle Cludts,Kelly Coble,Boris Gorovits,Christine Grimaldi,Gregor Jordan,John Kamerud,Beth Leary,Meina Liang, Hanjo Lim,Andrew Mayer,Ellen O'Connor,Nisha Palackal,Johann Poetzl,Sandra Prior,Mohsen Rajabi Abhari,Natasha Savoie,Catherine Soo,Mark Ware,Bonnie Wu,Yang Xu,Tong-Yuan Yang,Jad Zoghbi

Bioanalysisno. 10 (2022): 627-692

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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 (Part 2-Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulate..

Sarah Hersey,Steve Keller,Joel Mathews,Lindsay King,Abbas Bandukwala,Flora Berisha,Mary Birchler,Joe Bower,Valerie Clausen,Jose Duarte,Fabio Garofolo,Shirley Hopper,Sumit Kar,Omar Mabrouk,Jean-Claude Marshall,Kristina McGuire,Michael Naughton,Yoshiro Saito, Imelda Schuhmann,Gizette Sperinde,Priscila Teixeira,Alessandra Vitaliti,Yow-Ming Wang,Richard Wnek,Yan Zhang, Sue Spitz,Vilma Decman,Steven Eck,Jose Estevam,Polina Goihberg,Enrique Gomez Alcaide,Christele Gonneau,Michael Nathan Hedrick,Gregory Hopkins,Fabian Junker,Sandra Nuti,Ulrike Sommer,Nathan Standifer,Chad Stevens,Erin Stevens,Carrie Hendricks,Meenu Wadhwa,Albert Torri,Mark Ma,Shannon Harris,Seema Kumar,Michael A. Partridge,Teresa Caiazzo,Shannon Chilewski,Isabelle Cludts,Kelly Coble,Boris Gorovits,Christine Grimaldi,Gregor Jordan,John Kamerud,Beth Leary,Meina Liang, Hanjo Lim,Andrew Mayer,Ellen O'Connor,Nisha Palackal,Johann Poetzl,Sandra Prior,Mohsen Rajabi Abhari,Natasha Savoie,Catherine Soo,Mark Ware,Bonnie Wu,Yang Xu,Tong-Yuan Yang,Jad Zoghbi

BIOANALYSIS（2022）

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Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay

Partridge Michael A.,Chen Jihua,Karayusuf Elif Kabuloglu,Sirimanne Thanoja,Stefan Colin,Lai Ching Ha,Gathani Meghna,DeStefano Lisa, Rozanski Michal,McAfee Sean,Rajadhyaksha Manoj,Andisik Matthew D.,Torri Albert,Sumner Giane

The AAPS journal（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

Starcevic Manning Marta,Hassanein Mohamed,Partridge Michael A.,Jawa Vibha,Mora Johanna,Ryman Josiah,Barker Breann, Braithwaite Christian,Carleton Kevin, Hay Laura,Hottenstein Charles,Kubiak Robert J.,Devanarayan Viswanath

The AAPS Journal（2022）

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