Neutralizing Antibody Sample Testing and Report Harmonization.

Antibodies, Neutralizing / immunology Humans
bioanalytical report immunogenicity multi-functional therapeutics neutralizing antibody template

Journal

The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209

Informations de publication

Date de publication:
12 Jul 2024
Historique:
received: 19 04 2024
accepted: 27 06 2024
medline: 12 7 2024
pubmed: 12 7 2024
entrez: 11 7 2024
Statut: epublish

Résumé

Immunogenicity testing and characterization is an important part of understanding the immune response to administration of a protein therapeutic. Neutralizing antibody (NAb) assays are used to characterize a positive anti-drug antibody (ADA) response. Harmonization of reporting of NAb assay performance and results enables efficient communication and expedient review by industry and health authorities. Herein, a cross-industry group of NAb assay experts have harmonized NAb assay reporting recommendations and provided a bioanalytical report (BAR) submission editable template developed to facilitate agency filings. This document addresses key bioanalytical reporting gaps and provides a report structure for documenting clinical NAb assay performance and results. This publication focuses on the content and presentation of the NAb sample analysis report including essential elements such as the method, critical reagents and equipment, data analysis, study samples, and results. The interpretation of immunogenicity data, including the evaluation of the impact of NAb on safety, exposure, and efficacy, is out of scope of this publication.

Identifiants

DOI: 10.1208/s12248-024-00955-1 PMID: 38992280
pubmed: 38992280
doi: 10.1208/s12248-024-00955-1
pii: 10.1208/s12248-024-00955-1
doi:

Substances chimiques

Antibodies, Neutralizing 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

80

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Darshana Jani (D)

Bioanalytical and Molecular Assays, Moderna, 325 Binney Street, Cambridge, Massachusetts, USA. darshana.jani@modernatx.com.
ORCID: 0000-0002-6329-7759

Michele Gunsior (M)

Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA.

Robin Marsden (R)

Revelation Biosciences, San Diego, California, USA.

Kyra J Cowan (KJ)

Drug Metabolism & Pharmacokinetics, New Biological Entities, Merck KGaA, Darmstadt, Germany.

Susan C Irvin (SC)

Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.

Laura Schild Hay (LS)

Bioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.

Bethany Ward (B)

Bioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.

Luke Armstrong (L)

Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA.

Mitra Azadeh (M)

Bioanalytical and Biomarker Development, Ultragenyx Pharmaceutical, Inc, Novato, California, USA.

Liching Cao (L)

Biomarker and BioAnalytical Sciences, Sangamo Therapeutics, Brisbane, California, USA.

Rebecca Carmean (R)

Bioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.

Jason DelCarpini (J)

Bioanalytical Sciences, Moderna, Cambridge, Massachusetts, USA.

Sanjay L Dholakiya (SL)

Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.

Amanda Hays (A)

Scientific Office, BioAgilytix Labs, Durham, North Carolina, USA.

Sarah Hosback (S)

Research and Clinical Bioanalytics, CSL, Melbourne, Australia.

Zheng Hu (Z)

Translational Safety & Bioanalytical Science, Amgen Inc, Thousand Oaks, California, USA.

Nadia Kulagina (N)

Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.

Seema Kumar (S)

DMPK and Bioanalysis, Pioneering Medicines at Flagship Pioneering, Cambridge, Massachusetts, USA.

Ching Ha Lai (CH)

Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.

Marit Lichtfuss (M)

Research and Clinical Bioanalytics, CSL, Melbourne, Australia.

Hsing-Yin Liu (HY)

Janssen Research & Development LLC, Spring House, Montgomery County, Pennsylvania, USA.

Susana Liu (S)

Clinical Pharmacology, Biologics & Immunogenicity Clinical Assay Group, Pfizer Inc, Kirkland, Quebec, Canada.

Reza Mozaffari (R)

Bioanalysis, Immunogenicity & Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA.

Luying Pan (L)

Takeda Development Center Americas Inc, Cambridge, Massachusetts, USA.

Jason Pennucci (J)

Bioanalytical Sciences, Moderna, Cambridge, Massachusetts, USA.

Marie-Eve Poupart (ME)

Immunology, Charles River Laboratories, Senneville, Quebec, Canada.

Gurleen Saini (G)

Drug Metabolism & Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.

Veerle Snoeck (V)

Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, 1420, Braine-L'Alleud, Belgium.

Kristine Storey (K)

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc, Rahway, New Jersey, USA.

Amy Turner (A)

Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.

Inna Vainshtein (I)

Discovery and Translational Research, Exelixis, Alameda, California, USA.

Daniela Verthelyi (D)

Office of Pharmaceutical Quality Research, Division IV, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Iwona Wala (I)

Translational Safety and Bioanalytical Sciences, Amgen, Thousand Oaks, California, USA.

Lili Yang (L)

Takeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.

Lin Yang (L)

Bioanalytical Sciences, REGENXBIO Inc, Rockville, Maryland, USA.

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Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps neutralisants › Neutralizing Antibody Sample Testing and...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Neutralizing Antibody Sample Testing and...