Preclinical

We integrate immunological and bioanalytical design to provide comprehensive in vitro pharmacology data packages, supporting lead-optimisation and regulatory submissions with essential binding, efficacy and potency data. 

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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.

Biophysical Characterisation

In vitro pharmacology and extended MOA characterisation

Effector Function Characterisation

In vitro immuno-toxicology

Biophysical Characterisation

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.

In vitro pharmacology and extended MOA characterisation

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:

  • Multi-parameter flow cytometry (up to 25 colours) using the Novocyte
  • Multiplex cytokine analysis (up to 40 analytes) using Magpix Luminex or LegendPlex
  • Kinetic assessments of cell viability or cytotoxicity using the xCELLigence RTCA 
  • 3D cell assays with our partner ScreenIn3D

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.

Effector Function Characterisation

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:

  • Direct access to recallable PBMC and whole blood donors (CD16a genotyped: V/V, V/F, F/F; CD32a genotyped: R/R, R/H, H/H; 4-digit HLA status known).
  • Readily available cryopreserved PBMCs.
  • Functional pre-screening assays for optimal donor selection.
  • Isolated immune cells (stored banks or freshly prepared).
In vitro immuno-toxicology

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:

  • Cytokine Release Assays/Infusion Related Reponses
  • Unwanted immunogenicity (ADA assessments)
  • Immunogenicity Hazard Assessments
  • “On-target, Off-tumour” risk profiling

Propel drug discovery breakthroughs with RoukenBio

Difficulty doesn’t deter us; it inspires us. Give us a problem, and we’ll find your solution. Our versatile specialists embrace every obstacle as an opportunity to showcase our innovative thinking and problem-solving prowess.

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