What are ligand binding assays?
Ligand binding assays (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.
Our LBA 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, and the Cytek® Aurora spectral flow cytometers.
Supporting our clients through scientific and regulatory challenges
Ligand binding reagents are a critical part of any successful assay development. The experience required to assess specificity and characterization of reagents has profound impact on whether a method will meet its objective or be cause for constant challenges in assessing the data confidently. Assessing common method challenges such as matrix interference, non-specific binding and cross-reactivity are critical to a method’s performance to truly understand the method’s ability to support current and future development needs. Methods may require eventual modifications to assure the method is suitable for producing the data required to truly understand how the drug is working.
It may be necessary to optimize the characterization of a ligand binding assay as a drug advances through the development pipeline towards approval in order to better understand the strengths and limitations of an assay and how the results should be interpreted. Meeting regulatory requirements for these methods requires an ongoing focus from KCAS Bio and anticipating impactful changes to the methods used to evaluate the development related samples from non-clinical or clinical samples GLP/GCP related studies.
KCAS Bio provides the capacity using these latest technology platforms:
• MSD SQ120
• Flow Cytometry
There is an ever growing need to use Ligand binding assays to assess the efficacy of a therapeutic product. Over the years these assays have changed from the use of radioactive assays and strictly ELISA methods to Electrochemiluminescence immunoassay (ECLIA) methods. KCAS has a vast amount of knowledge and experience with a wide variety of LBA assays. With a large LBA team of over 60 FTEs and counting, KCAS can help overcome challenging assays as well as help to meet crucial timelines.
Ligand Binding Assay Platforms:
- Meso Scale Discovery (MSD)
- Luminex Technologies
- Enzyme immunoassay (EIA)
- Fluorescence immunoassay (FIA)
- Automated ELISA systems (Hamilton and Tecan)
- Hybrid assay (bioLC-MS) Ligand binding assay with LC-MS detection
KCAS supports the bioanalysis of Large Molecules including both Nonclinical and Clinical studies. Studies supported by Ligand Binding Assays include:
- Pharmacodynamic Biomarkers
Something to keep in mind
Immunoassay bioanalytical methods are a mainstay in today’s development requirements for biologics. Ever increasing complexity of molecules in development requires advanced expertise and experience to develop robust methods to detect and quantify targeted analytes. Selecting a CRO that has the capabilities and expertise to evaluate, develop and deliver reliable solutions for immunoassay programs is a critical outsourcing decision.
KCAS Bio is an industry leader in immunoassay development, validation, and sample analyses with vast experience in essentially all methodologies in support of your development needs.
We also provide high throughput immunoassay support for drug development using assay formats developed internally or provided by the client. Our facilities employ state-of-the-art automated liquid handling systems to increase accuracy and precision and decrease turnaround time.
The journey begins now
KCAS Bio routinely supports development programs from early discovery, through nonclinical, and on to any scale or size of clinical program. Our experts are here to assist in this development journey and help keep your program on track with expected regulatory guidance requirements. As your provider, we will be with you at every step of the development process.
KCAS Bio's Ligand Binding Assay instrumentation
At KCAS Bio, LBAs have been a core activity for over 10 years. We offer a plethora of instrumentation allowing to provide the pertinent solution that best suits your 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.
We can guide your LBA-based project plan 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.
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.
At KCAS Bio, we combine technical expertise and capabilities with state-of-the-art operational infrastructure so that we can scale and adapt quickly to the needs of your project.
'Quality by design' drives every aspect of our work. Our facilities, security and IT infrastructure ensure your samples remain protected at all times, while cultivating excellence and innovation among our scientists.
Bringing technical innovation to time-critical research
KCAS Bio partners with leading technology providers so our scientists and clients have access to gold-standard, cutting-edge technologies.