Eight Reasons Why the Future of Personalized Medicine will involve 3D-Printed Pharmaceuticals
While I started talking about 3D pill printers nearly ten years ago, today we are seeing incredible breakthroughs in personalized medicine emerging along two fronts:
- Diagnostic Breakthroughs, for example, with genetic, DNA, and molecular testing to uncover possible health threats, suggest optimal treatment pathways, and determine if further specialized tests are needed.
- Intervention Breakthroughs to customize care to the patient and yield a patient-based rather than a one-size-fits-all disease-based treatment protocol.
One of the most exciting and promising developments on the intervention side is the development of 3D-printed (additive manufacturing) pharmaceuticals. The promise for these products lies not only in the conventional manufacturing process but in the possibility of customizing the drugs in areas like dosage and release timing.
The pharmaceutical industry has come a long way from the days of crudely formulated drugs and doctors who basically guess what dosages are right for their patients.
If a particular pharmaceutical comes in the form of a 200 mg pill, doctors will prescribe 200, 400, or 600 mg doses when the right dose for an individual may be 87 mg, 341 mg, or 496 mg. With 3D printing, doctors can be far more precise.
Also, if the patient doesn’t tolerate an important drug well, doctors will have the option of customizing the pill, so the ingredients are released over an extended period of time.
Where We Stand Now
The U.S. Food & Drug Administration (FDA) has already approved the 3D printing of one drug, Aprecia Pharmaceutical’s Spritam, an anticonvulsant medication used for the treatment of seizures. With that approval, industry leaders see the floodgates opening. As 3D printing technology evolves and production costs come down, any pill or capsule that we swallow is now a candidate for this process and this kind of customization.
The FDA has also given preliminary approval to Eli Lilly to partner with Triastek, a Chinese pharmaceutical additive manufacturing company, to explore delivery mechanisms for two of its new medications. The two companies are investigating printed pill shapes and other excipient (non-medicinal) properties that promote the programmed or timed release of the drug’s active ingredients.
In addition to Aprecia and Eli Lilly, three other drug companies, GlaxoSmithKline, Merck, and FabRx, are also actively pushing into this market.
Globally, the market for 3D-printed drugs is predicted to grow by 15% over the next six years, reaching more than $2 billion by 2027.
We’re on the verge of a 3D-printed pharmaceutical industry where precisely measured doses are easy to create and where multiple drugs in varying doses can be combined into a single pill. Flavors and colors will be customized as well.
Eight Advantages of Printed Pharmaceuticals
Personalized health care is clearly one of the primary benefits of 3D-printed oral medications. But I see at least eight additional reasons this technology will be a game changer.
1. Specialized Drugs
It will enable small-batch printing of specialty drugs for rare or “orphan” diseases, the kind of drugs that pharmaceutical companies tend to sidestep due to low volume and profitability. The technology will also be the ideal way to produce small quantities of drugs for clinical trials in which variable doses need to be tested.
2. Reduced Inventory
Hospitals will be able to print specialized and personalized drugs onsite, reducing the need for stockpiling and providing nearly immediate access to specialty drugs they may not have on hand.
3. Local Production Advantages
In addition to hospitals, pharmacies will be in a position to print prescribed drugs for their customers. The distribution process for many drugs will be shortened as we bypass drug wholesalers for many specialized drugs.
4. Shorter Supply Chain
Locally produced 3D-printed drugs won’t be subject to supply chain constraints. Today, many of our drugs are formulated overseas and then packaged there. That equates to a lot of shipping and quality control steps.
5. Workarounds for Disruptions
If a drug manufacturer needs to temporarily close its facility for any reason, 3D printing can fill the supply gap.
6. Improved Drug Safety
Aspects of drug safety can be improved with local production since there will be less opportunity for counterfeit drugs to be introduced into the distribution process. Costs related to maintaining the required documented pedigree of the drug will be reduced as well.
7. Efficient Use of Raw Materials
3D printing of any item, whether it’s a house, pair of shoes, or a pharmaceutical drug, makes far more efficient use of the raw materials involved. Less waste in drug production means far better use of valuable chemical ingredients.
8. Reduced Cost to End User
Most of these benefits – including the shorter distribution chain, reduced expenses for tracking drug pedigrees, less production waste, and localized production – along with continued advances in 3D printing technology, has the potential to significantly reduce the cost of drugs for the end user.
Barriers We Still Need to Overcome with 3D-Printed Drugs
Even though I just painted a rather promising future for this industry, we’ll still need to resolve certain challenges that will come with widespread 3D drug printing.
As with any technological breakthrough, we’ll need to anticipate how 3D drug printing could be abused by bad actors. The technology will enable drug dealers to manufacture illicit narcotics and it could empower counterfeiters to print fake drugs without active ingredients or with the wrong/dangerous ingredients.
Revised Regulatory Processes
We’ll need to revise our drug manufacturing regulatory process, shifting to approving multiple local production sites rather than primary manufacturing plants. The FDA will also need to address matters related to personalized dosing and release profiles. That means regulators will have to focus on additive manufacturing equipment, processes, and quality assurance of the printing ingredients – not a small shift for this large bureaucracy. To their credit, though, the FDA is already working with the National Institute of Standards and Technology to develop guidelines for 3D drug production.
The pharmaceutical manufacturing industry will likely raise regulatory and legal barriers to this widespread practice since it threatens the industry’s markups and monopolies. Some will shift to becoming suppliers of chemical ingredients rather than manufacturers of finished pills and capsules.
Over time, we’ll overcome these hurdles so that the benefits of customized, 3D-printed pharmaceuticals will be available for everyone. The FDA will reach a tipping point so that approvals for these processes and products will become more routine while remaining thorough.
And as we add more and more sensors to our bodies, the linkage between personalized diagnostics and personalized pharmacological treatment will become even closer and … well… even more personalized.