Serology

Accurately measure binding kinetics in conditions closer to real life and confidently characterize the tightest binders

Traditionally, pharmacokinetic studies have relied on end point methodologies such as enzyme-linked immunosorbent assay (ELISA). Although these approaches are usually compatible with biofluids, they do not provide real-time analysis and can be extremely labor-intensive. End point assays also typically require labeled reagents, which can add additional steps to workflows and have the potential to introduce artefacts.

Drug availability for pharmacokinetics is dictated by protein binding

Pharmacokinetic (PK) studies are an essential component of the drug development life cycle. Used to characterize drug exposure, predict dosing requirements, and guide formulation design, pharmacokinetics involves comprehensive evaluation of drug absorption, distribution, metabolism, and excretion (ADME) over time.

A major challenge faced by researchers studying pharmacokinetics is that the availability of drug molecules for these experiments is dictated by the extent of drug binding to proteins in biofluids such as blood, cerebrospinal fluid (CSF), and urine. These effects may differ significantly between animal models and human subjects, or even between individuals in the same study, translating to an altered pharmacokinetic profile.

Drug binding to antibodies impacts pharmacokinetic readouts

One type of drug-protein interaction that complicates pharmacokinetic analyses is drug binding to antibodies; this can impact the robustness of pharmacokinetic data in several ways. First, the antibody profile in biofluids such as serum or plasma is highly variable between individuals, meaning that drug binding changes according to antibody abundance and binding affinity. Second, drugs may induce an immune response resulting in the production of anti-drug antibodies (ADA), which can profoundly alter the pharmacokinetics by inactivating the drug or preventing its detection in downstream analyses.

Understand serum/plasma interference

Antibody profiles differ greatly between individuals. These variations, in combination with drug binding to other proteins that are present in serum or plasma, can impact on the concentration of freely circulating drug and in consequence its pharmacological effect. Pharmacokinetic studies must therefore accurately detect, quantify and characterize changes in drug binding to antibodies and other proteins within biofluids.

Serological studies for COVID-19 research

Analysis of molecular interactions between antibodies and SARS-CoV-2 spike protein in complex matrices like patient blood serum and plasma is of great interest to researchers studying infectious diseases like COVID-19. Matrix components like serum albumin are incompatible with label-free surface-based biosensors due to potential deleterious effects on the microfluidics and high non-specific binding. The Creoptix^® WAVEsystem overcomes these limitations with innovative disposable, no-clog microfluidics and crude-sample robustness normally only possible with plate-based assays (ELISA).

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