Foresight Fellowship in Manufacturing: Analytical technologies in continuous and additive manufacturing

该奖学金申请旨在加速制药行业对连续和增材制造的吸收。连续制造广泛应用于许多部门，在这些部门中，准时制协议是常见的。随着打印机的商业化，包括3d打印在内的增材制造最近受到了广泛关注。增材制造是一个非常灵活的过程，目前主要用于原型制造，实现产品的个性化。然而，扩大增材制造工艺是具有挑战性的，并且经常建议扩大规模（多台打印机或打印头）。相比之下，连续制造工艺为扩大规模提供了更直接的途径，而且也很灵活；同一条生产线可以生产多种不同的产品。然而，连续制造中的质量保证协议具有挑战性。制药行业不采用最新制造技术的原因有很多，其中最主要的是监管方面的担忧。这部分是由于监管机构固有的保守主义（尽管FDA鼓励改变），但也是由于缺乏与连续生产生产线集成的分析技术，以确保产品质量。本奖学金寻求解决的正是这些分析性的挑战。

This Fellowship application seeks to accelerate the uptake of continuous and additive manufacturing in the pharmaceutical industry. Continuous manufacturing is widely used in many sectors, where just-in-time protocols are common. Additive manufacturing, encompassing 3D-printing, has received much attention recently as printers have become commercially available. Additive manufacturing is a very flexible process and is currently used predominantly for prototype manufacture, enabling personalisation of products. However, scaling-up additive manufacturing processes is challenging and the vision of scales-out (multiple printers or print heads) is often suggested. In contrast, continuous manufacturing processes offer a more direct route to scale-up and are also flexible; the same production line can be used to manufacture a number of different products. However quality assurance protocols in continuous manufacturing are challenging.Many reasons are given for the pharmaceutical industry not adopting the latest manufacturing technologies, chief among these are regulatory concerns. This is in part due to innate conservatism from the regulators (though the FDA is encouraging change) but also due to a lack of analytical technologies being integrated with the continuous manufacturing production lines to ensure product quality. It is these analytical challenges that this Fellowship seeks to address.