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Evaluation of Selectivity and Specificity of a Ligand Binding Assay for Macromolecules: An Underestimated Challenge
Wednesday, November 14
7:00 am – 8:15 am
Sunrise Session
ACPE #073-999-07-520-l04
Over the last ten years there has been a steady increase in the number of macromolecular therapeutic candidates in the drug development pipeline. Consequently, ligand binding assays (LBA) have carved a niche in the bioanalytical arena supporting the drug development programs in the GLP environment. There have been many programs at various forums in the AAPS conferences addressing challenges related to the validation of LBA in general. However, selectivity and specificity evaluation remains an underestimated challenge that needs to be addressed adequately. Selectivity demonstrates the degree to which a method measures the target analyte in the presence of other materials present in the matrix. Whereas, the specificity is a measure of an antibody’s ability to bind the analyte of interest, especially in the presence of structurally similar compounds or other potential cross-reactants that may be present in the study samples. These two parameters must be evaluated far in advance before undertaking any pre-study validation of an LBA. Effect of different matrix components from various populations of interest including the heterophilic antibodies, rheumatoid factors, endogenous analytes, may pose an insurmountable challenge in the development and validation of LBA for macromolecule. This sunrise session will address various strategies for determination of selectivity and specificity of the assays. This should be taken as a pre-requisite exercise for the development of any validatable LBA for large-molecule therapeutics. Target audience – CROs, Students and Scientists in academia, & pharmaceutical companies providing bioanalytical support for large molecule – drug development programs.
Moderator
Masood U. Khan, Ph.D.
Covance Laboratories, Inc.
Immunoassay Interference by Matrix Hepterophilic Immunoglobulins: Causes and Concerns
Proveen Dass, Ph.D.
Covance Laboratories, Inc.
Selectivity & Specificity of a Ligand-binding Assay: A Case Study
Bonita Rup, Ph.D.
Wyeth Pharmaceuticals