Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New Biological Entities (NBE), LBAs are primary tools to detect circulating drug products for Toxicokinetics (TK) and Pharmacokinetics (PK) studies, Receptor Occupancy Assays (ROA), Pharmacodynamic (PD), soluble or cell-surface biomarkers and ADA in biological fluids and tissues, making them highly suited for determining the fate of administered substances and their impact on a living organism.
Over the years, the LBA landscape has substantially changed with the boom in the development of immunotherapies. This came with the development of more and more sophisticated tools, such as multiplexing technologies in the early 2000s for measuring soluble biomarkers, and more recently, high-content flow cytometry for cellular biomarkers, and ultrasensitive platforms in the 2010s, the utility of which was proven specifically in the field of neuropathologies1. For instance, highly sensitive Simoa technology was the first to allow for the detection, in blood, of neurological proteins, present at very low concentrations and reflecting, for some of them, ongoing pathological processes in the brain2. This has been game-changing in the field of neuroinflammation & neurodegeneration, allowing for easy monitoring of disease progression or treatment interventions.
Our comprehensive technological park helps adapt to fit a large spectrum of scientific needs
Different LBA techniques can be used depending on the assay format, the biological matrix, the nature of the biomarker, and the required sensitivity. We offer a plethora of instrumentation; for instance, our Lyon, France location offers one of the largest immuno-assay technological parks in Europe, allowing to provide the pertinent solution that best suits each project’s specifications, constraints, and Context of Use (CoU), including multiple parameters for complex assays, high/ultra sensitivity, low sample volumes, short turnaround time and high throughput, as well as study duration.
Our immunoassay platforms, suited for soluble biomarkers as well as cell surface biomarkers, include multimode readers for classical ELISA, Luminex™ for multiplexing, Ella™ Automated Immunoassay System or Meso Scale Discovery® (MSD) ECL (ElectroChemiLuminescence) technologies and ultra-sensitive platforms, such as the HD-X ™ analyzer, ImmunoSpot® ELISpot reader and high content flow cytometry, with the NovoCyte Quanteon™, the BD LSRFortessa™ instruments, which are aligned across US & EU sites, and, in our Spring House, US location the Cytek® Aurora spectral flow cytometers. This rich variety of platforms enables us to offer the most appropriate solutions to our clients.
LBAs critically depend on the availability of high-quality reagents
While LBAs are invaluable bioanalytical tools based on their high sensitivity, specificity, throughput, and relatively low cost, they critically depend on the availability of high-quality reagents.
To ensure the reliability of generated data, it is crucial to characterize and optimize the lifecycle management of associated LBA critical reagents, to have a long-term vision, and to anticipate shortages and consistency between different lots.
In addition to our large technological park, this is where our experience in several LBA formats proves effective. We can guide your project plans and anticipate your needs, by helping you elaborate a robust strategy for critical reagent management and bridging throughout the course of your study and the evolving needs of your drug development journey.
Moreover, as a global CRO, we offer alternatives for protein quantification and pharmacokinetics, such as hybrid LC-MS/MS (Liquid Chromatography Mass Spectrometry) in our Olathe, US labs. Hybrid LC-MS/MSpresents the advantages of being highly specific, offering a wide linear dynamic range, and quantifying multiple proteins simultaneously. This alternative is specifically adapted to the early stages of (pre)clinical development, at the time of lead selection, when specific reagents for each drug candidate are not readily available. Indeed, we have developed a sensitive generic approach for quantitating human and humanized mAbs in non-clinical species.
With our deep experience in LBA, our large technological park, our highly trained & fully engaged personnel, and the large panel of approaches, we work hand-in-hand with our clients to develop LBA methods – from the early discovery stage to their clinical studies. We ACT as an extension of their own lab moving from CRO (Contract Research Organization) to PRO (Partner Research Organization). Through this very close partnership, highly productive discussions, and invaluable knowledge sharing with our worldwide clients, we are ready to provide you with tailor-made solutions.
- Fischer SK, Joyce A, Spengler M, Yang TY, Zhuang Y, Fjording MS, Mikulskis A. Emerging technologies to increase ligand binding assay sensitivity. AAPS J. 2015 Jan;17(1):93-101. doi: 10.1208/s12248-014-9682-8. Epub 2014 Oct 18. PMID: 25331105; PMCID: PMC4287293.
- Kuhle J, Barro C, Andreasson U, Derfuss T, Lindberg R, Sandelius Å, Liman V, Norgren N, Blennow K, Zetterberg H. Comparison of three analytical platforms for quantification of the neurofilament light chain in blood samples: ELISA, electrochemiluminescence immunoassay and Simoa. Clin Chem Lab Med. 2016 Oct 1;54(10):1655-61. doi: 10.1515/cclm-2015-1195. PMID: 27071153.
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