NANOFACTURING: Medium- and large-scale manufacturing platforms for clinically compliant nanopharmaceuticals

Development of medium- and large-scale sustainable manufacturing process platforms for clinically compliant solid core nanopharmaceuticals

GalChimia, Applus+ Laboratories, Midatech, Prochimia, the Centre for Process Innovation (CPI), and three Academic groups have participated in the research project entitled “NanoFacturing – The Development of Medium- and Large-Scale Sustainable Manufacturing Process Platforms for Clinically Compliant Solid Core Nanopharmaceuticals”.

The main objective of the project is to develop a new manufacturing platform process for solid core nanopharmaceutical products, capable of being scaled up to supply Phase III trials and beyond, which is cost-effective, safe, efficient, robust, and regulatory compliant. GalChimia has been specifically involved in the synthesis of the ligands used to bind the nanoparticles to other chemical or biological molecules. The project has been financed by the European Union through the Horizon 2020 programme.

Project Summary

Project execution: February 2015 to January 2019

Project budget: 8,341,908 EUR

Status: Completed

Tackling the problem: Lack of pilot manufacturing capacity and supply chain infrastructure:

• There are currently a wide range of nanopharmaceutical products in development across Europe, however very few nanomedicines have been manufactured.
• The quantities required for clinical testing studies are modest, from 10 to 100 grams, but it does not fit easily into existing manufacturing plants.
• Many innovative SME’s do not have the resources to carry out the testing they need.
• The development, scale up and manufacturing infrastructure and supply chain is not in place, or accessible.
• A greater understanding of how nanomedicines work within the body is required to navigate through a complex regulatory environment.

The project focused on the scale up of glycan-coated gold nanoparticles, the latest generation of nanomedicines, and has designed and built pilot manufacturing facilities for the production of nanopharmaceuticals being developed in Europe. It aimed to address the small and medium-scale needs of early phase clinical trials and niche applications, to tackle the bottlenecks in the delivery of these medicines to the market. Furthermore, it supports later stage products with large potential markets, by developing clinically compliant, and sustainable, large-scale manufacturing processes capable of taking these products through to commercial manufacture and supply.

Project Outcomes:

The Nanofacturing project has successfully combined experts from a number of European organisations to develop an open-access pilot line, for use by companies throughout Europe, and a commercial batch process that operates under sterile conditions together with specialist analytical capability and custom ligand synthesis.

GalChimia led one of the work packages of the project, aimed to the scale up of ligand manufacture and the synthesis of new ligands to enhance and expand the applications of the gold nanoparticles. The goals of the work package have been achieved, with the successful synthesis under GMP conditions of the two initially selected ligands and the preparation of new compounds in quantities of hundreds of grams.

Comunication and Dissemination

• Poster Design and Synthesis of Linkers for Glycan Coated Gold Nanoparticles Used in Drug Discovery presented at RICT (Nantes, 2019), EFMC-ASMC (Athens, 2019), EFMC-ISMC (Virtual event, 2020), #RSCPoster Twitter Conference (Virtual event, 2020) and EFMC-ISMC (Virtual event, 2021).

GalChimia thanks all the partners in the Nanofacturing project for their involvement and teamwork, which have been key to the success of the project.