A unique research tool for injection site reaction studies
Human response to your vaccine and drug candidates
First-in-human data without harming humans or animals
Local adverse events are too often discovered upon injection during clinical trials, causing unexpected pain to volunteers and resulting in lower patient compliance. Genoskin has designed a unique platform to study inflammatory side-effects to injections prior to clinical trials. Our ISR Platform® helps you assess and predict inflammatory response to subcutaneous, transdermal and intradermal vaccines, drugs and medical devices. A quick overview of the platform’s features and benefits:
Unbiased automated machine-learning based analysis of immunotoxicity and cytotoxicity.
Deep knowledge of drug-induced pseudo-allergic reactions to better prevent and mitigate them.
Local biological response to self-injected drugs from live, immunocompetent human skin.
Predict the number one complaint from patients upon injection of biologics, prior to clinical trials.
What are injection site reactions?
Injection site reactions (ISRs) are fast, localized inflammatory reactions, characterized by pain, itch, swelling, and erythema. They are one of the most commonly reported adverse effects upon injection of a biologic drug. ISRs are known as “pseudo-allergic responses” as these reactions are not mediated through the classical IgE-mediated mast cell degranulation pathway.
Why study injection site reactions?
With the rapid growth of the biologic drugs class over the past two decades, a massive increase in unwanted immunogenic response has been reported. Too often, local adverse effects are only discovered at the clinical trial stage or when a drug is already on the market. As a consequence, they may delay the drug development process and increase associated costs or negatively affect patient compliance when discovered after the drug is put on the market.
Obtain data from our unique injectable platform
Live response from immunocompetent human skin
Genoskin offers an innovative first-in-human approach to help you detect and understand potential injection site reactions in order to select the best drug candidate and secure your development process. We inject your drug or vaccine into a healthy, biostabilized and immunocompetent human HypoSkin® model to characterize potential ISRs.
The HypoSkin® platform contains real human epidermis, dermis and adipose tissue and all native human skin appendages and immune cells. The model is particularly suited to test injection site reactions ex vivo and observe mast cell degranulation in situ. Moreover, it allows to observe response from live human skin to your vaccine, needle or drug for an entire week.
Study human immunotoxicity and cytotoxicity in response to your drug
Custom experiments to help you move forward
Genoskin’s ISR platform® helps biotech and pharmaceutical companies understand and mitigate injection site reactions and determine the right formulation for their drug candidate, biosimilar or marketed drug. Depending on your needs, our expert immunologists design custom experiments to provide reliable answers and help you move forward safely.
First-in-human data on immunotoxicity
Unbiased Multiplex Cytokine Assays
In order to help you predict active biological processes at the site of injection, we study the immunotoxicity of subcutaneous or intradermal drugs, vaccines and medical devices directly in our live and immunocompetent HypoSkin® models. This unique approach provides the missing link between preclinical and clinical trials. It helps you obtain live immune response to different formulations from a cohort of healthy skin models to better understand immune response.
To collect all the relevant data, we simultaneously measure the proteins released in the HypoSkin® culture medium and matrix. Cytokines are dosed using the MesoScale technology. The data are then clustered using our proprietary AUDaCY (AUtomated Data Analysis of CYtokines) application, to profile inflammation at the proteomic level, highlight the mechanisms involved and associate real-world evidence to better predict clinical outcomes.
First-in-human data on cytotoxicity
Predict local toxicity for self-injected drugs
Genoskin’s ISR platform® helps you de-risk clinical trials via cytotoxicity studies on living human skin from a cohort of healthy donors. Genoskin’s ISR platform® helps biotech and pharmaceutical companies understand and mitigate injection site reactions and determine the right dosage for their drug candidate, biosimilar or marketed drug. When it comes to research on immunotoxicity, the platform generates first-in-human data on loss of cell viability, signs of cell death and cytokine release.
Identify loss of cell viability
To provide reliable data on loss of cell viability in human skin, our skin biology experts perform histological analyses to quantify pyknosis, epidermal detachment, papillary dermis alteration or breaks in adipocyte membranes.
Detect signs of cell death
Our experts perform a range of immunofluorescence assays, such as TUNEL assays, to detect DNA breaks. We also conduct spectrometry analyses of LDH release to measure cell death.
Explore cytokine release
To generate an injected drug’s proteomic signature and better characterise off-target events, we combine multiplex cytokine assays with Audacy, our proprietary software that allows automated clustering of cytokines for unbiased analysis.
Study reactions for multiple donors
Include donor diversity to increase data relevance
Since our human data generation platforms only contain donated skin, it is possible to conduct studies on multiple donors to represent the diversity of the human population or of your target audience. The characteristics of our skin models are donor-dependent and reflect the natural biological diversity of the general population, allowing for more accurate and relevant study results. Our human data platforms are one of the great strengths of our approach, which offers the added possibility of mimicking small clinical trials. In order to generate statistically relevant results, Genoskin recommends 3 to 5 donors and 3 replicates.
Multiple donors of different age, gender and ethnicity
Parallel testing of different compounds in the same donor
Take your research one step further
Discover what triggered the adverse event
Genoskin associates cutting-edge technology with proprietary AI-based analytical applications to help you understand the mechanism of action behind the adverse effect we observed in situ or following a clinical trial. We generate the unique biological signature left behind by your biotherapeutic agent to select the drug candidate or formulation that is least likely to trigger injection site reactions, combining our MANTIS® spatial biology platform and RNA sequencing.
Interested in seeing how others use our ISR® Platform?
Feel free to have a look at this case study to see how one of our customers mitigated injection site reactions using the ISR Platform®.