Redefining 3Rs for Safety Toxicology Biomarkers using Automated Nanoliter-scale Immunoassays
This is a recording from April 23, 2014
Biomarker assays in the development of therapeutics are often challenged with limited sample volumes, slow assay development and the need for high quality data to support analysis from discovery to clinical trials. Current immunoassay methods require sample volumes that necessitate pooling samples from multiple mice for testing. Miniaturizing and automating biomarker immunoassays at nanoliter-scale reduces the number of animals required as Gyrolab™ xP workstation uses 4 µL for duplicate analysis and allows for multiple analyses from a single mouse. Please join scientists from Eli Lilly and EMD Millipore as they present the latest developments in safety toxicology biomarkers using the Gyrolab nanoliter-scale immunoassay platform and its’ impact on maximizing sensivity, performance and productivity of biomarker assays in the development of therapeutics.
Introduction to Gyros and Gyrolab automated nanoliter-scale immunoassay platform.
Use of Gyrolab platform for biomarkers
A Timely Little 2-Step: How To Dance Around Lower Affinity Antibodies on Your Gyrolab™xP System
Diane M. Hamlin Investigative Toxicology,Eli Lilly, Indianapolis, IN
The Gyrolab™ system is a valuable immunoassay platform for the rapid development and validation of accurate, precise, robust and transferrable custom-developed assays for novel biomarkers to support early safety and efficacy assessment in preclinical drug development. However, as with other immunoassay platforms that have “wash” steps, lower affinity antibody reagents are not optimal in a standard 3-step Gyros™ Wizard method, causing a loss of assay sensitivity and/or precision. For a custom-developed rat IL1b inflammation biomarker assay, this limitation was overcome by modifying the standard 3-step (“antibody-sandwich”) Gyros™ method to incorporate a preincubation step; resulting in >7-fold increase in assay sensitivity. The modified rat IL1b Gyros™ assay was then successfully transferred and validated at an external laboratory (Contract Research Organization (CRO)). The presentation will also highlight the benefit of using the 3D and 2D images in the Gyros™ software for assay trouble-shooting, optimization of a 2-step method and the use of biological samples to verify antibody selectivity/specificity.
Novel Rat Kidney Injury Biomarker Assays Using a Gyros Nanotechnology Platform
Wei Zheng, M.S. Ph.D., Director, Research & Development, Bioscience, EMD Millipore
Eli Lilly, Investigative Toxicology
Wei Zheng, M.S. Ph.D.
Director, Research & Development
EMD Millipore, Bioscience
Robert A. Durham PhD
Director of Field Applications, North America
Gyros US, Inc.