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

这项奖学金申请旨在加速制药行业对连续和添加剂制造的接受。连续制造被广泛应用于许多行业，在这些行业中，准时制协议是常见的。随着打印机商业化，包括3D打印在内的附加制造最近受到了极大的关注。加法制造是一种非常灵活的工艺，目前主要用于原型制造，从而实现产品的个性化。然而，扩大添加剂制造工艺是具有挑战性的，经常建议横向扩展(多台打印机或打印头)的愿景。相比之下，连续制造流程提供了一条更直接的扩大规模的途径，而且也很灵活；同一条生产线可以用来生产许多不同的产品。然而，连续制造中的质量保证协议是具有挑战性的。制药业没有采用最新的制造技术的原因很多，其中最主要的是监管方面的担忧。这在一定程度上是由于监管机构与生俱来的保守主义(尽管FDA正在鼓励变革)，但也是因为缺乏与连续制造生产线整合的分析技术，以确保产品质量。本奖学金旨在解决这些分析方面的挑战。

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.