Skin Metrology for Optimised Automation of the Ten Bio Device Portfolio

“每个人都知道紧张对皮肤健康起着关键作用。终于有人想出了把它融入产品的方法。这是件大事！Jon Volmer博士（Medpharm研究生物学和创新高级总监）评论了目前项目的重点产品。制药和化妆品行业需要先进的皮肤模型，模仿人类皮肤的表现。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（University of Dundee）的一家屡获殊荣的衍生公司Ten Bio提出了一个解决方案，该公司开发了一种独特的平台，该平台将人类皮肤置于受专利保护的紧凑型平台中，并使皮肤保持拉伸状态。以这种方式应用张力不仅可以延长产品的寿命，而且还保留了竞争技术无法比拟的可证明的功能水平，扩展了大量其他应用的潜力，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心。高德美（Galderma）研究部门的退休主管、现任Ten Bio顾问委员会主席布拉罕•施罗特（Braham Shroot）曾（就Ten Bio的TenSkinTM产品）评论道：“在这个领域，还没有这样的产品。”你开发了一项将颠覆市场的技术。这很令人兴奋。“目前，公司主要产品的生产速度缓慢，劳动密集型，每小时约4台。鉴于这一事实，Ten Bio已经与专业的工业产品设计工程师（i4 product design Ltd., (i4PD) Edinburgh）合作，以期实现自动化生产，并且已经确定了与安装和拉伸皮肤到最佳状态相关的瓶颈。这个问题涉及到皮肤复杂的粘弹性行为，本质上提出了一个问题：我们可以多快地拉伸皮肤，在多大程度上，在生产过程中不会对皮肤造成不可逆转的损害？我们相信，这个问题可以通过对Ten Bio现有的张力测试仪器的修改来回答，并增加一个进一步的传感系统，可以直接评估，或以可靠的方式推断，在特定的应变速率下，一组拉伸产生的瞬时张力水平。这里应用的方法涉及使用商业仪器和内部构造的设备对皮肤样品状态进行快速的原位和非侵入性光学传感，这将导致皮肤样品张力的快速远程和非破坏性评估，而不需要接触方法，这应该作为一种可靠的方法，不仅可以识别材料限制，还可以确定制造中限制生产能力的速率决定步骤过程，但也可以作为自动化制造过程中的质量保证步骤。第二个人带来了概念形成和仪器开发方面的专业知识，以及一套用于产品表征的最先进的成像和外围工具。在预期测量的基础上，我们预计将主要产品转换为TRL6，同时扩大公司产品组合，为进入价值约20亿美元的市场做好准备。我们最后引用了Jean philippe Therrien博士（Tergus pharmaceuticals的前生物学主管，现在是Ten Bio的顾问委员会成员）的评论，强调了这种市场开发的潜力：“我们通常不会购买genenskin提供的即用型产品，因为这些产品没有什么是我们自己做不到的。然而，你的产品是不同的。你们所能做的，我们做不到。”

"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."