Surface Plasmon Resonance (SPR) Binding Analysis
Regulatory agencies such as FDA and EMA expect every protein-based biologic to be characterized not only by its physicochemical properties, but also by bioactivity, immunochemical properties, purity and impurities. Within this framework, binding properties, affinity and kinetics are, next to safety, among the most critical quality attributes (CQAs) of a biopharmaceutical drug or therapeutic.
Correct target and receptor binding is essential to ensure pharmacological activity, activation/deactivation of pathways and proper distribution and transport in human tissues. Robust binding data are therefore fundamental for lead selection, potency assessment, comparability and biosimilarity studies.
At Biofidus, we use our Biacore 1K surface plasmon resonance (SPR) platform to deliver fast, label-free binding data for an in-depth characterization and comparison of biologics and biosimilars. Biacore SPR has long been considered the gold standard for SPR analysis, providing exceptional sensitivity, accuracy and reliability for affinity (KD) and kinetic (kon, koff) measurements, making it a preferred system for drug candidate characterization and CMC support.
Thanks to a wide range of available sensor chips, flexible assay formats and powerful data analysis software, our Biacore SPR assays are highly customizable. We design tailored experimental pipelines that match your mechanism of action, molecule class and development stage.
Our experienced scientists guide you in line with ICH and regulatory expectations and provide fit-for-purpose SPR bioanalytical packages to support early discovery, lead optimization, CMC development, comparability and biosimilarity.
In accordance with your needs, we adapt and, where required, qualify our SPR methods, tailored to your pharmaceutical product, its formulation matrix and your specific analytical questions.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
