Biologics

Biologics

Real is Natural

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

Unlike traditional small molecule drug products, which typically exist as a single chemical entity, biologics such as antibodies, nanobodies, and other large molecules manufactured in living systems are highly complex. This makes characterizing them challenging, especially since many biologic drugs exist as multiple variants, the nature and abundance of which is heavily influenced by the manufacturing process.

Characterization of biologics provides essential information regarding drug stability and performance, yet for any characterization data to be truly informative, it is essential that the properties of the biologic are assessed in relevant sample matrices.

Accelerate biologics development

The Creoptix™ WAVEsystem enables researchers to study biologic drugs in a wide range of biofluids and other complex matrices. With superior sensitivity to conventional Surface Plasmon Resonance (SPR) technologies for more accurate measurement of binding affinity and binding kinetics, the Creoptix™ WAVEsystem is driving biologics development.

Antibody-based therapeutics require evaluation under native conditions

Monoclonal antibodies (mAbs) are currently the largest biologic drug class, with multiple products approved in recent years for cancer and various inflammatory diseases. This success is attributable to the high specificity and affinity of monoclonal antibody therapeutics for their targets. However, to identify a drug candidate most likely to achieve clinical efficacy, it is essential to build a thorough understanding of these properties to learn how they may be influenced by the physiological conditions to which the antibody will be exposed.

Binding affinity is arguably one of the most widely studied properties of a biologic such as a monoclonal antibody. But unless it is evaluated alongside other qualities of the drug, binding affinity cannot provide sufficient information to predict clinical efficacy. Comprehensive characterization in biologic drug development should also include real-time analysis of binding kinetics through accurate measurement of association and dissociation rates for the antibody-target interaction. Moreover, to enable the translation of these results to the clinic it is necessary for these studies to be performed under conditions that mimic the native environment as closely as possible.

Sample type can influence the characterization of diagnostic and therapeutic biomarkers

The use of paired antibodies in an enzyme-linked immunosorbent assay (ELISA) is a popular approach to monitor the efficacy of a biologic drug. Most commonly, it is employed to detect and monitor levels of a diagnostic or therapeutic biomarker. However, despite widespread uptake, the technique suffers from several key limitations.

First, the sample type can impact significantly on assay robustness; ELISA often struggles to detect low abundance analytes in biofluids since antibody reagents are not routinely tested in clinical sample materials. Second, ELISA necessitates the use of labeled reagents; these can add additional steps to workflows and have considerable potential to introduce artefacts. Finally, ELISA protocols typically involve long incubation times to generate results of mixed accuracy and precision. In combination, these factors can lead to the performance of a biologic being inaccurately reported.

The Creoptix™ WAVEsystem allows researchers to avoid the risk of antibody-based assay failure by providing robust evaluation of antibody pairs. Profiling individual antibodies in both buffer and biofluids prior to assay development delivers improved understanding of antibody performance and stability to guide reagent selection for more reliable ELISA results.

  • Identify the most effective antibody pairs

    Explore various pairing possibilities and operate within the widest range of binding kinetics on the market.

  • Go low

    Exploit our crude sample robustness to detect analytes in biofluids at low LODs (80ng/ml in serum).

Robust with multiple applications. Dependable results with high sensitivity

James Schouten, PhD

James Schouten, PhD,

Principal Scientist at Mologic

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