Publications by authors named "Manoj Rajadhyaksha"

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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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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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, Manoj Rajadhyaksha

Bioanalysis· July 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, Manoj Rajadhyaksha

AAPS J· July 2022

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Manoj Rajadhyaksha

Bioanalysis· June 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, Manoj Rajadhyaksha

AAPS J· June 2022

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The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis.
Mohamed A Kamal, Pavel Kovalenko, Matthew P Kosloski, Kamal Srinivasan, Yi Zhang, Manoj Rajadhyaksha

Clin Pharmacol Ther· November 2021

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REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics.
Mohamed A Kamal, Robert Dingman, Claire Q Wang, Ching-Ha Lai, Manoj Rajadhyaksha

Clin Transl Sci· November 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, Manoj Rajadhyaksha

Bioanalysis· March 2021

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Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study.
Frédéric Vanhoutte, Su Liang, Marcella Ruddy, An Zhao, Tiera Drewery, Manoj Rajadhyaksha

J Clin Pharmacol· November 2020

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Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study.
Mette Deleuran, Diamant Thaçi, Lisa A Beck, Marjolein de Bruin-Weller, Andrew Blauvelt, Manoj Rajadhyaksha

J Am Acad Dermatol· February 2020

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Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial.
Margitta Worm, Eric L Simpson, Diamant Thaçi, Robert Bissonnette, Jean-Philippe Lacour, Manoj Rajadhyaksha

JAMA Dermatol· February 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, Manoj Rajadhyaksha

Bioanalysis· December 2019

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Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies.
Zhandong Don Zhong, Adrienne Clements-Egan, Boris Gorovits, Mauricio Maia, Giane Sumner, Manoj Rajadhyaksha

AAPS J· November 2017

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Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.
Matthew Andisik, Lisa DeStefano, Colin Stefan, Meghna Gathani, Kevin Laurino, Manoj Rajadhyaksha

Bioanalysis· March 2016

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Pre-existing Antibody: Biotherapeutic Modality-Based Review.
Boris Gorovits, Adrienne Clements-Egan, Mary Birchler, Meina Liang, Heather Myler, Manoj Rajadhyaksha

AAPS J· March 2016

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Mechanistic investigation of the preclinical pharmacokinetics and interspecies scaling of PF-05231023, a fibroblast growth factor 21-antibody protein conjugate.
Craig Giragossian, Chandra Vage, Jun Li, Kathleen Pelletier, Nicole Piché-Nicholas, Manoj Rajadhyaksha

Drug Metab Dispos· June 2015

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2012 AAPS National Biotech Conference Open Forum: a perspective on the current state of immunogenicity prediction and risk management.
Manoj Rajadhyaksha, Meena Subramanyam, Bonnie Rup

AAPS J· October 2013

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Pre-existing biotherapeutic-reactive antibodies: survey results within the American Association of Pharmaceutical Scientists.
Li Xue, Michele Fiscella, Manoj Rajadhyaksha, Jaya Goyal, Claire Holland

AAPS J· July 2013

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Current advances in delivery of biotherapeutics across the blood-brain barrier.
Manoj Rajadhyaksha, Tracey Boyden, Jennifer Liras, Ayman El-Kattan, Joanne Brodfuehrer

Curr Drug Discov Technol· June 2011

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Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.
Dong Geng, Gopi Shankar, Allen Schantz, Manoj Rajadhyaksha, Hugh Davis

J Pharm Biomed Anal· September 2005

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