Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Lunches in UK early years education and care settings: cross-sectional analysis of food processing, provision and intake.

Research square·2026
Same author

From 3-Tier to adaptive immunogenicity testing strategies: recommendations from the European Bioanalysis Forum.

Bioanalysis·2026
Same author

Progress and promise of pharmacodynamic biomarkers: novel strategies and assay considerations in drug development.

Bioanalysis·2026
Same author

Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products.

The AAPS journal·2026
Same author

A Data-driven Stepwise Approach to Cross Validation of Clinical Anti-Drug Antibody (ADA) Assays.

The AAPS journal·2026
Same author

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)).

Bioanalysis·2026

Related Experiment Video

Updated: Aug 23, 2025

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
07:52

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

8.9K

Anti-drug Antibody Sample Testing and Reporting Harmonization.

Darshana Jani1, Robin Marsden2, Michele Gunsior3

  • 1Bioanalytical and Molecular Assays, Moderna, Cambridge, Massachusetts, USA. Darshana.jani@modernatx.com.

The AAPS Journal
|October 28, 2022
PubMed
Summary
This summary is machine-generated.

Harmonized reporting guidelines for bioanalytical immunogenicity studies, specifically anti-drug antibody (ADA) results, are needed. This work provides recommendations and a template for consistent reporting to aid regulatory review.

Keywords:
Anti-drug antibodies (ADA)Bioanalytical report (BAR)Clinical Study Report (CSR)ImmunogenicityIn-study cut pointReport harmonizationThe Integrated Summary of Immunogenicity (ISI)

More Related Videos

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate
10:05

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Published on: January 17, 2018

36.1K
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.7K

Related Experiment Videos

Last Updated: Aug 23, 2025

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
07:52

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

8.9K
Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate
10:05

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Published on: January 17, 2018

36.1K
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.7K

Area of Science:

  • Bioanalytical science
  • Immunogenicity testing
  • Drug development

Background:

  • A need exists for standardized bioanalytical immunogenicity study reporting.
  • Current reporting practices create gaps in communication and regulatory review.
  • Harmonization is crucial for industry and health authorities.

Purpose of the Study:

  • To establish harmonized recommendations for reporting bioanalytical immunogenicity study results.
  • To develop a submission template for documenting anti-drug antibody (ADA) assay findings.
  • To address key bioanalytical reporting gaps in immunogenicity assessments.

Main Methods:

  • Cross-industry group formation to establish recommendations.
  • Development of a template for bioanalytical reports (BAR).
  • Focus on reporting clinical ADA assay results using ligand-binding assay technologies.

Main Results:

  • Recommendations for essential BAR elements are provided.
  • A suggested structure for the ADA BAR template is included.
  • Focus on content and presentation of bioanalytical ADA sample analysis reports.

Conclusions:

  • Harmonized reporting facilitates communication of immunogenicity findings.
  • Standardized templates aid expedient review by health authorities.
  • This publication provides a framework for consistent ADA bioanalytical reporting.