Updated: May 31
What are the regulatory challenges faced by the 3D printing of pharmaceuticals, and how do we overcome them? There is no denying that the future of individualized or customized medications is a significant factor in the growing popularity of 3D-printed pharmaceuticals.
Some of the benefits of 3D-printed pharmaceuticals and why they're becoming so attractive to manufacturing companies include the more straightforward production process, the ability to customize compositions of pharmaceuticals, customized active pharmaceutical ingredient (API) release profiles, and customized therapeutic applications.
It's only the beginning of 3D printing technology in the pharmaceutical industry. However, market research suggests that the 3D-printed pharmaceutical industry is expected to grow by as much as 6% annually in the coming years.
As an industry leader in the 3D printing of pharmaceutical products, Laxxon Medical has uniquely positioned itself as an innovator in the field of 3D printing thanks to its SPID®-Technology.
However, what are some of the regulatory challenges that are being faced by the 3D printing of pharmaceuticals, and how do we overcome them?
Regulatory Challenges In the 3D Printing of Pharmaceuticals
As we continue to see improvements in 3D printing technology, it becomes both more reliable and affordable. However, not everyone can just start 3D printing pharmaceutical products, and there are strict regulations in place to govern how pharmaceutical products are produced.
In the United States, 3D printing in the medical industry is 100% regulated by the FDA. 3D-printed medical products are regulated in three ways:
Medical Devices are regulated by the FDA Center for Devices and Radiological Health (CDRH).
Biologics are regulated by the FDA Center for Biologics Evaluation and Research (CBER).
Drugs and Pharmaceuticals are regulated by the FDA Center for Drug Evaluation and Research (CDER).
Let's look at the regulations governing 3D-printed drugs and pharmaceuticals.
Along with the technological challenges of 3D-printed pharmaceutical products and drugs, companies must also deal with strict pharmaceutical regulations, including that drugs meet current design, manufacturing, and quality regulations.
In 2016, the FDA released a technical guide for 3D-printed medical devices, which indicated that in the future different 3D printing techniques will require a specific set of rules. However, as it stands, the FDA is still assessing 3D-printed drugs and pharmaceuticals and is yet to publicly release a complete set of regulatory guidelines.
If you're interested in learning more about the 3D printing of pharmaceuticals and how it works, check out our article on What Is Medical 3D Printing and How Is It Regulated.
Recently, Laxxon Medical announced that they were partnering with Hovione for the 3D printing of pharmaceuticals that comply with the Current Good Manufacturing Practice (cGMP), which is a process that the FDA set up to ensure medication is manufactured safely by all pharmaceutical companies.
“Laxxon is thrilled to establish a long-term partnership with Hovione,” said Klaus Kuehne, COO of Laxxon Medical. “This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry, thus accelerating our ability to serve our customers.”
“Hovione has a global reputation for their pharmaceutical innovation services, expertise, and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts,” said Helmut Kerschbaumer, Laxxon’s CEO.
“We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics, but it also has the potential to reduce the time and cost of drug development,” says Dr. Jean-Luc Herbeaux, Hovione’s CEO.
It's just another way that Laxxon Medical is expanding the boundaries and potential of 3D printing for the pharmaceutical industry.
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.