Group of seven partners is establishing a pilot line for the production of nanomedicines.

The Nanofacturing Consortium, comprising eight organizations including Midatech Pharma, the Centre for BioNano Interactions (CBNI), École Polytechnique Fédérale de Lausanne (EPFL), ProChimia Surfaces, Applus + Laboratories, IRCCS — Institute for Research and Health Care, GalChimia, and the Centre for Process Innovation (CPI), was organized by Midatech to develop and implement scaled manufacturing solutions for the production of glycan-coated gold nanoparticles for medical applications.

The EU-based group recently announced that it is constructing a pilot-scale production line and in the process of designing a commercial-scale plant.

The goal of the project is, by working in collaboration, to reduce the cost of establishing a multiple-scale manufacturing platform for the production of nanopharmaceuticals currently being developed in Europe. The project is expected to be completed in 2019.

It is thought that nanoscale drugs have the potential to be more effective while also having reduced side effects. Drugs based on gold nanoparticles can pass through cell membranes and pores, thus allowing both the delivery of active drug substances to targeted sites of action and rapid clearance from the body. By binding active pharmaceutical ingredients (APIs) to gold nanoparticles, it is, therefore, possible to achieve targeted delivery, even with those APIs that have low solubility and poor pharmacokinetics.

Developing economical and scalable technology for the production of pharmaceutical-grade gold nanoparticles has been a challenge, however. In particular, the lack of pilot manufacturing capacity and appropriate supply-chain infrastructure has slowed the scale-up of promising drug candidates

Members of the Nanofacturing Consortium are addressing the need for the supply of ligands, pilot-scale gold nanopharmaceutical batch manufacturing capacity, nanoparticle characterization techniques and commercial scale-up facilities.

• Midatech is working with the European Nanomedicine Characterization Laboratory (EUNCL) to develop testing methods for use in nanoparticle development as part of the Hepato Cellular Carcinoma Project. Midatech Pharma España has also completed the installation and commissioning of a new aseptic isolator and robotic filling and finish system in its new Aseptic Manufacturing Suite.
• CBNI-UCD is studying the correlation between the structural properties of gold ultrasmall nanoparticles and their interactions with human cells and organs to identify features essential for the development of safe nanoparticle-based drugs and has developed an analytical technique specifically for this purpose.
• Researchers at EPFL have developed techniques for characterizing pure nanoparticles and nanoparticle-protein interactions.
• ProChimia Surfaces has developed synthetic routes to different ligands for use in nanoparticulate medicines  and is evaluating their scalability for commercialization.
• IRCCS has prepared and characterized two biocompatible nanoparticles with proposed antiviral properties and is presently conducting in-vitro testing of their anti dengue properties.
• Applus + Laboratories has developed optimized and scalable synthetic routes for ligand production that can be performed according to GMP standards.
• CPI has developed a scalable process for the production of purified, active conjugates of gold nanoparticles. It has also made progress in establishing a pilot production line for the continuous manufacture of gold nanoparticles. It is now focusing on the production of a wider range of GNP-Active conjugates that can be manufactured on the new pilot line.
• GalChimia has developed ligands and will pursue their commercialization in conjunction with Applus + Laboratories.

“We are delighted to announce that the project is progressing so well. The development of processes for the scale up of Nanofacturing’s innovative platform technology and the knowledge and capability being developed by each of the partners, will enable the consortium to be at the forefront of the rapidly growing nanopharmaceutical sector,” said Dr Jerry Cooper, Nanofacturing Project Manager for CPI.