Bioanalytics In Drug Development And QC

The SPR/Octet platform provides a comprehensive screening and characterization tool across a diverse range of applications during drug development and is especially versatile in antibody and protein quantitation, contaminant testing and general product characterization. This platform circumvents the limitations of ELISA and HPLC platforms, enabling informed decisions to be made earlier in bioprocess development.

Quantitation assays with SPR/Octet System

Our simple sample analysis approach that allows for the use of 96- or 384-well plate formats enables streamlined workflows and rapid quantitation of as many as 96 samples in as little as 2 minutes. In a typical quantitation assay, biosensors coated with capture molecules that bind specifically to the analyte are simply dipped into analyte samples placed in a microtiter plate. The resulting binding is later analyzed using either the rate of the initial slope of binding or the equilibrium of binding; both dependent on sample concentration. To quantify samples, a standard curve is generated using the binding rates of known concentrations of the same analyte as the unknown. The unknown sample concentrations can then be extrapolated from the standard curve. 

Binding assays with SPR/Octet System

For binding analysis, a ligand molecule can be captured onto the desired biosensor surface based on the chemistry of the biosensor. The choice of the ligand molecule is dependent on the assay of interest; for example, a biotinylated lectin specific to a given glycan could be immobilized onto a Streptavidin biosensor and used to screen for the presence of the glycan on the molecule of interest. A chaperonin protein could also be immobilized in a similar manner and used to screen for the

presence of hydrophobic populations in a biological sample to evaluate its stability. Moreover, for antibody:antigen binding assays, off the shelf biosensors including Anti-Human Capture (AHC) and Anti-Mouse Capture (AMC) biosensors allow for the immobilization of antibodies without the need for purification, and are typically cheaper than comparative sensor chips from other label-free technologies.

Lead Molecule Characterization with SPR/Octet System

Once a drug candidate has been purified, functionality studies including receptor binding analysis follow. The SPR/Octet platform is optimally designed to enable the rapid screening of thousands of monoclonal antibody clones for the quick selection of the lead candidate. The technology allows for characterization of effector functions, complement binding and potency assessment amongst other applications through target binding assays. It further facilitates cross blocking studies to enable the grouping of selected clones into bins based on competition for the target antigen’s binding epitopes.

Further downstream, the SPR/Octet system is highly versatile in Fc receptor binding analysis for selected candidates; a variety of off the shelf biosensor chemistries allow for a more flexible assay design.

Formulation and Stability Assessment with SPR/Octet System

Formulation development is the critical last step in downstream bioprocessing. Production and storage media play a critical role in the activity and stability of biological therapeutic drugs.

Unlike traditional tools like dynamic light scattering (DLS) and Circular Dichroism (CD) that mainly measure stability parameters such as onset of aggregation or melting temperatures, the SPR/Octet platform can be used to evaluate both stability and functional characteristics of these biological molecules.