Genoskin Doubles US Foothold to Launch Local Primary HumanMast Cell Production for North American Customers

Toulouse, France, and Salem, MA, USA, June 29, 2026 – Genoskin, the first Contract Research Organization (CRO) to develop ex vivo human skin platforms capable of testing injectable drugs and implanted medical devices, today announces the expansion of its US operations in Salem, Massachusetts, to support the launch of local primary human mast cell production (central regulators of human immunity) for North American customers. This initiative follows a 50% increase in mast cell manufacturing capacity at the company's French facility and reflects the growing global demand from pharmaceutical and biotechnology seeking predictive human immune cell models for drug discovery and safety assessment.

As central regulators of human immunity, mast cells are increasingly recognized as key drivers of disease biology. These tissue-resident immune cells play a key role in local inflammatory responses following injection, making them highly relevant to Injection Site Reaction (ISR) biology and drug testing. Beyond their well-established role in allergy, they contribute to inflammation, hypersensitivity, fibrosis, wound healing and tissue remodeling - processes that are critical in vaccine, biologic, drug-induced local tolerance and safety assessment.

Researchers are increasingly using mast cell-based assays to study immune activation, cytokine release, hypersensitivity risk and inflammatory responses during preclinical development. With IgE-dependent allergies and mast cell-mediated diseases, such as chronic spontaneous urticaria (CSU), atopic dermatitis and asthma, affecting up to 20% of the global population, the need for translatable human models has never been more critical. In the US in particular there is high demand for allergy and immunotoxicology research models, due to the high allergy prevalence in the country^[1].

To satisfy this North American market, Genoskin is relocating from its current 4,000-square-foot (372m²) facility with limited Biosafety Level 2 (BSL-2) laboratory capabilities into a new purpose-built 8,000-square-foot (697m²) laboratory and office facility. The new site will be operational in Q4 2026. It is designed to support commercial-scale production of primary human immune cells and will include dedicated BSL-2 cell culture laboratories, quality control and analytical testing areas, shipping and receiving infrastructure, storage capacity, conference rooms and office space for scientific and operational teams.

“This expansion of our Salem facility represents an important milestone in Genoskin’s growth strategy,” said Pascal Descargues, Ph.D., Chief Executive Officer of Genoskin. “Moving into a new 8,000-square-foot facility with significantly increased BSL-2 laboratory capabilities will provide the infrastructure needed to support local manufacturing of human primary immune cells, future workforce growth and the development of next-generation translational testing platforms for the North American market.”

By producing cells closer to its customer base, Genoskin expects to reduce international shipping and customs-related delays, improve product availability and supply continuity, shorten delivery timelines for sensitive cell-based products, and strengthen support for pharmaceutical and biotechnology customers throughout North America. The move will enable Genoskin to progressively establish local production of primary human mast cells, complementing its existing manufacturing capabilities in France and creating a stronger transatlantic production network. The Salem laboratory buildout will also allow the company to strengthen business continuity between Genoskin's European and North American operations.

“Our customers increasingly need rapid access to highly predictive human immune models. Expanding manufacturing capabilities in the United States will improve service levels, strengthen supply continuity and position Genoskin to support the growing adoption of human-relevant testing methods across the pharmaceutical and biotechnology industries,” Descargues added.

Genoskin’s mast cell offerings provide researchers with access to highly relevant human-derived cells and the specialized expertise designed to support physiologically meaningful immune studies. These capabilities enable researchers to generate data that may better reflect human biology compared to conventional immortalized cell lines or non-human models. The mast cells are produced from blood-derived CD34+ progenitors using a standardized workflow and validated by phenotypic and functional QC to confirm mature mast cell identity and ensure functionality via multiple receptors. They maintain high viability after shipment and recovery culture, supporting their practical use as ready-to-integrate research products across international sites.

“As demand for more predictive toxicity testing models continues to grow and because mast cells are among the first immune cells to respond to external stimuli, they are one of the most valuable tools for evaluating immune activation and inflammatory safety risks during drug development,” said Nicolas Gaudenzio, Chief Scientific Officer at Genoskin. “This offering complements our skin-based testing platforms and gives our North American clients faster and more reliable access to high-quality human primary mast cells to tackle mast cell-dependent disorders.”

Mast cells are particularly valuable for research projects focused on toxicity, allergy, inflammatory mechanisms and immune-related adverse events (irAEs). Human mast cells are used for direct proof of target engagement against IgE and to investigate the pathways associated with allergen-specific IgE, degranulation, cytokine production, FceR1 receptor signaling and tissue-specific inflammatory responses. In addition, mast cells can be utilized for in-house Mast Cell Activation Tests (MAT) using patient serum, offering improved diagnostics and efficacy tracking for next-generation food allergy therapies and supporting the development of safer therapeutics by helping identify unwanted immune activation earlier in the development process.

The Salem expansion is part of Genoskin’s broader growth strategy following its €8M ($8.7M) financing round in 2025 led by OCCTE (FPCI Occidev Impacts), alongside Captech Santé, GSO Innovation and CA Toulouse 31 Initiatives, with non-dilutive financing from Bpifrance and leading banking partners. This financing supports Genoskin’s next phase of growth, including doubling its workforce over the next three years, expanding its commercial presence in key global markets - particularly in Europe and Asia - and scaling operations through facility expansion in the US and France.

Genoskin also plans to invest in advanced cell culture, analytical and laboratory equipment to support large-scale manufacturing of primary human mast cells and future immune cell-based products.

The global demand for mast cells is increasing rapidly due to the regulatory shift towards non-animal testing methods, known as New Approach Methodologies, and the strong growth in human primary cell culture and cell-based assay markets.

About Genoskin

Genoskin is a Contract Research Organization (CRO) and supplier of human skin models and primary mast cells, transforming drug development through its unique expertise in skin biology and immunology. By leveraging donated human skin and proprietary preservation technologies, Genoskin provides immunocompetent ex vivo platforms that enable more translational, human-relevant testing than traditional animal or engineered models and align with the evolving regulatory expectations outlined in the FDA Modernization Act 2.0.

Founded in 2011, Genoskin offers a suite of advanced solutions to evaluate immune responses, injection site reactions and skin toxicity across therapeutics, biologics, vaccines, medical devices and chemicals. Through a combination of next-generation sequencing, advanced imaging and expert scientific guidance, Genoskin supports pharmaceutical, biotechnology and cosmetics companies in generating robust, translational human data to accelerate development with greater confidence.

Headquartered in North America and Europe, Genoskin operates state-of-the-art R&D and production facilities in Salem, Massachusetts (USA) and Toulouse, France, with about 60 employees across France and the United States.

www.genoskin.com

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