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

阿尔赛诺组学有限公司从我们目前获得专利的皮肤测试(Skimune™)中开发出一种新的概念验证人类皮肤等效模型(Skimune™-3D)。这两种检测方法都使用健康的志愿者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，使用LaunchPad资金，是为了制作一个可复制、可制造的™-3D模型，并提高可伸缩性和寿命。我们将使用一组已知的阳性对照和阴性对照来评估新模型的寿命和重复性。使用健壮的协议和用于制造的发布规范，我们将测试至少十个独立的Skimune™-3D批次。将针对Skimune™-3D建立新的标准操作规程和测试方案，并对照当前的Skimune™整体皮肤测试进行验证。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。与我们现有的和NE流程扇区集群客户合作，我们将试用新的Skimune™-3D分析。我们还将利用LaunchPad可以提供的业务和市场支持设施，以接触集群和市场的新客户，例如化妆品安全测试、毒理学和分层药物。

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.