The 3D printed medicine supply chain is a regulatory challenge
The challenge: Doctors hope to someday use 3D printers to deliver precise, personalized doses of drugs to increase efficacy and reduce side effects for patients.
A few 3D printed drugs are already available, but their widespread use may still be a long way off. Some researchers claim that 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 determining how to monitor a supply chain that will be totally different from the traditional drug manufacturing process.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is developing a new framework to regulate medicines manufactured in healthcare facilities. This includes 3D printing and offers a glimpse of how this system might work.
“If you think of the drug legislation as a house, we don’t overthrow and rebuild it,” Ian Rees, director of the MHRA’s Inspectorate Strategy and Innovation Unit, said during a webinar in June. “The house is perfectly fine; what we do is put an extension on it.
The process: Printers manufacture drugs by depositing many layers of a drug raw material to form a pill. The process is much slower than traditional manufacturing, sometimes by orders of magnitude, but it can have other benefits.
Shen Qi, a researcher at the University of East Anglia who studies 3D printing, is evaluating techniques that allow printers to combine multiple drugs into a single pill, which could make it easier for patients to stick to their drugs. medications.
“It is not intended as a substitute for tablet making and capsule filling. It’s not for the general population, not for colds and coughs, ”she told FreightWaves. “It’s for special patients who would benefit from personalized dosing, personalized combinations of drugs.”
Additionally, she said 3D printers could deliver patient-specific doses, which could reduce side effects. Traditional manufacturers are only allowed to produce a few fixed doses.
Pass: 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 at centralized manufacturing sites that have received typical FDA approvals. Although the technology is new, the production system resembles more traditional approaches.
The effect: Personalization of drugs for specific patients would move the final stage 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 works with Qi, said this type of decentralized manufacturing network could make the supply chain more flexible.
“It’s good to have a traditional flow of tens of thousands of tablets per day, but if that place is in India or China, then there is a big downside in the supply chain.” Harrinton told FreightWaves.
However, 3D printers would still depend on drug raw materials to make custom drugs. There are several types of raw materials, including powders, filaments and granules. It is still unclear which raw materials will become the most common or who will manufacture them.
Qi said that one possibility is that the big pharmaceutical companies manufacture the raw materials in centralized facilities.
“They can formulate them and produce them. These become an intermediate product, and then the localized and decentralized manufacturing center will absorb these raw materials, ”she said.
If so, 3D printed drugs would still be tied to centralized manufacturing facilities, but there are still situations where the technology would provide more flexibility.
Rees of the MHRA said the agency recently received a request from a group of researchers about developing technology to deliver medicine to astronauts en route to Mars.
“If you’re an astronaut on a three-month trip, you’re not going to go back to pharmacists for a few headache pills or antibiotics,” he told a webinar. “You’re either going to take them with you or make them there.”
The obstacles : One of the big challenges in the 3D printed medicine supply chain will be keeping an eye on all the small printers in hospitals and doctor’s offices. This process does not fit easily into the current regulatory system.
In March, the MHRA released a draft showing how it could regulate a supply chain for 3D-printed drugs and other point-of-care drugs, such as certain cell and gene therapies.
“As with all other laws, they come at some point. They are perfect for incremental type innovations. But if you’ve got something transformative and disruptive innovation, that’s not right, ”Rees said. “That’s what the disruption means. Things will have to change.
The overview 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 that oversees them.
The monitoring site should ensure that the printers are functioning properly and report any problems. The MHRA would focus its regulatory efforts on this inspection site, but would also perform inspections on individual printers.
Now, the MHRA plans to seek public comment on this proposal. The agency will refine the plan on the basis of these comments and Parliament will debate the merits of the proposal.
In addition to regulatory issues, another major challenge will be ensuring that healthcare providers are comfortable using this technology.
FabRx, a company that makes 3D printers designed to produce drugs, recently launched a clinical trial that will give cancer patients pills with a personalized dose of cancer treatments and anti-side effect drugs.
In addition to testing the effectiveness of the personalized pills, FabRx formulation scientist Anna Worsley said the trial will test whether hospitals can successfully integrate printers into the patient care workflow.
“It will really help us develop the operating procedure for individual printing in a hospital,” she told FreightWaves.
And after? Julian Quodbach, a researcher studying 3D printing at German University Heinrich Heine in Düsseldorf, said he believes personalized doses of drugs will become an important part of medicine. But at the moment it is far from common.
“We are creating the techniques that will be used in the future to create individualized dosage forms, but we understand that they will only be needed in the future,” he told FreightWaves. “It’s really a parallel development.
Worsley said she doesn’t think 3D printing will ever replace widely used basic drugs without major issues, such as ibuprofen or acetaminophen.
She believes the technology will likely serve people with rare diseases first, but eventually become more common for people taking multiple medications.
“It will be a slow and gradual process,” she said. “But we predict that 3D printing in the long term future, even more than 10 years, will be available for most drugs.”