Evidence map›Paper›PMID 38992280›Full record

ArticleThe AAPS journal2024

Neutralizing Antibody Sample Testing and Report Harmonization.

Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao and 25 more

Erratum issuedAbstract read
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

35 authors.

Darshana JaniBioanalytical and Molecular Assays, Moderna, 325 Binney Street, Cambridge, Massachusetts, USA. darshana.jani@modernatx.com.ORCID 0000-0002-6329-7759
Michele Gunsior *Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA.
Robin Marsden *Revelation Biosciences, San Diego, California, USA.
Kyra J CowanDrug Metabolism & Pharmacokinetics, New Biological Entities, Merck KGaA, Darmstadt, Germany.
Susan C IrvinBioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
Laura Schild HayBioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.
Bethany WardBioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.
Luke ArmstrongBioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA.
Mitra AzadehBioanalytical and Biomarker Development, Ultragenyx Pharmaceutical, Inc, Novato, California, USA.
Liching CaoBiomarker and BioAnalytical Sciences, Sangamo Therapeutics, Brisbane, California, USA.
Rebecca CarmeanBioanalytical Lab, PPD Clinical Research Business, Thermo Fisher Scientific, Richmond, Virginia, USA.
Jason DelCarpiniBioanalytical Sciences, Moderna, Cambridge, Massachusetts, USA.
Sanjay L DholakiyaNon-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
Amanda HaysScientific Office, BioAgilytix Labs, Durham, North Carolina, USA.
Sarah HosbackResearch and Clinical Bioanalytics, CSL, Melbourne, Australia.
Zheng HuTranslational Safety & Bioanalytical Science, Amgen Inc, Thousand Oaks, California, USA.
Nadia KulaginaPharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.
Seema KumarDMPK and Bioanalysis, Pioneering Medicines at Flagship Pioneering, Cambridge, Massachusetts, USA.
Ching Ha LaiBioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
Marit LichtfussResearch and Clinical Bioanalytics, CSL, Melbourne, Australia.
Hsing-Yin LiuJanssen Research & Development LLC, Spring House, Montgomery County, Pennsylvania, USA.
Susana LiuClinical Pharmacology, Biologics & Immunogenicity Clinical Assay Group, Pfizer Inc, Kirkland, Quebec, Canada.
Reza MozaffariBioanalysis, Immunogenicity & Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA.
Luying PanTakeda Development Center Americas Inc, Cambridge, Massachusetts, USA.
Jason PennucciBioanalytical Sciences, Moderna, Cambridge, Massachusetts, USA.
Marie-Eve PoupartImmunology, Charles River Laboratories, Senneville, Quebec, Canada.
Gurleen SainiDrug Metabolism & Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.
Veerle SnoeckTranslational Biomarkers and Bioanalysis, UCB Biopharma SRL, 1420, Braine-L'Alleud, Belgium.
Kristine StoreyPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc, Rahway, New Jersey, USA.
Amy TurnerPharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.
Inna VainshteinDiscovery and Translational Research, Exelixis, Alameda, California, USA.
Daniela VerthelyiOffice of Pharmaceutical Quality Research, Division IV, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Iwona WalaTranslational Safety and Bioanalytical Sciences, Amgen, Thousand Oaks, California, USA.
Lili YangTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Lin YangBioanalytical Sciences, REGENXBIO Inc, Rockville, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Antibodies, NeutralizingHumansAntibodies, Neutralizingbioanalytical reportimmunogenicitymulti-functional therapeuticsneutralizing antibodytemplate

Identifiers

PMID38992280

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.