M
Michael Moxness
Researcher at Amgen
Publications - 20
Citations - 1402
Michael Moxness is an academic researcher from Amgen. The author has contributed to research in topics: Monoclonal antibody & Antibody. The author has an hindex of 12, co-authored 20 publications receiving 1305 citations.
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Journal ArticleDOI
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
Gopi Shankar,Viswanath Devanarayan,Lakshmi Amaravadi,Yu Chen Barrett,Ronald R. Bowsher,Deborah Finco-Kent,Michele Fiscella,Boris Gorovits,Susan Kirschner,Michael Moxness,Thomas Parish,Valerie Quarmby,Holly W. Smith,Wendell C. Smith,Linda Zuckerman,Eugen Koren +15 more
TL;DR: The authors recommend experimental and statistical approaches for the validation of immunoassay performance characteristics, intended to foster a more unified approach to antibody testing across the biopharmaceutical industry.
Journal ArticleDOI
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Eugen Koren,Holly W. Smith,Elizabeth Shores,Gopi Shankar,Deborah Finco-Kent,Bonita Rup,Yuchen Barrett,Viswanath Devanarayan,Boris Gorovits,Shalini Gupta,Thomas Parish,Valerie Quarmby,Michael Moxness,Steven J. Swanson,Gary Taniguchi,Linda Zuckerman,Christopher Stebbins,Anthony Mire-Sluis +17 more
TL;DR: This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors to foster a more unified approach to antibody testing across the biopharmaceutical industry.
Journal ArticleDOI
Six-month continuous intraputamenal infusion toxicity study of recombinant methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF) in rhesus monkeys.
David N. Hovland,Robert B. Boyd,Mark T. Butt,Jeffery A. Engelhardt,Michael Moxness,Mark Ma,Maurice Emery,Nadia B. Ernst,Randall P. Reed,Jillynne R. Zeller,Don M. Gash,Donna M. Masterman,Beth M. Potter,Mary Ellen Cosenza,Ruth M. Lightfoot +14 more
TL;DR: The data support an association with r-metHuGDNF treatment with reduced food consumption and body weight and meningeal thickening underlying the medulla oblongata and/or overlying various spinal cord segments at 30 and 100 μg/day.
Journal ArticleDOI
Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies.
Michael Moxness,Suzanna M. Tatarewicz,Dohan Weeraratne,Nancy Murakami,Danika Wullner,Dan Mytych,Vibha Jawa,Eugen Koren,Steven J. Swanson +8 more
TL;DR: This “bridging” assay format eliminated the need for species–specific secondary antibodies and provided assay consistency in different serum matrices as a drug product moves from preclinical to clinical development.
Journal ArticleDOI
Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics.
Marisa K. Joubert,Meghana Deshpande,Jane Yang,Helen M Reynolds,Christine J. Bryson,Mark H. Fogg,Matthew P. Baker,Jonathan Herskovitz,Theresa J. Goletz,Lei Zhou,Michael Moxness,Gregory C. Flynn,Linda O. Narhi,Vibha Jawa +13 more
TL;DR: An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool for predicting the potential relative immunogenicity of biotherapeutic attributes and was used successfully to assess similarity between multiple lots of the same mAb, both from the same manufacturer and from different manufacturers.