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。最后，有人想出了如何将其融入产品中。这可是大事Jon Volmer博士（Medpharm研究生物学和创新高级总监）评论了本项目的重点产品。制药和化妆品行业需要模拟活体人类皮肤性能的高级皮肤模型。由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。来自邓迪大学的获奖衍生公司Ten Bio已经提出了一个解决方案，该公司开发了一个独特的平台，该平台在受专利保护的紧凑平台内使用人类皮肤，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增加了产品生存能力的寿命，而且还保留了竞争技术无法匹配的可证明的功能水平，从而将潜力扩展到过多的额外应用，包括预测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行业对其潜力的好奇心。因此，布拉汉姆Shroot，在Galderma的研究退休负责人，现在的顾问委员会主席，以十生物，评论[关于十生物的TenSkinTM产品]："有没有这样的领域。你开发了一项技术，将扰乱市场。太令人兴奋了。"目前，该公司主要产品的生产速度缓慢，劳动密集型，每小时约4个单位。鉴于这一事实，Ten Bio与专业的工业产品设计工程师（i4 Product Design Ltd.，（i4 PD）爱丁堡），以期实现制造自动化，并发现了与将皮肤安装和张紧到最佳状态的步骤相关的瓶颈。这个问题涉及到皮肤的复杂粘弹性行为，并基本上提出了一个问题：我们可以拉伸皮肤的速度有多快，拉伸到什么程度，而不会在生产过程中不可逆地损坏它？我们相信，这个问题可以通过修改Ten Bio用于拉伸测试的现有仪器来回答，并增加一个进一步的传感系统，该系统可以直接评估或以可靠的方式推断出在特定应变率下设定拉伸产生的瞬时张力水平。这里要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本的状态进行快速原位和非侵入性光学感测，这将导致对皮肤样本的状态进行快速远程和非侵入性光学感测。皮肤样品张力的破坏性评估，而不需要接触方法，并且其应作为可靠的方法，不仅用于识别将是速率确定步骤限制的材料约束，这不仅可以提高制造过程中的生产能力，而且还可以在自动化制造过程中用作质量保证步骤。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，我们预计主要产品将转向TRL6，同时扩大公司产品组合，准备进入一个价值约20亿美元的市场。我们包括最后一条评论，来自Jean Phillippe Therrien博士（Tergus Pharmaceuticals的前生物学负责人，现在是Ten Bio的顾问委员会成员），强调了这种市场开发的潜力：“我们通常不购买即用型产品，如Genoskin提供的产品，因为这些产品没有什么是我们自己做不到的。但你的产品是不同的。我们不能做你能做的事。"

"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."