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Summary of confirmation cut point discussions
Holly W Smith1, Michael Moxness, Robin Marsden
1Investigative Toxicology, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
The AAPS Journal
|March 8, 2011
Summary
Attendees of the AAPS NBC Immunogenicity Workshop discussed best practices for immunogenicity assays. They aimed to establish appropriate methods for determining confirmatory cut points in assay development.
Area of Science:
- Biopharmaceutical development
- Immunogenicity assay validation
Background:
- Current recommendations for immunogenicity assays are found in white papers and guidance documents.
- Industry practices for determining confirmatory cut points vary.
- Concerns exist regarding the biological and statistical appropriateness of current methods.
Purpose of the Study:
- To discuss current practices for determining confirmatory cut points in immunogenicity assays.
- To address concerns regarding the biological and statistical approaches for assay validation.
- To provide recommendations for establishing appropriate confirmatory cut points.
Main Methods:
- Subgroup meeting of AAPS NBC Immunogenicity Workshop attendees.
- Discussion of existing white papers and guidance documents.
- Review and critique of current industry practices.
Main Results:
- Identified areas of consensus and disagreement on assay validation approaches.
- Highlighted the need for standardized methods for confirmatory cut point determination.
- Outlined key considerations for biological and statistical appropriateness.
Conclusions:
- Recommendations were formulated to improve the consistency and reliability of immunogenicity assays.
- The discussions aimed to resolve concerns and provide guidance for assay development.
- Further standardization in determining confirmatory cut points is warranted.
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