At RoukenBio, we specialise in the functional characterisation of large molecules and advanced therapies, helping customers to understand and define the biological activity of their products. With a unique combination of scientific expertise that spans academic-level translational research through to the application of rigorous bioanalytical methodologies, we provide flexible, phase-appropriate, and tailored solutions to deliver relevant, high-quality data that supports your drug development journey. 

Our bioanalytical and bioactivity services provide pre-developed assays to characterise all aspects of binding and biological activity of large molecules. Using state-of-the-art equipment coupled with expert knowledge of assay design, we offer a comprehensive suite of approaches to characterise binding activity to either recombinant or cell-based targets and a plethora of biological activities driven by the potential multiple mechanisms of actions that exist for today's therapeutics. In the case of antibody-based therapies, we possess world leading capabilities to assess Fcγ and C1q binding, effector function assays to investigate ADCC, ADCP and CDC using engineered target cells coupled with genotyped and functionality screened recallable primary cell donors. As your products progress to the clinic, we support potency assay development, based on bioassay design and regulatory requirements (ICH Q14 and USP1032), creating an Analytical Target Profile (ATP) to define method parameters and control strategies, ensuring long-term consistency and adherence to performance criteria.

We offer a large and diverse range of assay formats and endpoints, delivered using advanced instrumentation:

• Flow Cytometers: for high-content analysis of cell-based assays.
• xCelligence System: to monitor real-time cell behaviour.
• Plate Readers: for quantitative analysis of various assay formats.
• Biacore 8K Systems: for detailed SPR binding studies.
• Luminex: for multiplexed analysis of binding activities.
• Helixcyto: for high-resolution protein interaction analysis.