S
Steven J. Swanson
Researcher at Amgen
Publications - 61
Citations - 3442
Steven J. Swanson is an academic researcher from Amgen. The author has contributed to research in topics: Immunogenicity & Antibody. The author has an hindex of 29, co-authored 61 publications receiving 3257 citations. Previous affiliations of Steven J. Swanson include Schering-Plough & Walter Reed Army Medical Center.
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Journal ArticleDOI
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
Anthony Mire-Sluis,Yu Chen Barrett,Viswanath Devanarayan,Eugene Koren,Hank Liu,Mauricio Maia,Thomas Parish,George Scott,Gopi Shankar,Elizabeth Shores,Steven J. Swanson,Gary Taniguchi,Daniel Wierda,Linda Zuckerman +13 more
TL;DR: While the main focus of this document is assay design considerations, it provides scientific focus and background to the various assay performance parameters necessary for developing a valid assay.
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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.
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Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
Gopi Shankar,Steven Arkin,L. Cocea,Viswanath Devanarayan,Susan Kirshner,A. Kromminga,Valerie Quarmby,Susan M. Richards,Christian Schneider,Meena Subramanyam,Steven J. Swanson,Daniela Verthelyi,S. Yim +12 more
TL;DR: Understanding the incidence, kinetics and magnitude of anti-drug antibody (ADA), its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated withBiologic drugs.
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Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.
Shalini Gupta,Stephen R. Indelicato,Vijay Jethwa,Thomas T. Kawabata,Marian Kelley,Anthony Mire-Sluis,Susan M. Richards,Bonita Rup,Elizabeth Shores,Steven J. Swanson,Eric Wakshull +10 more
TL;DR: This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies.
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An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen
TL;DR: This protocol describes a bridging ELISA that uses a covalently coupled high density antigen surface combined with an acid dissociation step to allow for antibody detection in the presence of antigen in human serum.