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Method Validation Software Development for Immunogenicity Assays

Method Validation Software Development for Immunogenicity Assays

The identification of immunogenicity assays that would best characterize innate and adaptive immune responses to candidate vaccines is an ongoing goal of NIAID sponsored projects, and one of the functions of the CFAR Immunology Core under the oversight of the Duke CFAR Central Quality Assurance Program, directed by Dr. Sarzotti-Kelsoe. The development of new immune monitoring assays proceeds from the research and development stage, to optimization, qualification and finally validation of such assays in compliance to regulatory requirements.

Neutralizing antibody, binding antibody, bead array, Antibody Dependent Cellular Cytotoxicity, Biolayer Interferometry, Luminex platforms, automation, as well as (ongoing) pharmacokinetics (PK) and anti-drug assays (ADA) have been qualified and/or validated under the direct oversight of Dr. Sarzotti-Kelsoe. Validating an assay consists of evaluating the applicability of the parameters described in the ICH Q2 (R1) and FDA guidelines for relevance to the assay and its intended use: accuracy, precision, limit of detection, limit of quantitation, specificity, linearity and range, ruggedness/robustness, and system suitability. Acceptance criteria for each parameter need to be statistically pre-defined in the assay validation. There is a definite need to streamline the process for planning validation experiments, including the number of samples to be tested, the number of repeat experiments, the type of statistical evaluation to verify each of the validation parameters.


The candidate student will play a crucial role in developing a statistical software program to assist Dr. Sarzotti-Kelsoe’s on method validation based on ICH-Q2(R1), FDA Bioanalitical Method Validation for Industry 2018 and Good Clinical Laboratory Standard (GCLP) guidelines standards.