Subcutaneous injection using needle and syringe is one of the most common method of drug delivery today. Despite more and more extensive use, there are still no accurate biological models to predict efficacy and toxicity of compound injected in the subcutaneous tissue.
New drugs formulations are generally tested in vivo on animals (mice, rats, dogs, pigs etc.), even though their skin and subcutaneous fat tissue are different from humans. As a result, none of them are recognized as universal and reliable models to predict human subcutaneous bioavailability.
Pharmaceutical industry and medical device manufacturer main pain point is a lack of biological model allowing to truly evaluate and to optimise a new compound’s formulation before clinical trials, which leads to a loss of more than €1 billion per drug development. In addition to the low predictability, animal experiments are expensive and present strong limitation regarding ethical issues.
HypoSkin® is currently the only existing ex vivo test containing human skin with hypodermis allowing reliable testing of subcutaneous injections, with long life time provided in a ready and easy to use format. Expected results until the end of the project are as follows: scale-up, automation and industrialisation, further functional and pharmacological qualification in operational environment (pharmaceutical company) using subcutaneous injection of reference drugs (Insulin and/or monoclonal antibodies for example). All actions necessary for successful market access will be realized such as FDA or EMEA validation of the HypoSkin® model for toxicology/potency testing and the marketing and commercial development: worldwide market study, web site, world-wide communication, congresses, etc.
