EHDA Network-Pharmaceutical EHDA Technology: Developing QbD Facilitated, Continuous and Scaled Therapy Enabling Platforms

Advances in fit for use manufacturing of biopharmaceutical drug delivery and pharmaceutical systems are now required to fit Quality by Design (QbD) models. These current regulations require excellence to be built into the preparation of emerging products (both material and process) thereby leading to product robustness and quality. In addition, industrial needs (economical and reproducible quality enhancement) are driving manufacturing towards continuous processes over batch type processes which also rely on QbD (for integrity and quality). EHDA technology is a robust process that has been utilised in various formats (e.g. electrospinning, electrospraying, bubbling and even 3D printing) and is favourable due to applicability with the development of stable nanomedicines and biopharmaceuticals, the emergence of this technology is clearly evident in the UK and on the global scale. Attempts in scaling up (for suitable pharmaceutical scale) and in tandem with continuous processes (including controlled manufacturing) have been very limited. There also, now, remains a huge void in the adaptation of sensible QbD (multi-variate) for the current methods developed and also those required by industry. While lab scale research continues with the ongoing development of such processes (e.g. nanomedicines, smart and controlled delivery), the transition to industry or the clinic will have to meet these regulations (and scales) for there to be a real impact, which is now, also, an important aspect of grass root research in the UK. The EHDA network brings together specialists from academia and industry to advance this technology through several means. Firstly, initiating developments towards a real-viable scale for Pharmaceutical production. Secondly, to incorporate developments in lean manufacturing and legislation (e.g. continuous manufacturing, online diagnostics, QbD and adaptable scale). Thirdly, to marry optimised lean technologies with novel and emerging macromolecular therapies and actives. The network has a wide range of activities and initiatives which will lead to significant developments (and collaborations) in an area of increasing global interest (EHDA processes) - but currently only on a viable lab scale to date. This network will be the first of its kind and will serve as the central and pioneering hub in this remit.