September 03, 2019 | Press Release
FabRx, a pharmaceutical company standing at the forefront of 3D printing pharmaceuticals, has successfully completed the world’s first-in-human clinical study using their proprietary PrintletsTM technology. This pioneering step brings the 3D printing of pharmaceutical products closer to the clinic with a promise in shifting pharmaceutical practice towards a personalised patient approach (Figure 1).
The study was a result of a collaboration with researchers from University College London (UCL), University of Santiago de Compostela (USC) and the Clinical University Hospital in Santiago de Compostela. It reports the first time integration of an automated 3D printing system for the preparation of personalised dose of the therapy into a hospital setting. The results of the clinical study were published in the International Journal of Pharmaceutics earlier in August this year and can be found here.
The preparation of personalised doses of isoleucine for children diagnosed with the rare Maple Syrup Urine Disease (MSUD) condition was carried out in the Clinical University Hospital in Santiago de Compostela. MSUD is an inherited metabolic disorder which is treated by following a strict diet with tailored doses of isoleucine and valine supplements that depend on the patients’ blood concentration of isoleucine. As there are currently no efficient pharmaceutical manufacturing techniques to prepare personalised therapies, supplements to treat MSUD are manually prepared in hospitals to provide patients with specified doses that meet their therapeutic needs. However, as MSUD is a life-long condition, the process of extemporaneous preparation is time-consuming and adds huge economic burden on the healthcare provider. Hence, an alternative manufacturing technique that could enable the flexible production of such personalised dosage forms is desirable and expected to enhance patients’ compliance to their treatment (Figure 2).
The new 3D printing system is faster than the manual method and allows the preparation of a blister pack equivalent of one month’s therapy (28 printlets) in less than 8 minutes. After 6 months of monitoring MSUD patients, the study showed that the printlets were as effective as the conventional medication prepared manually in controlling the patients’ blood levels of isoleucine. Furthermore, isoleucine blood concentrations following the administration of printlets were closer to the isoleucine target value with less variation when compared with blood levels achieved by conventional compounded treatment. The ability of the 3D printing system to create printlets with different colours and flavours had a further positive impact in enhancing patients’ acceptability of the treatment.
Maria Luz Couce of Clinical University Hospital said, “There is a real need for new manufacturing systems to prepare personalised medicines. The potential application of the 3D printing for rare diseases are countless and it could help to make the medicines safer and more attractive to children”.
Alvaro Goyanes of FabRx said, “FabRx is delighted to work towards solving problems that are not tackled by traditional Pharma industry. We also very are glad to collaborate with teams with vision and interest to bring 3D printing of personalised medicines a significant step closer to the clinical”.
Founded in 2014 by academics from University College London, FabRx has develop printed medicines and drug-loaded medical devices. The rapidly growing biotech business has a strong belief in the potential of 3D printers to revolutionise the way medicines are manufactured. They have been working at the Advanced 3D Printing Lab at UCL conducting research surrounding 3D printed medicines for more than 5 years and have collaboration with companies, universities and hospitals in Europe, USA and Asia. They have more than 30 scientific articles published and 3 patent applications. They have received £900K Innovate UK project for the development of a 3D printer adapted for innovative pharmaceutical products and have recently introduced a new 3DP technology, direct powder extrusion, to the pharmaceutical field.
The hospital, based in Spain, is the European reference hospital for rare metabolic diseases. Maria Luz Couce is Head of the Paediatrics Section and Director of the Diagnostic and Treatment of Congenital Metabolic Diseases Unit of the Clinical University Hospital in Santiago de Compostela. She leads a group with more than 23 professionals dedicated to inherited metabolic diseases (IMD) and is legal representative of the MetabERN, European Reference Network for Hereditary Metabolic Disorders. María Jesús Lamas Diaz was chief of the Pharmacy Department at Clinical University Hospital in Santiago de Compostela during the study. Recently, she was appointed as the Director of the Spanish Agency of Medicines and Medical Devices.
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