RoukenBio provides specialist preclinical immunology services and preclinical research services for therapeutic developers advancing biologics, antibody-based molecules, cell therapies and immune-modulating drug candidates toward the clinic.
We integrate immunological insight, bioanalytical expertise and advanced preclinical assay development to generate robust in vitro pharmacology data packages. Our work supports lead optimisation, mechanism of action characterisation, candidate selection and regulatory readiness with essential binding, efficacy, potency and safety-relevant data.
Our pre-clinical services centre on the extensive characterisation of lead candidates, where we merge our bioanalytical, bioactivity and immunology expertise to link mechanism of action (MOA) information from biophysical data to cell-based functional assays of increasing physiological relevance. We select optimal in vitro models to generate a complete mechanistic profile, and can pair this with immuno-toxicology data, for effective safety and efficacy evaluation — taking you a step closer to the clinic.
Whether you need established preclinical assays or a custom-built model for a novel therapeutic mechanism, our scientists work collaboratively with your team to design assays that answer the right biological questions.
Biophysical Characterisation
In vitro pharmacology and extended MOA characterisation
Effector Function Characterisation
In vitro immuno-toxicology
Understanding how your therapeutic binds to its target is a critical foundation for preclinical drug development.
Our industry-leading SPR capabilities and advanced kinetic cell-binding assays enable precise analysis of binding interactions between recombinant proteins and cell-bound receptors. We perform comprehensive therapeutic-target interaction studies under physiologically relevant conditions, including dual-binding assays to assess binding dependency.
Our kinetic cell-binding assays extend to membrane-bound receptors on live cells, providing critical insights into the dynamics of receptor-ligand engagement within their native cellular context.
This dual approach ensures accurate characterisation of binding affinity and kinetics of interactions, whether in a purified system or within the complex environment of the cell membrane, and advances the understanding of your therapeutic’s molecular mechanism of action.
Understanding how your therapeutic binds to its target is a critical foundation for preclinical drug development.
Our industry-leading SPR capabilities and advanced kinetic cell-binding assays enable precise analysis of binding interactions between recombinant proteins and cell-bound receptors. We perform comprehensive therapeutic-target interaction studies under physiologically relevant conditions, including dual-binding assays to assess binding dependency.
Our kinetic cell-binding assays extend to membrane-bound receptors on live cells, providing critical insights into the dynamics of receptor-ligand engagement within their native cellular context.
This dual approach ensures accurate characterisation of binding affinity and kinetics of interactions, whether in a purified system or within the complex environment of the cell membrane, and advances the understanding of your therapeutic’s molecular mechanism of action.
Our primary immune cell assays are designed to facilitate extended MOA characterisation, support the development of your in vitro pharmacology data package and identify biomarkers.
We use a wide variety of human immune cells (e.g., T cells, NK cells, B cells) in our assays, designed to generate high-content data in a 96-well format. Key techniques include:
We also access primary patient material via our relationship with local biorepositories, validating mechanistic data from in vitro models providing insight into biomarkers for clinical study design.
For antibody-based drugs, our end-to-end characterisation solutions cover everything from target and Fcγ receptor binding to immune cell activation, signal transduction, and ultimately target cell death or phagocytosis.
We offer assays for Fcγ and FcRn binding, C1q binding, ADCC, ADCP, CDC, and trogocytosis. Our bioanalytical experts deliver accurate and robust solutions that allow for fine resolution of effector function, using internally available target cell lines, engineered target cell lines, reporter, and primary effector cell populations, supported by:
We tailor our immunotoxicology services to your specific needs by combining industry-standard approaches, cutting-edge technologies and advanced tools. Our customised assays align with regulatory expectations and our models address unique challenges, ensuring thorough safety evaluations to de-risk your path to the clinic. Our expert team navigates all complexities and delivers exceptional results in:
Novel therapeutics often require novel assay systems. RoukenBio’s strength lies in designing and developing custom preclinical assays that reflect the biology of your molecule, rather than forcing your programme into a standardised platform.
Our scientists work with you to understand your therapeutic hypothesis, target biology, mechanism of action and key development questions. We then design assays that can generate meaningful, reproducible and interpretable data.
Our preclinical assay development expertise can support:
This makes our preclinical research services particularly valuable for biologics, bispecific antibodies, immune checkpoint modulators, Fc-engineered antibodies, cytokine-targeting therapies, cell therapies and other immune-mediated therapeutic approaches.
Whether you need established preclinical assays, bespoke preclinical assay development, or a fully integrated in vitro pharmacology and immunotoxicology package, RoukenBio can help you generate the data needed to progress with confidence.
RoukenBio provides preclinical immunology services spanning biophysical characterisation, in vitro pharmacology, effector function testing, immunotoxicology, product characterisation, and custom cell engineering to support therapeutic development from discovery through preclinical stages.
These preclinical research services are designed to generate robust, human-relevant data packages that support lead optimisation, mechanism-of-action characterisation, candidate selection, and early safety assessment.
