Development and Evaluation of Ultrasensitive, Fit for Purpose Biomarker Assays using the Singulex® Erenna® Platform
Learning Objectives
- Understand the regulatory Fit for Purpose validation requirements for protein biomarkers
- Understand the technical challenges associated with the analysis of low abundance protein biomarkers
- Learn about the application of ultrasensitive immunoassays during the development of biotherapeutics
Webinar Description
Protein biomarkers provide insights into the safety, efficacy and target population for drugs in development. Typically, immunoassays have a lower limit of quantitation (LLOQ) in the 1-10 pm / mL range, and our ability to routinely and robustly measure biomarker levels below that range means that potentially valuable protein biomarker signatures go undetected and unused. The Singulex® Erenna® platform uses a digital ELISA approach that can detect proteins down to the femtogram / mL levels, providing an unprecedented opportunity to utilize ultra-low biomarker concentrations in clinical development. We describe the application of ultrasensitive immunoassays during drug development and present as a case study the development and implementation of assays to Ab42 and IL17F in human plasma. Challenges encountered and approaches taken in the development of the methods will be discussed, as well as comparison of the performance of these assays to corresponding ELISA methods.
Meet the Speakers
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John Kamerud, PhD. Dr. Kamerud is Scientific Director at Eurofins' St Charles, Missouri site, where his role is to serve as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements. He received his PhD (Biochemistry) in 1987 from the University of Minnesota. Dr Kamerud has over 20 years of experience in the development, validation and implementation of immunoassay methods, holding positions with EMD Millipore, Covance Laboratories and Eli Lilly & Comp |
