Abstract

A number of nanomedicine formulations have enabled, or been shown to hold considerable potential for enabling more effective and less toxic therapeutic interventions. However, progress to date in translating these initiatives to commercial success has been limited. One of the main reasons for this bottleneck is due to the inability of researchers and stakeholders to manufacture batches of the nanomedicine product at the required scale and according to Good Manufacturing Practice (GMP) requirements. The NANOFACTURING project will focus on - facilitating access to required infrastructures and expertise - creating GMP pilot lines for up-scaling manufacturing - addressing the current developmental and production gaps - taking nanomaterials already successfully produced at proof-of-concept/milligram levels and facilitating their scale-up to sub-kilogram quantities - providing large-scale and GMP production for clinical trials and nanomedicine translation. The NANOFACTURING project, through a consortium of 9 partners, will develop the synthetic processes, process control methods, analytical assays for QA/QC, functional specifications, and best practices, interfacing existing R&D centres of excellence, transfer organisations and private GMP manufacturing facilities (including SMEs) to ensure efficient translation from discovery through to first in man, proof-of-concept studies and beyond to Phase III according to industrial and regulatory standards. Specifically, the NANOFACTURING project aims to create a platform process for early, mid- and large-scale manufacturing of glycan-coated gold nanoparticles (GNPs), a widely researched and developed class of self-forming nanoparticles. The ability to engineer new nanopharmaceuticals based on this patent protected platform technology, developed by Midatech Biogune S.L. (Project Coordinator), will have inherent advantages over existing treatments for multiple therapeutic areas.