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Updated: Dec 23, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program.

Johanna R Mora¹, Joleen T White², Shannon D Chilewski¹

¹Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.

|April 29, 2020

Summary

This summary is machine-generated.

Comparing immunogenicity methods requires careful consideration, especially when changes occur mid-program. Defining comparability limits is crucial for pooling data across different assays during clinical development.

Keywords:

immunogenicity life-cycle management limits of comparability method comparison method transfer pooled immunogenicity

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Area of Science:

Biologics
Immunology
Clinical Trials

Background:

Assessing the immunogenicity of biologic drugs is critical for clinical safety and efficacy.
Changes in immunogenicity assay methods during a clinical program necessitate robust comparison strategies.
Ensuring data integrity and comparability across different assay versions is paramount for regulatory submissions.

Purpose of the Study:

To outline and evaluate diverse approaches for comparing immunogenicity methods during clinical development.
To provide practical insights for situations requiring method changes or the use of non-comparable assays.

Main Methods:

Presentation of five distinct case studies illustrating different comparison strategies.
Case studies include small sample size comparisons, full sample re-analysis, and design of experiments for assay comparability.
Exploration of selectivity approaches as alternatives to incurred sample re-analysis.

Main Results:

Demonstrated utility of various methods, including those with limited sample sizes and comprehensive re-analysis.
Showcased the design of experiments to establish data pooling limits for non-comparable assays.
Highlighted the successful application of selectivity approaches as an alternative to incurred samples.

Conclusions:

Establishing clear limits of comparability is essential when pooling data across different immunogenicity methods.
The presented case studies offer valuable guidance for navigating method changes in immunogenicity assessments.
Strategic planning and appropriate methodologies ensure reliable data for regulatory decision-making.