Securing 3D Printed Pharmaceuticals
Posted on April 15th, 2022
In 2016 the USA approved the first 3D drug called Spritam (levetiracetam). It is the first 3D-printed drug to receive approval from the U.S. Food and Drug Administration (FDA) and is now being used in pharmacies. 3D printing of this medication provides advantages over traditional tablet production; The tablet maintains rapid disintegration properties even at high dose loads (up to 1,000 mg), a wide range of taste masking capabilities can be provided and printing can be customized for specific unit-doses for precise and convenient administration.
The 3D Printed Drugs market size was worth USD 294.6 million in 2021 and is estimated to reach USD 558.0 million by 2029. This rapidly growing area of additive manufacturing could positively impact healthcare choices for many people.
In February 2021, GlaxoSmithKline partnered with the University of Nottingham on a study “3D Printing of Tablets Using Inkjet with UV Photoinitiation” to produce 3D printed ropinirole tablets to treat Parkinson’s disease. This technology works by printing a mixture of a monomer and a customized drug dosage. Once this is deposited the mixture is cured by shining UV light on it. This creates a customized tablet ready for use.
Since Spirtam was approved, research has been conducted into using fused deposition modeling (FDM), Stereolithography (SLA), Direct Powder Extrusion and Selective Laser Sintering (SLS) for pharmaceutical 3D printing. FabRx launched the M3DIMAKER 3D printer for personalized drug delivery.
Obtaining approval from regulatory authorities is a crucial barrier that may impede the adoption of 3D-printed drugs. Fulfilling demanding regulatory requirements by the FDA and other countries’ regulatory organizations could be a hurdle that may hinder the availability of 3D-printed drugs on a larger scale.
With all this exciting research and development in 3D printed pharmaceuticals we must not overlook the security aspect of printing medications. There have been some overly zealous predictions that having at home 3D pharmaceutical printers is the future but it’s more likely that dedicated service bureaus or medical institutions will take on the task of printing drugs. It is imperative that the systems involved in designing and printing pharmaceuticals are secured from cyber threats. Malicious cyber interference in the production of medication would be a serious problem. Not just for changing drug dosage and drug delivery speed, which could be fatal but there is also the possibility of violating HIPAA in order to steal patient information.
Operational technology (OT) is a continuing and growing target for malicious attacks. The Cybersecurity and Infrastructure Security Agency (CISA) has issued an alert in April 2022 for industrial control system (ICS)/supervisory control and data acquisition (SCADA) devices and has made recommendations including “Leverage a properly installed continuous OT monitoring solution to log and alert on malicious indicators and behaviors.” While pharmaceutical 3D printers may not be currently connected to the Internet, that does not make them immune from cyber threats. The use of any connected device in the printing design and process leaves the whole process vulnerable. As society moves more towards a connected environment, these printers will inevitably become connected. It is important to consider cybersecurity factors and the need for continuous cyber monitoring when designing 3D printers and not just as an add on after production. BPL’s BISON tool continuously monitors the additive manufacturing process, giving the user notifications of anomalous incidents in the printing process.
If you are interested in learning more about securing AM or a demonstration of the BISON capability, please contact us at info@breakpoint-labs.com
