Welcome to this month’s AM Focus: Medical. For the entire month of February, we are going to zoom in on the many possibilities that additive manufacturing is offering today to medical companies. In this article, we’re giving you a dose of FabRx, a pharmaceutical biotech company that develops pharmaceutical 3D printers and 3D printed tablets. Upcoming articles in the AM Focus will span innovative startups to giant multinational corporations, all of which are using AM in exciting ways. At the end of the month all the best content will be featured in 3dpbm’s Medical AM Focus 2020 eBook.
FabRx, a UK-based pharmaceutical company, uses 3D printing in an unusual way. Established in 2014 by leading academics from University College London, the spinout company specializes in the 3D printing of personalized medicine in the form of “printlets.” These are swallowable tablets capable of containing multiple drugs with precise dosages, controlled release times and a user-defined shape, size, flavor and color. The company says it offers a “truly personalized treatment approach” to patients.
Although it may sound strange, 3D printed medication may solve some serious problems in the pharmaceutical industry. “Conventional medicines production involves the mass manufacture of tablets with a fixed dosage, shape, size and drug release,” explains Sarah Trenfield, Director of Innovation at FabRx. “However, recent findings from NHS England have highlighted that up to 70% of patients do not gain efficacy from the traditional ‘one-size-fits-all’ treatment pathway. This is especially for the elderly and young patients, as well as for certain medicines that require exact tailoring (e.g. narrow therapeutic index drugs).”
FabRx decided that a more flexible system was required in order to deliver truly personalized medical solutions to patients, and found that additive manufacturing provided an exciting possibility in this area. So the company went about developing a “wide range” of 3D printing technologies at its Advanced 3D Printing Labs in London. To date, FabRx has explored the use of seven different types of printers, including extrusion-based, vat polymerization and powder bed systems. All of these systems have been adapted to produce medicines with pharmaceutical-grade excipients.
“To produce formulations using our systems, we follow the three D’s of 3D Printing Pharmaceuticals,” Trenfield explains. “These are 1) Design: The formulation (shape, size and dosage) is personalized according to the requirements of each patient using specially developed pharmaceutical software, 2) Develop: A drug ‘ink,’ a mixture of drug(s) and excipient(s), is prepared and loaded into the pharmaceutical 3D printer, and 3) Dispense: The medicines can be dispensed on demand by a pharmacist at the click of a button.”
Benefits of these 3D printed medications are many and varied. First and foremost, the products can be fully tailored to the patient, with a dosage, shape, size and drug release that suits their condition. FabRx says this personalization serves to maximize “medication adherence, clinical efficacy and safety.” The printlets also offer reduced wastage, point-of-care production (via the portable 3D printing system) and assured quality control.
So how do regulatory bodies feel about 3D printed drugs? According to Trenfield, the company has managed to work closely with regulators to ensure its products are suitable for the market. “Regulation has been a key consideration in the development of our 3D printing systems,” she says. “To ensure the quality of the medicines after printing, we are integrating non-destructive quality control methods into our 3D printers to enable a real-time check of product quality for on-demand dispensing. We are also working closely with regulatory bodies (MHRA, the UK’s Medicines Healthcare and Products Regulatory Agency, and AEMPS, the Spanish Medicines Agency), which has enabled us to best design a 3D printer which will dispense medicines that are safe and effective for patients.”
In 2019, FabRx invented a novel 3D printing system for the production of pharmaceuticals. Known as direct powder extrusion, the system enables the production of drug products directly from powdered materials in a single-step process. Trenfield says the technology “enables flexible and tailored dosing with minimal development times, showing promise in the field of pre-clinical studies or early phase clinical trials.”