Skin Metrology for Optimised Automation of the Ten Bio Device Portfolio

乔恩·沃尔默博士(Medpharm研究生物学与创新高级总监)在评论本项目的Focus产品时表示：“每个人都知道紧张度对皮肤健康起着关键作用。终于有人想出了如何将其融入产品中。这是巨大的！”制药和化妆品行业需要先进的皮肤模型，以模拟活体人类皮肤的性能。鉴于对动物试验的限制越来越多，这种情况比以往任何时候都更加明显。邓迪大学的一家屡获殊荣的衍生公司Ten Bio提出了一个解决方案，他们开发了一种独特的平台，在受专利保护的紧凑型平台中使用人类皮肤，并保持皮肤处于拉伸状态。已经发现，以这种方式施加张力不仅可以增加产品生存能力的寿命，还可以保留竞争技术无法比拟的明显水平的功能，将潜力扩展到过多的其他应用，包括预测性药物反应甚至伤口愈合。虽然Ten Bio是一家年轻的公司，但他们在世界舞台上的存在已经激起了业界对其潜力的好奇。因此，Galderma退休的研究主管、Ten Bio咨询委员会现任主席Braham Shroot[关于Ten Bio的TenSkinTM产品]评论说：“该领域没有这样的产品。你已经开发了一项将扰乱市场的技术。这是非常令人振奋的。“目前，该公司的主要产品生产缓慢，劳动密集型，每小时约4台。有鉴于此，Ten Bio已经与专业的工业产品设计工程师(i4产品设计有限公司，(I4PD)爱丁堡)进行了接触，以期实现生产自动化，并自那以后发现了与安装和拉紧皮肤进入最佳状态这一步骤相关的瓶颈。这个问题与皮肤的复杂粘弹性行为有关，本质上是问：我们能以多快的速度拉伸皮肤，在生产过程中不会对皮肤造成不可逆转的损害？我们相信，通过对Ten Bio用于张力测试的现有仪器进行改进，以及增加另一个传感系统，可以直接评估或以可靠的方式推断在特定应变率下设定拉伸时产生的瞬时张力水平，就可以回答这个问题。这里采用的方法涉及使用商业仪器和内部构建的设备对皮肤样本状态进行快速原位和非侵入性光学传感，这将导致对皮肤样本张力的快速远程和非破坏性评估，而不需要接触方法，并且不仅应该作为一种可靠的方法来识别材料限制，这些材料限制了制造过程中的速度决定步骤，而且还可以作为自动化制造过程中的质量保证步骤。借调人员带来了概念形成和仪器开发方面的专业知识，以及一套最先进的成像和外围工具，用于表征产品。在预期测量的基础上，我们预计主要产品将转换为TRL6，同时扩大公司投资组合，为进入一个估计价值20亿美元的市场做好准备。让·菲利普·塞瑞恩博士(Tergus PharPharmticals的前生物学主管，现在是Ten Bio的咨询委员会成员)的最后一条评论强调了这种市场开拓的潜力：我们通常不会购买Genoskin提供的那种现成产品，因为这些产品没有什么我们自己做不到的。然而，您的产品不同。我们不能做你们所能做的事。

"Everyone knows that tension plays a key role in skin health. Finally, someone has figured out how to incorporate it into a product. This is huge!"Jon Volmer PhD (Senior Director of Research Biology and Innovation at Medpharm) commenting on the present project's focus product. The pharmaceutical and cosmetics sector have a need for advanced skin models that mimic the performance of living human skin. This situation is more pronounced than ever given increasing restrictions on animal testing. A solution has arisen from Ten Bio, an award-winning spin-out company from the University of Dundee, who have developed a unique platform that employs human skin within a patent-protected compact platform and that maintains the skin in stretched form. The application of tension in this manner has been found to not only increase the longevity of the product's viability, but also retains a demonstrable level of functionality that competing technologies cannot match, extending potential towards a plethora of additional applications including predictive drug response and even wound healing. Whilst Ten Bio is a young company, their presence on the world stage has already piqued industry's curiosity as to its potential. So much so, that Braham Shroot, the retired head of Research at Galderma, and now Chair of the Advisory Board to Ten Bio, has commented [in relation to Ten Bio's TenSkinTM product]: 'There is nothing like this in the field. You have developed a technology that is going to disrupt the market. This is very exciting."At present, production of the company's main product is slow and labour intensive at about 4 units per hour. In light of this fact, Ten Bio have engaged with expert industrial product design engineers (i4 Product Design Ltd., (i4PD) Edinburgh) with a view to automating manufacture and have since identified a bottleneck here related to the step involving the mounting and tensioning of skin into its optimal regime. The issue relates to the complex viscoelastic behaviour of the skin and essentially asks the question: how fast we can stretch skin, and by what extent, without damaging it irreversibly in the production process?We believe that that question can be answered with a modification to the existing instrumentation used for tension testing at Ten Bio, and with the addition of a further sensing system that can either assess directly, or infer in a reliable fashion, the instantaneous level of tension arising for a set stretch at a specific strain rate. The methodology to be applied here relates to fast in-situ and non-invasive optical sensing of the skin sample's state using commercial instrumentation and in-house constructed equipment that will lead to a fast remote and non-destructive assessment of skin sample tension without the need for contact methods and which should serve as a reliable methodology for not only identifying the material constraints that would be rate determining steps limiting production capacity in the manufacturing process, but could also function as a quality assurance step during the automated manufacturing process. The secondee brings expertise in concept formation and instrument development, as well as a suite of state of the art imaging and peripheral tools for characterisation of the product. On the back of the intended measurements we anticipate translation of the main product towards TRL6, together with broadening of the company portfolio in readiness for entering a market worth an estimated $2B. We include one final comment, from Jean Phillippe Therrien PhD (former head of Biology at Tergus Pharaceuticals and now an Advisory Board member at Ten Bio) that underscores this potential for market exploitation: 'We do not typically purchase ready-to-use products such as those provided by Genoskin because there is nothing that those products do that we cannot do ourselves. However, your product is different. We cannot do what you have been able to do."