Improving manufacture and commercialisation of a 3D skin model for drug safety

Alcyomics Ltd从我们目前的专利皮肤测定（Skimune™）中开发了一种新的概念验证人体皮肤等效模型（Skimune™-3D）。这两种检测方法都使用健康志愿者的血液和皮肤样本来评估药物和化合物的不良免疫反应。我们的目标是，利用Launchpad的资金，制造一个可复制的可制造的Skimune™-3D模型，具有更高的可扩展性和寿命。我们将使用一组已知的阳性和阴性对照来评估新模型的寿命和可重复性。使用具有制造发布规范的强大协议，我们将测试至少十个独立的Skimune™-3D批次。将建立Skimune™-3D的新sop和测试方案，并针对目前的Skimune™全皮试验进行验证。我们的模型是第一个能够评估不良免疫反应的3D皮肤模型。我们将与现有的和NE过程部门集群客户合作，试用新的Skimune™-3D分析。我们还将利用Launchpad提供的业务和市场支持设施，以接触集群和市场中的新客户，例如化妆品安全测试、毒理学和分层医学。

Alcyomics Ltd, has developed a novel proof of concept human skin equivalent model (Skimune™-3D) from our current patented skin assay (Skimune™). Both assays use healthy volunteer blood and skin samples to assess drugs and compounds for adverse immune reactions. Our objective, using Launchpad funding is to make a reproducable manufacturable Skimune™-3D model with improved scalability and longevity. We will assess the longevity and reproducibility of the new model, using a panel of known positive and negative controls. Using robust protocols with release specifications for manufacture we will test at least ten independent Skimune™-3D batches. New SOPs and testing protocols for Skimune™-3D will be established and validated against the current Skimune™ whole skin assay. Our model is the first 3D skin model capable of assessing adverse immune responses. Working with our existing and NE Process Sector Cluster clients we will trial the new Skimune™-3D assays. We will also avail of the business and market support facilities the Launchpad can offer to access new customers in the Cluster and markets e.g. cosmetic safety testing, toxicology and stratified medicine.