The concept of 3D printing has been around for the best-part of a decade, with many different industries now using the technology. The pharmaceutical industry has not been immune to incorporating the technology, with the FDA approving 3D-printed medical devices in recent years. However, it had to wait until August 2015 before it was fully embraced by the FDA, through the approval of the world’s first 3D-printed drug for human consumption: Spritam Levetiracetam, manufactured by the American pharmaceutical company, Aprecia Pharmaceuticals.
If 3D-printing of drugs takes off as predicted, the pharmaceutical and wider healthcare industries will have to undergo an unprecedented period of innovation and change to adapt to the new challenges that will be faced, the most pressing of which undoubtedly has to be how the technology will be regulated. To say that “this will require some serious thought” is an understatement.
For the first time in over a century, the production of tablets could be produced much closer to the patient, in locations ranging from the patient’s local hospital, doctor’s surgery or pharmacy, to their own printer located in their place of residence. In addition to this, the current “one-size-fits-all” approach to medicine may also become redundant as the personalisation of drugs in terms of appearance, size, dosage and even delivery, inevitably becomes more commonplace.
It is widely believed that the role of pharmacists will change radically over the coming years. At present packets of OTC tablets are stored in pharmacies ready for collection by the patient, but the future could see Doctors handing over algorithms providing information about the molecular blueprints and set of chemical inks needed to print the medicine. Pharmacies may instead become mini factories, stocking filaments of the base product which would then be added to the 3D-printer to create the tablet tailored to the patient’s specific requirements. It is however questionable as to whether pharmaceutical companies will experience any real change. The active ingredients to be used in the 3D-printing technology will still have to be created by large manufacturers, who realistically are the only parties capable of financing the development of new drugs and funding their approval by the regulatory authorities.
However, customising 3D-printed drugs to the extent where the dosage is different each time could prove to be a stumbling block, as the current regulatory mechanisms require known and fixed dosages, previously tried and tested on both animals and humans, to be expressed at the time of submitting evidence to market any given product. But due to the ambiguity surrounding the 3D-printing process, one cannot assume that the product itself will be regulated. Instead, the printer could be regulated as a medical device, to the standards of Medicinal device licence class 1. In this case, the regulators would need to be satisfied that the printers are capable of creating the same product each time, which will require validation.
How this validation can be achieved poses further questions. For example, who would be required to conduct the validation and how often would it need to be carried out? As an alternative measure, quality control could be integrated into the process through hyperspectral imaging, which takes thousands of images at each stage of the products’ development.