Ligand Binding Assays in the 21st Century Laboratory—A Call for Change

Abstract

OVERVIEWIn June 2009, a group of ligand binding assay experts met in Seattle, WA to discuss the need for greater efficiency in bioanalytical laboratories. The central premise was increased utilization of technological innovation will lead to increased quality, throughput, and efficiency. Currently, there are very few laboratories that have reached the ideal or utopian level desired. The biggest challenge currently facing the ligand binding community is a reliance on manual processes and paper-based systems, ineffective integration, and a lack of standardization in many areas. In order to address these gaps, we identified speakers who had developed solutions to parts of the overall problem. The event spanned 2 days with participation from three distinct groups: biopharmaceutical companies, contract research organizations, and research equipment providers. The goal was to share best practices, identify gaps, and define next steps. The outcome of the meeting was the development of four sub-teams that included: reagents, instrument platforms, automation, and electronic solutions. Each sub-team was given the task of identifying the most achievable and high-impact facets to change or improve.

Analytical Quality by Design, Life Cycle Management, and Method Control

“…In addition to the concerns raised above, there are still technical challenges that need to be solved, including the development of databases that allow tracking and use of data throughout the product life cycle without extensive resource investment. Initiatives in that direction are ongoing across the industry as evidenced by the 21st Century Lab initiative that is coming of age [45,46]. The data collected during early product development must be accessible for interpretation by scientists working on the later stages of product development and the commercial phase such that the accumulated experience can be used to continue updating the ATP and MODR.…”

Surface Preparation Strategies for Improved Parallelization and Reproducible MALDI-TOF MS Ligand Binding Assays

“…Additionally, immunoassay LBAs are a robust platform for validation of candidate biomarkers designed to diagnose presymptomatic patients and stratify potential respondents (or toxicities) to specific treatments. Despite broad appeal, LBAs often have limited specificity and are susceptible to diverse interferences. , High-throughput screening approaches with improved specificity that better rationalize biological variation (e.g., post-translational modifications or splice events) or cross-reacted species (e.g., small molecule ligands) simultaneously and in the context of complex mixtures (e.g., biofluids, cell lysates, or tissue homogenates/extracts) will have a profound impact on LBA reliability and cost-effectiveness.…”