Bioanalysis Zone

Considerations for evaluation of accuracy, parallelism and reagent lot-to-lot variability in single and multiplex biomarker ligand binding assays




Biomarker analysis has become a common practice by most pharmaceutical companies to support PK/PD modeling, but the reliability of outcomes is heavily influenced by the rigor that the bioanalytical team puts into understanding the limitations of the assay. The goal of this presentation was to review the concept of parallelism and relative accuracy for biomarker studies, using various case studies to increase awareness of the bioanalytical challenges and considerations as they pertain to these, as well as to reagent lot-to-lot variability.

What will you learn?

  • How, through case studies, bioanalytical labs have overcome the key challenges of executing biomarker studies
  • The requirements for parallelism to assess the suitability of using a recombinant protein calibrator in a simple buffer matrix for measurement of a sample
  • Why and how “relative accuracy” should be considered during the assay validation, and when values are assigned to samples used for quality controls during the sample analysis
  • How to control lot-to-lot variability of critical reagents and commercial immunoassay kits, particularly for multiplex assays

Who may this interest?

  • Scientists, Outsourcing, Upper Management


Afshin-Safavi-BZsiteAfshin Safavi, PhD
Co-Founder and Chief Scientific Officer

Dr Afshin Safavi, is a veteran biochemist with extensive experience in establishing and leading bioanalytical teams in support of the development of biological products in preclinical and clinical trial laboratories. Prior to founding BioAgilytix, he was the Director of Ligand Binding and Immunoassay at AAIPharma. At Talecris BioTherapeutics, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International. Dr Safavi is considered an expert in the area of immunoassay and biomarker with a wide working knowledge of various platforms.

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