Technology Platforms

Ligand Binding Assay

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Ligand binding assay (LBA) plays a pivotal role in pharmacokinetic (PK) and immunogenicity testing, serving as indispensable tools for evaluating drug concentrations, as well as the presence of anti-drug antibodies (ADAs) in biological samples.

PK Analysis

In the context of PK analysis, ligand binding assays are utilized to measure the concentration of a drug or its metabolites in biological matrices, such as serum, plasma, or tissue, over time. These assays provide critical insights into drug absorption, distribution, metabolism, and excretion, thereby informing dosing regimens, optimizing therapeutic outcomes, and ensuring drug safety.

Immunogenicity

Similarly, in immunogenicity testing, ligand binding assays are employed to detect and quantify the formation of ADAs, which may impact drug efficacy, safety, and tolerability. By assessing the immunogenic response to therapeutic proteins, monoclonal antibodies, or other biologic agents, these assays enable the identification of potential adverse reactions, including immune-mediated adverse events and loss of treatment efficacy. Moreover, ligand binding assays facilitate the characterization of ADA specificity, affinity, and neutralizing capacity, aiding in the development of risk mitigation strategies and personalized treatment approaches.

Cut points determination
Sensitivity
Hook effect
Precision
Selectivity and matrix interference
Drug tolerance and target interference
Robustness
Short-term stability (freeze-thaw stability and benchtop stability)
Long-term stability
Domain specificity

Platforms of LBAs for PK and immunogenicity

ELISA (Colorimetric, Fluorescence, Chemiluminescence) and Hybridization ELISA (HELISA)
MSD (Electrochemiluminescence)
Quanterix Simoa
Gyros

Molecule Types

Monoclonal antibodies
Antibody conjugates
Multi-specific antibodies, antibody fragments
Therapeutic proteins
Single chain and fusion proteins
Peptides
Pegylated peptides and proteins
Oligonucleotides

Supported Services

Method development and transfer
Method qualification and validation
Cross-validation
Biological sample analysis
Critical reagent labeling, bridging, and extension
Statistical analysis (ADA/NAb cut point analysis, etc.)

Key experiments in method validation

PK
Accuracy and precision
Sensitivity and curve range
Specificity (cross-reactivity)
Selectivity and matrix interference
Dilution linearity and hook effect
Robustness
Carryover
Short-term stability (freeze-thaw stability and benchtop stability)
Long-term stability

Our Small Molecule Bioanalysis Services Include: 

Method development, transfer, partial validation, method qualification and validation, cross validation 
Sample Analysis 
Nonclinical toxicokinetic /pharmacokinetic screening 
Clinical PK/bioavailability studies 
Bioequivalence studies, including highly variable drugs and narrow therapeutical window drugs 
Therapeutic drug monitoring studies 
Drug-drug interaction studies 
Protein binding studies 
Tissue analysis 
Pediatrics bioanalysis involving micro-sampling techniques 
Liposomal drugs 
Inhalant drugs/transdermal patch with ultra-low sensitivity requirement 
Elemental Analysis (Metals) 
Amino acids analysis 
Pegylated drugs 
LNPs 
Chiral compounds requiring chiral separation 
Dose escalation First-In-Human studies  
Global late phase III studies 
Endogenous analytes or biomarker assays 
Multi-domain therapeutical proteins, including mAb, bispecific antibodies, ADCs (antibody-drug conjugates), PDCs (peptide-drug conjugates) 
Oligonucleotides

Our scientific expertise extends to projects that combine small and large-molecule bioanalytical activities such as protein, antibody, antibody-drug conjugates, biomarker analysis , gene and cell therapy drugs as well using mass spectrometry platform. A dedicated biologics LCMS team works together with our sponsors to tackle any bioanalytical challenges beyond the traditional small molecules bioanalysis.  