Immunotoxicology

Cytokine release assays are essential for evaluating the potential of drug candidates to trigger cytokine storms, a severe and potentially life-threatening immune response. At RoukenBio, we provide advanced assays to assess cytokine production, delivering crucial insights for predicting and preventing adverse immune reactions. Our comprehensive approach ensures your therapeutic candidates are rigorously evaluated, reducing immune-related risks in clinical settings.

What sets our cytokine release assays apart:

• Well-Characterised Donors: we utilise highly characterised donors, ensuring precision and reliability in predicting immune responses.
• High-Content Cytokine Analysis: our assays are powered by high-content cytokine analysis methodologies, providing detailed, multi-parameter data for a deeper understanding of inflammatory responses.
• Tailored Assay Designs: we customise our approach to suit the specific requirements of your therapeutic, offering flexible options for soluble or plate-bound formats.
• Multiple Assay Formats: we have extensive experience with different formats, including:
  • PBMCs
  • High-density PBMCs
  • Whole blood

By integrating high-content analysis and custom assay designs, RoukenBio delivers precise, actionable data, helping you confidently address immune-related risks and streamline your path to clinical success.
 

On-target, off-tumour side effects are a significant concern in the development of antibody-targeted therapies for solid tumours, including immune cell engagers, CAR-T therapies, antibody-drug conjugates (ADCs), and conventional monoclonal antibodies (mAbs). Regulatory bodies, including the FDA, have stressed the importance of pre-clinical evaluation of these risks. However, effective in vitro models for assessing both efficacy and safety in this context have been limited - until now.
RoukenBio’s IndEx-2 system fills this gap by providing a cutting-edge solution to predict and evaluate on-target, off-tumour toxicities. 

Key features of the IndEx-2 system:

• Broad therapeutic applicability: Ideal for screening and characterising immune cell engagers, immune cell therapies, ADCs, and conventional mAbs.
• Precision antigen control: Employs a finely titratable inducible antigen expression system, allowing independent control of one or two receptor expression levels across a large dynamic range, all in cell lines with the same genetic background.
• Multi-Mechanism Impact Analysis: Enables assessment of antigen density’s effect on multiple mechanisms of action (MOA) using high-content methodologies, ensuring comprehensive evaluation of therapeutic performance.
• Correlated Tissue Data: We correlate data from the IndEx-2 system with primary tissue expression data, offering deeper insights into clinical relevance.
• Extensive Cell Line Portfolio: Access a wide range of off-the-shelf cell lines, or partner with us to develop custom cell lines tailored to your specific therapeutic requirements.

For further details on the IndEx-2 system, we invite you to explore our publications and scientific resources to learn more about its capabilities and applications.
By leveraging the IndEx-2 system, RoukenBio delivers the precision and reliability needed to assess on-target, off-tumour toxicities, ensuring both safety and efficacy for a broad range of therapeutic candidates.

At RoukenBio, we offer a comprehensive suite of immunogenicity assessment services to evaluate the immunogenic potential of your therapeutic candidates. Our assays are designed to provide critical insights into how your biotherapeutics interact with the immune system, helping to mitigate the risk of adverse immune responses. Our services include:

DC Maturation Assays:

• Utilise monocyte-derived dendritic cells (moDCs) to assess the potential of your therapeutic to induce ADA (anti-drug antibodies).
• Measure cell surface marker expression (e.g., CD83, CD80, CD86) via flow cytometry.
• Analyse cytokine secretion (e.g., IL-1β, IL-6, TNFα) and signalling pathway activation (e.g., AkT, Syk).
• Tailored to assess formulation factors or protein aggregation that may contribute to immunogenicity. 

T Cell Activation Assays:

• Evaluate immunogenic risk by measuring the activation of CD4+ T cells in response to therapeutic proteins.
• Multiple assay formats available, including PBMC-based assays, DC-T cell co-culture systems, and CD4+ T cell-specific setups.
• Assess key readouts such as early T cell activation markers (e.g., CD154, CD137), cytokine secretion (e.g., IL-2, IFNγ), and T cell proliferation (e.g., Ki-67 expression). 

ADA Assay Development:

• Method development and validation for assessing anti-drug antibodies (ADA), aligned with EMA and FDA guidelines.
• Tiered strategies for binding and neutralising ADA, including determination of antibody class and titre. 

Key Benefits of Our Services:

• HLA-characterised donor cohort: Our donor pool has an HLA distribution corresponding to the world population, and can be tailored to specific subpopulations of interest.
• Multiple readouts: We offer a variety of readouts to assess different modes of immunogenic potential, ensuring comprehensive evaluation.