Non-Clinical Toxicity Services

Assess local toxicity upon injection in ex vivo live human skin

Non-Clinical Toxicity Services

Assess local toxicity upon injection in ex vivo live human skin

Predicting unwanted inflammatory responses with advanced ex vivo services

Unanticipated local reactions can frequently emerge during clinical trials, leading to discomfort for patients and decreased adherence to treatment. At Genoskin, we have developed specialized ex vivo platforms tailored for non-clinical toxicity services. These platforms are ideal for evaluating potential inflammatory reactions to injections before therapeutics reach clinical trial stages or the market. You can assess inflammatory responses to subcutaneous, transdermal, and intradermal vaccines, therapeutics, and medical devices. Dive into the key features and advantages of this unique platform.

Innovative

Pioneering the future of non-clinical drug safety with cutting-edge platforms.

Human

Leveraging animal-free technology for unparalleled accuracy ahead of clinical trials.

Toxicity

Diving deep into unwanted reactions, ensuring every therapeutic is safe.

Characterization

Comprehensive insights into drug-induced immune reactions for enhanced prediction.

Obtain immune data from a unique injectable platform

ex vivo injectable and immunocompetent human skin model for non-clinical studies

Genoskin’s non-clinical toxicity services offer an innovative first-in-human approach to help you detect and understand potential injection site reactions. This ensures you select the best drug candidate and secure the continuity of 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, adipose tissue and all native human skin appendages and immune cells. These models are particularly suited to test injection site reactions ex vivo. Moreover, it allows the observation of the response from live human skin to your vaccine or therapeutic candidate in live human skin for an entire week.

ImmunoSafe: ISR PlatformLocal Tolerance: ISR Platform

Cellular toxicity studies on human primary mast cells

human primary connective tissue-type mast cells and some of its receptors

Genoskin’s research emphasizes the importance of human primary mast cells in drug toxicity assessment. Traditional research tools often fall short, especially when studying mast cells, as human primary mast cells are challenging to obtain. Genoskin offers a unique solution, providing access to connective-tissue type human primary mast cells to understand the underlying mechanisms of action with certain injection site reactions. These mast cells play a crucial role in the immune system’s response to various stimuli. With Genoskin’s platforms, researchers can obtain reliable human data prior to entering clinical trials, ensuring a comprehensive understanding of potential toxicity reactions and enhancing the safety of drug development.

The human primary cells developed by Genoskin are fully differentiated and express the MRGPRX2, FcεR1ɑ and KIT receptors.

Mast Cell Activation Platform

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Frequently asked questions

Is it possible to perform cytotoxicity studies with these platforms?

Yes, whether you are developing a biologic or a small molecule and you want to look at cell death and necrosis, we can adapt the readouts to meet your needs.

Can we test different formulations on the same donor?

Yes, we can produce enough skin models from one donor to allow testing multiple conditions, such as different formulations or different candidates in parallel.

Can I use multiple donors in one study?

Since our human data generation platforms are generated form 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 relevant and representative study data. Our human data platformsprovide the advantage of the potential to mimic small clinical trials. In order to generate statistically relevant results, Genoskin recommends using a minimum of 3 donors with 3 replicates.