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The method history report: an adaptable tool for communicating immunogenicity assay development and validation
Kristin Hollister1, Huy T Nguyen1, Jessie L Bishop1
1Eli Lilly & Company, Indianapolis, IN 46285, USA.
Bioanalysis
|November 6, 2020
Summary
A new Method History Report (MHR) can streamline the review of therapeutic protein immunogenicity assay validation history for biologics license applications. This standardized document aids regulatory review and reduces information requests.
Area of Science:
- Biopharmaceutical Development
- Regulatory Science
- Immunology
Background:
- Therapeutic protein development generates extensive immunogenicity assay validation data.
- Reviewing this history within biologics license applications can be challenging for regulators.
- This complexity often leads to numerous information requests during regulatory review.
Purpose of the Study:
- To propose a novel document, the Method History Report (MHR).
- To provide a comprehensive and adaptable template for presenting immunogenicity assay development and validation history.
- To facilitate smoother regulatory review of biologics license applications.
Main Methods:
- Development of a standardized Method History Report (MHR) template.
- Outlining the rationale and general structure for the MHR.
- Demonstrating the flexibility of the MHR for diverse therapeutic programs.
Main Results:
- The MHR offers a structured approach to compiling assay validation history.
- It allows for consistent presentation while accommodating program-specific needs.
- The report aims to proactively address potential regulatory questions.
Conclusions:
- Adoption of the MHR can significantly improve the efficiency of regulatory reviews.
- The MHR supports comprehensive documentation of immunogenicity assay lifecycle.
- This approach is recommended for biologics license application activities.
