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Advancing medical device development with ex vivo human skinMedical devices are evolving rapidly, becoming more sophisticated and diverse in their applications. From injectable drug delivery systems to wound dressings, wearable sensors, and microneedles, these innovations must undergo rigorous testing to ensure safety, functionality, and biocompatibility. However, as medical devices become more complex, so do the challenges associated with their preclinicalRead more

Beyond animal models: The role of human skin in ADME testingADME (Absorption, Distribution, Metabolism, and Excretion) testing plays a vital role in modern drug development by improving candidate selection, reducing failures, enhancing safety assessments, ensuring regulatory compliance, and ultimately saving time and resources in bringing new drugs to market. Traditionally, ADME testing has relied on animal models and in vitroRead more

The future of vaccine researchThe rapid advancements in vaccine research over the past decade have transformed the way we prevent and respond to infectious diseases. The COVID-19 pandemic accelerated the development of novel platforms like mRNA vaccines, showcasing the potential for rapid innovation. However, despite these breakthroughs, significant challenges remain in vaccine research, including preclinical model limitations, immune variability, theRead more

From human skin to human data: Advancing immunogenicity testing with human modelsIn a public workshop organized by the FDA-CRCG group, Dr. Nicolas Gaudenzio, CSO of Genoskin, introduced an innovative platform for assessing immune reactions in response to injected substances using human skin explants. His talk, titled "A new in vitro framework for assessing immunogenicity using comprehensive profiling of injectable humanRead more

Top things found in human skin (vs in reconstructed human skin models) Covering nearly two square meters, skin is our body’s largest organ and a common pathway for administering drugs—whether through topical applications, subcutaneous injections, intradermal routes, or medical devices. With its complex network of immune cells, the skin plays an essential role in testing the efficacy and safety ofRead more

Research HighlightExplore our latest publication in Allergy: the story behind the idea and key findings.The landscape of vaccine research is undergoing an important transformation, thanks to the breakthroughs in mRNA vaccine technology. This innovation has catalyzed the development of vaccines that are not only highly effective but also rapidly deployable at a large scale. With the increasing number of researchRead more