The development pipeline for human IgG-based therapeutics is experiencing unprecedented growth, with more than 1,000 therapeutic antibodies currently undergoing human clinical evaluation and numerous additional IgG scaffolds progressing through discovery and preclinical stages. This rapid expansion creates a critical need for a robust, streamlined analytical framework capable of providing rapid and consistent quantitative measurements.
Challenges with Traditional Ligand-Binding Assay Development
Traditional de novo development of ligand-binding assays (LBAs) for each new molecule can be time-consuming, resource-intensive, and susceptible to matrix- and subclass-related variability, ultimately creating a significant bottleneck in program advancement.
Advantages of a Universal Fc-Directed Assay Platform
To address this challenge, we have developed a pre-qualified, Fc-directed generic Ligand-Binding Assay (LBA) that serves as a universal platform for human IgG therapeutics. This assay leverages the conserved Fc epitopes shared across all human IgG molecules to provide a consistent bioanalytical solution.
The primary aim of this work, and the focus of the complete findings presented here, is to demonstrate that this universal LBA platform:
- Minimizes de novo assay development.
- Reduces matrix- and subclass-related variability.
- Mitigates method transfer risk.
By establishing a single, robust method for quantitative measurement across plasma and tissue matrices, this platform critically supports early Pharmacokinetic (PK) profiling, dose-range finding, and exploratory toxicology assessments, thereby accelerating program advancement with consistent and reproducible bioanalytical performance.
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