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Medically NecessaryNews

Supply chain for 3D-printed drugs is a regulatory challenge

Tech still has a long way to go

This is an excerpt from Medically Necessary, a health care supply chain newsletterSubscribe here.

The challenge: Doctors hope to one day use 3D printers to provide precise, personalized doses of drugs to increase efficacy and reduce side effects for patients. 

A few 3D-printed drugs are already available, but widespread use may still be a long way away. Some researchers say 3D printing has the potential to shorten supply chains for certain drugs, making them more flexible and resilient.

As engineers work to perfect the technology, regulators are simultaneously sorting out how to monitor a supply chain that will look totally different from the traditional drug manufacturing process. 

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new framework for regulating drugs manufactured in health care settings. That includes 3D printing and offers a preview of how this system could work.

“If you imagine medicines legislation as a house, we’re not knocking it down and rebuilding it,” Ian Rees, the manager of MHRA’s Inspectorate Strategy and Innovation Unit, said during a June webinar. “The house is perfectly fine; what we’re doing is we’re putting an extension on it.”

The process: Printers make drugs by depositing many layers of a drug feedstock to form a pill. The process is much slower than traditional manufacturing, sometimes by several orders of magnitude, but it can have other advantages. 

A small 3D printer makes a tablet in an FDA research office. (Photo: FDA)

Shen Qi, a researcher at the University of East Anglia studying 3D printing, is evaluating techniques that allow printers to combine multiple medications into a single pill, which could make it easier for patients to stick with their drugs. 

“It’s not intended to replace tableting and capsule filling. It’s not for the general population, not for cold and cough,” she told FreightWaves. “It’s for special patients who would benefit from personalized dosing, personalized combinations of drugs.”

In addition, she said 3D printers could provide patient-specific doses, which might reduce side effects. Traditional manufacturers only have approval to produce a few fixed doses.

Backstory: The Food and Drug Administration has already approved drugs made with 3D printing. The FDA approved the 3D-printed epilepsy drug SPRITAM in 2015.

However, SPRITAM is produced in centralized manufacturing sites that received typical FDA approvals. While the technology is new, the production system resembles more traditional approaches.

The effect: Personalizing medications for specific patients would move the final step of manufacturing from a few centralized factories to a network of many printers located near patients. 

Tomas Harrington, a professor of operations management at the University of East Anglia who is collaborating with Qi, said this kind of decentralized manufacturing network could make the supply chain more flexible. 

“It’s well and good having a traditional throughput of tens of thousands of tablets per day, but if that location is in India or China that’s when there’s a big supply chain disadvantage,” Harrinton told FreightWaves.

However, 3D printers would still rely on drug feedstocks to make personalized medications. There are several types of feedstocks, including powders, filaments and pellets. It’s still not clear which feedstocks will become the most common or who will make them.

Qi said one possibility is that large pharmaceutical companies will make the feedstocks at centralized facilities.

“They can formulate and produce them. Those become an intermediate product and then the localized, decentralized manufacturing hub would take in those feedstocks,” she said.

If that’s the case, 3D-printed drugs would still be tied to centralized manufacturing facilities, but there still are situations in which the technology would offer more flexibility.

MHRA’s Rees said the agency recently received an inquiry from a group of researchers about developing technology to provide medications for astronauts en route to Mars.   

“If you’re an astronaut on a three-month journey, you’re not going to get back to the pharmacists for a few headache tablets or antibiotics,” he said during a webinar. “You’re either going to take them with you or manufacture them there.”

The hurdles: One of the big challenges for the supply chain of 3D-printed drugs will be monitoring all the small printers in hospitals and doctors’ offices. That process doesn’t fit easily into the current regulatory system.

In March, MHRA published a rough outline showing how it might regulate a supply chain for 3D-printed drugs and other medicines produced at the point of care, such as some cell and gene therapies.

“As with all other pieces of legislation, they’re at a point in time. They’re fine for incremental-type innovations. But if you’ve got something transformative and a disruptive innovation, it doesn’t fit,” Rees said. “That’s what disruption means. Things will have to change.”

The outline suggests that a physical control site could monitor a network of decentralized manufacturing sites, such as individual 3D printers. The organization operating the manufacturing sites would also operate the control site overseeing them.

The control site would have to ensure printers are operating properly and report any issues. MHRA would focus its regulatory efforts on that control site but would also conduct some inspections on individual printers. 

Now, MHRA plans to collect feedback from the public on this proposal. The agency will refine the outline based on those comments and Parliament will debate the merits of that proposal.  

In addition to the regulatory questions, another major challenge will be making sure health care providers are comfortable using this technology. 

FabRx, a company that makes 3D printers designed to produce drugs, recently started a clinical trial that will give cancer patients pills with a personalized dose of cancer treatments and anti-side-effect medications. 

In addition to testing the effectiveness of personalized pills, FabRx formulation scientist Anna Worsley said the trial will test whether hospitals can successfully incorporate the printers into the workflow of patient care.

“It will really help us develop the operating procedure when it comes to individual printing in a hospital,” she told FreightWaves. 

What’s next? Julian Quodbach, a researcher studying 3D printing at Germany’s Heinrich Heine University Düsseldorf, said he believes that personalized doses of medications will become an important part of medicine. But right now it’s far from common.

“We’re creating the techniques that will be used in the future to create individualized dosage forms, but we understand that they’ll be required only in the future,” he told FreightWaves. “It’s really a parallel development.”

Worsley said she doesn’t think 3D printing will ever replace basic drugs that are widely used without major issues, such as ibuprofen or acetaminophen.

She believes the technology will probably first serve people with rare diseases, but that it will eventually become more common for people taking multiple medications.  

“It will be a slow, gradual process,” she said. “But we do see 3D printing in the long-term future, even longer than 10 years, being available for most drugs.”

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