ImmunoSafe: ISR platform®
Advancing towards the prediction of clinical results
ImmunoSafe: ISR platform®
Advancing towards the prediction of clinical results
Non-clinical safety assessment with ImmunoSafe: ISR Platform®
Utilizing the foundation of the ISR Platform®, the newly introduced ImmunoSafe: ISR Platform offers a specialized approach to non-clinical safety. It integrates ex vivo cytokine analysis, cutting-edge computational analysis, and in-depth literature mining to deduce statistically significant active biological pathways that are activated at the injection site.
Bioinformatics-based analysis of human immune data to de-risk development of human therapeutics
Genoskin’s ISR platform® is an innovative service engineered to reduce the risks associated with the administration of therapeutic agents and formulations through subcutaneous and intradermal routes.
This proprietary state-of-the-art platform provides biotechnology and pharmaceutical companies with the capability to examine how their therapeutic compounds interact with human immune cells in an ex vivo environment. Leveraging advanced computational safety analysis, we ensure a precise evaluation of these interactions. To achieve a comprehensive and diversified understanding of the immune response to various treatments, we utilize a cohort of seven donors.
The data collected from these immune profiles is analysed using AUDACY, our bioinformatics-based analytics solution. The goal of this analysis is to derive significant insights regarding potential clinical outcomes. AUDACY pinpoints active biologically pathways triggered at the injection site that show statistical significance when we administer a compound to our ex vivo skin models.
Bioinformatics-based analysis of multiplex cytokine assays: AUDACY
After subcutaneous or intradermal treatment of models at Day 1, culture medium are sampled to perform multiplex cytokine analysis.
The ImmunoSafe: ISR Platform® uses models from 7 donors with 3 replicates to ensure statistically significant results of cytokine expression. This allows for more accurate characterization of the activated biological pathways implicated in the local immune response.
The exponential increase in biological data complexity has reached a point where even highly skilled experts find data analysis incredibly challenging. With this in mind, Genoskin created AUDACY (Automated Data Analysis of Cytokines), a proprietary bioinformatics-based analytical solution.
AUDACY is designed to:
- Manage large datasets and provide results quickly,
- Minimize the introduction of human error into the analysis,
- Enable novel forms of analysis.
Biological pathways associated with cytokine release in response to Cetrorelix treatment
AUDACY uses data from publicly-available, peer-reviewed online databases to gather data from various species. As AUDACY incorporates unique ex vivo human data, we can selectively extract human-related information, such as human gene and protein names.
Based on the list of cytokines and chemokines derived from the statistical analysis, AUDACY uses the Protein Interaction Network (PIN) databases to understand their interconnections. The second step entails examining biological pathway databases (such as Reactome) to gain insights into the specific mechanisms that have been activated. Ultimately, the data enable the inference of clinically-related manifestations.
Frequently asked questions
Who is the ImmunoSafe: ISR Platform® for?
Injection site reactions: A major concern among patients using injectable therapeutics or biotherapies
Injection site reactions can originate from various sources and manifest in different ways:
Biologics
Biologics such as monoclonal antibody therapies, vaccines, and cell and gene therapies are therapeutic substances derived from or contain components of living organisms. As a result, they have the potential to trigger an immune response upon interacting with the human body.
Small molecules
Small molecule therapeutics are chemically synthesized, low molecular weight compounds, which can also cause local inflammation when injected into the skin. Small molecule therapeutics are specifically designed to interact with target molecules in the body, such as proteins or enzymes, to modulate or influence their activity.
Literature present numerous instances of patient complaints reporting injection site reaction, leading to a lack of compliance and, ultimately, a less effective treatment.
How many donors are required to generate statistically significant data?
ISR platform® services rely on the use of HypoSkin®, one of Genoskin human skin technology that features the 3 layers of skin – epidermis, dermis, and hypodermis – making it the only injectable human skin model that is commercially available.
Powered by our unique technology using ex vivo human skin, we stand at the forefront of therapeutic testing innovation. Recognizing the intricate variability of human responses, especially in the context of local safety assessment, we have tailored our offer to address precision and depth. We advocate for studies with 7 unique donors and 3 replicates, ensuring robust, comprehensive data on injection site reactions. This setting not only addresses the spectrum of potential safety concerns but also fortifies the reliability of the final analysis — the active biological pathways. Such detailed insight is crucial for accurate and actionable results.
