INJECTION SITE REACTIONS

A patented human-based platform to address injection site reactions at the organ, cellular & molecular levels

Standardized

The ISR platform allows to create reproducible assays for reliable results that are supported by unbiased data analysis.

Characterization

Our unique ISR platform helps you gain a deep understanding of inflammatory events at tissue, cell and/or molecular level.

Injections

The ISR platform allows to study response to subcutaneous and intradermal injections using the HypoSkin® model.

Adverse events

Studying injection site reactions prior to clinical trials helps you predict the number one complaint from patients upon injection.

Injection Site Reaction

ISR at a glance

Injection site reaction is typically describe as fast and local inflammatory reaction that occurs upon subcutaneous injection of a therapeutic formulation

It is characterised by erythema, swelling and pain. Today injection site reaction is the most commonly reported adverse effect upon injection of a biologic. In december 2020, Baden et al. showed that 84.2% of vaccination with a mRNA-1273 vaccine against SARS-CoV-2 led to an injection site adverse effect.

It is now a major challenge to identify next-generation drug candidates faster & safer

With the ISR platform, we provide biopharmaceutical companies with proprietary tools to better assess the capability of drugs to trigger mast cells-dependent and independent inflammatory response upon subcutaneous injection.

A unique injectable ex-vivo human skin model to better understand injection site reaction

Upon injection of a therapeutic molecule or formulation in a standardized healthy and immunocompetent human skin model, we analyse mast cells degranulation, cytokine release & perform mRNA sequencing to precisely characterize the type of inflammatory reaction we are encountering

ISR genders

Multiple donors of different age, gender and ethnicity

Parallel testing ISR

Parallel testing of different compounds in the same donor

Degranulation ISR

Artificial intelligence-assisted MCs degranulation scoring

Injection Site Reaction Workflow
Positive & negative controls.
Triplicate conditions.
MCs granules stained with conjugated avidin.
DAPI counter-staining.
Fluorescent microscopy.
AI-assisted degranulation scoring and image processing.

Mast cells degranulation observed on a full-thickness epidermis & dermis human skin sample after subcutaneous injection of IL-1R antagonist (Avidin & DAPI)

Human primary mast cell assays to better understand degranulation

Immune reaction can result from mast cells triggered either directly or indirectly

Genoskin mast cells assays are performed on connective tissue-type human primary cells in culture to generate more relevant human data and support data previously obtained in our injectable skin model.

Assays performed on functional human primary mast cells in culture provide a better understanding of the pathways through which these immune cells are triggered

Mast Cell Degranulation

Connective tissue-type mast cells production and assays workflow: Peripheral blood obtained from healthy adult donors. In a 3-month process, we are able to obtain mature mast cells that show the same metabolism and expression as in the human body.

2 weeks lead time

High throughput screening

Multiple formulations tested per donor

Connective tissue-type mast cells in culture

Connective tissue-type mast cells in culture.

Human primary connective tissue-type mast cells cultured for 3 months and stained with fluorescent avidin and DAPI

Human primary connective tissue-type mast cells cultured for 3 months and stained with fluorescent avidin & DAPI.

Complementary cell-line assays to evaluate MRGPRX2 activation

Complementary cell-line assays on cells expressing MRGPRX2 based on Genoskin proprietary platform allows formulation optimization or screening of new drug-candidate

High throughput screening

Target specifically MRGPRX2

Rapid & sensitive readout

Depending on your needs, assays can be performed starting at any level of the platform. Genoskin team of experts will guide you & provide you with a custom study plan to answer your question.

For more information about our ISR platform and its application, please contact us.