The Future is Now: How 3D Printing Could Deliver Personalized Medicine

“It will take a few minutes to upload the instructions for your prescription to the 3D printer. We will call you once your medication is ready to be picked up.”  While it seems like science fiction, your pharmacist may describe filling your prescription using this emerging technology sooner than you might think. In this blog post, I’ll discuss how 3D printing of drugs in concert with biosimulation technology could accelerate the move towards personalized medicine.

The emergence of precision medicine

The era of precision medicine has arrived. The increased focus on disease prevention and treatment strategies that account for individual variability in genes, environment, and lifestyle is exemplified by government programs such as the Precision Medicine Initiative, which was unveiled at this year’s State of the Union. This program will use proteomics, metabolomics, genomics, and bioinformatics methods to characterize patients and better understand the mechanisms of disease. Ultimately, the knowledge gained will inform clinical practice and support the use of optimal therapies for each patient.

The concept of accounting for individual variability is central to our use of biosimulation technology for drug development. One example of this is the notion of personalized drug dosing. Virtual Twin™ technology will be an important step towards making this vision a reality. The idea is to match the characteristics of a real patient with his or her virtual twin in order to predict individual risk of complex drug-drug interactions (DDIs). This matching will happen at several levels:

  • Age, weight, height, sex, and ethnicity
  • Current drug dosage and co-medications
  • Activity of metabolic enzymes and transporters
  • Level of organ function

The insights gleaned from biosimulation combined with customizable formulation via 3D printing stand to create a new paradigm for how medications are given to patients.

3D printing and its application to health care

3D printing uses a computer-controlled printer to lay down successive layers of material to create the 3D model. The biomedical applications of 3D printing have become a hot topic in recent years. For example, 3D printing has been using to create a number of artificial, lab grown tissues including human bladders, vaginas, and most recently, heart cells.

What’s more, this new technology is poised to revolutionize the pharmaceutical industry. Last month, the FDA approved the first 3D printed drug, Aprecia Pharmaceuticals anticonvulsant, SPRITAM® (levetiracetam). This new formulation offers several advantages compared to conventionally produced medications. First, the 3D printed drug quickly dissolves in a small drink of water. It is easy to imagine how the ability to quickly get therapeutic concentrations of an anticonvulsant on board would benefit a patient who was having seizure, perhaps in a public setting where intravenous delivery of medications isn’t feasible. In addition, by using a 3D printer, the pill can be produced with higher doses than normal pills. Again, this could help with medication adherence if patients can take one pill a day rather than several times a day.

Custom dosing using 3D printing

The ultimate use for this technology in individualized dose optimization. This would confer a major benefit to patients taking medications with complex pharmacokinetics (PK). One such example is tacrolimus, a widely used immunosuppressant for both adult and pediatric solid organ transplant recipients. Tacrolimus has a narrow therapeutic index and significant inter- and intra-individual PK variability. In addition, it has highly variable oral bioavailability due to extensive pre-systemic metabolism by CYP3A and uptake by P-glycoprotein transporters.

To ensure graft survival, it is essential to optimize the dose of tacrolimus for individual patients. The standard of care has been therapeutic drug monitoring wherein trough concentration (Ctrough) has been used to guide tacrolimus dosing. There is an urgent need for alternative strategies for estimating tacrolimus exposure as the relationship between Ctrough and organ rejection is controversial. My colleagues at Certara developed an optimal sampling strategy (OSS) using maximum a posteriori Bayesian estimators (MAP-BE) to provide an accurate method for predicting tacrolimus exposure in pediatric liver transplant patients. This OSS will support designing prospective clinical trials aimed at determining the drug’s therapeutic window in this population.

In the not too distant future, I envision the convergence of two powerful emerging technologies: biosimulation and 3D printing. The former would be used to identify to ideal dose for each patient, and the latter could be used to print pills ad hoc that deliver the right dose in a single, easy to administer, once daily pill.

All information presented derive from public source materials.

Watch this TED talk video

You can learn more about the numerous potential pharmaceutical applications for 3D printing in this short TED talk video. The featured speaker, Dr. Lee Cronin of the University of Glasgow, discusses how eventually we may be able to print our own medicine using chemical inks.

Learn more about how modeling and simulation will enable personalized medicine

Today, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily. Our CEO Dr. Edmundo Muniz discusses this trend in an article published in Clinical Researcher. I hope that you’ll read it and let me know what you think in the comments section!