Journal ArticleDOI
Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.
Shalini Gupta,Viswanath Devanarayan,Deborah Finco,George R. Gunn,Susan Kirshner,Susan M. Richards,Bonita Rup,An Song,Meena Subramanyam +8 more
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TLDR
Recommendations on best practices for the validation of cell-based NAb assay and suggested validation parameters based on the experience of the authors are provided.About:
This article is published in Journal of Pharmaceutical and Biomedical Analysis.The article was published on 2011-07-15. It has received 117 citations till now. The article focuses on the topics: Neutralizing antibody.read more
Citations
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Phase 3 Study of Reslizumab in Patients With Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts
TL;DR: Rlizumab was well tolerated in patients with inadequately controlled asthma, with fewer overall adverse events compared with placebo and Clinically meaningful effects on lung function and symptom control were not seen in patients unselected for baseline eosinophils.
Journal ArticleDOI
Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy
TL;DR: These recommendations are based on risk assessment and include the determination of ADA content (concentration/titer), affinity, immunoglobulin isotype/subtype, and neutralization capacity.
Journal ArticleDOI
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.
Journal ArticleDOI
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
TL;DR: An overview of the methods used for assessing immunogenicity of biotherapeutic products (BTPs) and the most important considerations in interpreting results in the context of regulatory overview of these products is provided.
Journal ArticleDOI
Determination of anti-adeno-associated virus vector neutralizing antibody titer with an in vitro reporter system.
Amine Meliani,Christian Leborgne,Sabrina Triffault,Laurence Jeanson-Leh,Philippe Veron,Federico Mingozzi +5 more
TL;DR: An improved in vitro, cell-based assay for the determination of NAb titer in serum or plasma samples is described and can be validated to support clinical development of gene therapy products based on AAV vectors.
References
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Journal ArticleDOI
Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Binodh DeSilva,Wendell C. Smith,Russell Weiner,Marian Kelley,JoMarie Smolec,Ben Lee,Masood Khan,Richard Tacey,Howard Hill,Abbie Celniker +9 more
TL;DR: Recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules are made.
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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.
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
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
TL;DR: A general strategy to broadly assign immunogenicity risk levels to biological drug products is proposed, and a risk level–based 'fit-for-purpose' bioanalytical schemes for the investigations of treatment-related ADAs in clinical and nonclinical studies are presented.