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The Development of Medium- and Large-Scale Sustainable Manufacturing Process Platforms for Clinically Compliant Solid Core Nanopharmaceuticals

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Connecting Europe’s nanomedicine supply chain

An EU-funded project is pioneering new manufacturing processes and better supply chain coordination in the field of nanomedicine. The goal is to bring more targeted and effective treatments to market and to strengthen European expertise in this sector.

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The NANOFACTURING (The Development of Medium- and Large-Scale Sustainable Manufacturing Process Platforms for Clinically Compliant Solid Core Nanopharmaceuticals) project has made significant progress in the processing of glycan-coated gold nanoparticles, to which therapeutic drugs can be attached. The small size of the particles means that they can pass through blood vessels to deliver medicine directly to diseased sites, and are then quickly excreted by the body. “This technology enables you to treat cancer by focusing directly on the cells affected rather than the whole body,” explains project coordinator Areitio Junquera from Midatech Pharma in Spain. “It allows highly toxic drugs to be specifically targeted to and delivered at the tumour cells while sparing normal tissue, therefore reducing side effects and enhancing efficacy. This is more effective and much kinder to patients.” Strengthening the supply chain There is huge potential here. The global nanomedicines market, which includes cardiovascular, anti-inflammatory and oncology applications, is predicted to grow 12.3 % from 2013 to 2019. Nanocarriers like glycan-coated gold nanoparticles are forecast to account for 40 % of the USD 136 billion nanotechnology-enabled drug delivery market by 2021. Nonetheless, scaling up production of nanomedicines has sometimes proved to be a challenge, due in part to a lack of manufacturing capacity and supply chain coordination. Development costs can also inhibit innovative SMEs, which often do not have the necessary in-house resources to take their bright ideas all the way to market. The NANOFACTURING project has addressed these constraints through developing clinically compliant, sustainable manufacturing processes capable of taking products – like glycan-coated gold nanoparticles – from the lab right through to commercial manufacture. “This is a new field, so the first thing we need is agreement with regulators on how nanomedicines should be taken forward,” explains project partner Jerry Cooper from CPI in the UK. “A lot of our work in this project has involved better understanding of how the gold nanoparticles function, in order to help address the safety and regulatory challenges.” A key element of the project involved bringing different elements of the nanomedicines supply chain together, from analytical research and companies expert in chemical synthesis through to innovators in process development and pharmaceutical firms. “These are partners who might not have worked together before,” says Sarah Scarr, another project partner from CPI. “What we found though is that all partners play a vital role in getting nanomedicines to market. It is very difficult for one company, especially an SME, to have all the expertise they need.” Indeed, the NANOFACTURING project, says Scarr, has been critical in demonstrating how SME cooperation can result in commercial progress. “This sort of support is vital,” she says. “Without it, there is a risk that only the major pharma companies will be able to develop these kinds of drugs.” New therapeutic opportunities The NANOFACTURING project has not only strengthened the European nanomedicines supply chain and boosted SMEs; speeding up the delivery of new therapies will also ultimately benefit those most in need. In addition to gold nanoparticles to treat cancer, the project team has been looking into coating nanoparticles with small molecules that act as antiviral drugs to treat viral infections. Overcoming the difficulty of delivering therapeutic agents to specific regions of the brain has also been examined. Most small-molecule drugs fail to cross the Blood Brain Barrier (BBB), which makes it difficult to develop effective drugs for central nervous system disorders such as Alzheimer’s, Parkinson’s and strokes. Nanoparticles capable of delivering drugs across the BBB could bring significant therapeutic benefits, a consideration that is all the more pressing given Europe’s ageing population.

Keywords

NANOFACTURING, nanomedicines, pharmaceutical, drugs, therapeutic, molecule, Alzheimer’s, Parkinson’s, cancer, blood

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