Event Recap: 3D Printed Pharmaceuticals

It’s the dream: fabricating whatever pill a patient needs, anywhere you want, and just in time. And even though it’s been over 10 years since the last (and only) FDA-approved 3D-printed drug was introduced, innovators aren’t giving up on making this dream a reality. At our latest 3DHEALS event, we looked at why this application of 3D printing (3DP) continues to hold high hopes from four leaders in the field. Three incredible printing systems were discussed, focusing on leveraging 3DP’s ability to create personalized compound drugs using room-temperature paste extrusion, blister/capsule filling, and other cutting-edge technologies. We’re also exploring the regulations and metrology standards, paving the way for reliable, decentralized manufacturing at pharmacies worldwide. Here’s the recap, with the recording now live on 3DHEALS courses.

FABRX: Open Science and Clinical Impact

In 2014, there was considerable skepticism about printing medicines in hospitals. Now, Dr. Alvaro Goyanes, CEO and Co-Founder of FABRX, described how his company has been involved in over 30 clinical trials at various hospitals, published the first article describing a 3D printer being implemented at a community pharmacy, and is even looking to send pharmaceutical 3D printers into space.

FABRX is designing its M3DIMAKER system, a printer with semi-solid extrusion, fused deposition modeling, and direct powder extrusion capabilities for printing custom polypills. These compounded drugs are intended to eliminate the need for patients to take a laundry list of drugs by combining them into a single medication, improving consistency among patients in following their prescription.

What’s truly remarkable about the company is its scale of published scientific research and clinical collaboration. Enthusiasts interested in drug 3D printing should check out the science that FABRX has shared over the years. For example, Dr. Goyanes and colleagues describe the methods and results behind printing single-dose capsules that combine a breast cancer hormonotherapy with an antidepressant, all within a hospital setting for a clinical trial. And they’ve explored the realms of combining printing with AI, fabricating flavored chewables for greater acceptance among pediatric patients, and creating spectroscopic QC methods for consistency and reliability.

This pioneering research has fostered strong clinical collaborations for the company, and it’s raising awareness that 3DP for pharmaceutical applications isn’t slowing down anytime soon. One major hurdle for the field is convincing pharmacists and healthcare providers that 3DP is a worthwhile method for creating these medications. FABRX’s open science and sharing of tangible clinical implementations serve as key markers of progress for the field, increasing confidence that 3DP will yield tangible benefits for patients and accelerating its adoption.

And where 3DP can really shine is in the creation of novel geometries unimaginable by traditional manufacturing methods. 3DP has the flexibility to fabricate drugs of widely varying porosities, multi-material shells for timed therapeutic release, and expandable/detachable structures for controlled retention. However, it’ll be hard for this next generation of geometrically complex, targeted drugs to be accepted if skeptics still perceive 3DP as too nascent for clinical translation. Companies such as FABRX are leading the much needed charge to communicate scientific discoveries and successes widely, showing that reliable, clinically-relevant 3DP is in the here and now.

Craft Health: Inspiration for the Point of Care Era

3D printing provides the ability to tune drug dosage levels for pediatric patients and provide a low-cost solution for smaller scale drug production, such as personalized medicines. However, none of this is worth it if pharmacists must invest time into fiddling with the technicalities of 3D printing, such as fine-tuning printing parameters.

Dr. Seng Han Lim, Technical Co-Founder & Chief Operating Officer at Craft Health, described how they’ve focused on making 3D printing as easy as possible for pharmacists with no prior experience in 3DP. The CraftMake printer is controlled by their software, which calculates recommended formulations, provides templates, and offers a streamlined way for pharmacists to press a few buttons and receive the intended result. The company offers CraftBlends, or standardized pre-mixed inks that don’t require heating or UV curing, eliminating guesswork around choosing the right material for the job.

The ease of adapting to a new workflow is really what can make or break a platform. Intuitive user interfaces, clear indications of when 3DP will be beneficial or not, and guardrails in place to detect when things will fail are essential for a smooth implementation. Nevertheless, troubleshooting printing issues won’t be easy for pharmacists in decentralized locations, hiring additional staff to maintain printers in smaller communities might be a challenge, and there will inevitably be drugs that pharmacists want to use with the printers that don’t yet have validation or QC measures in place.

It’s still encouraging to see that pharmaceutical 3DP companies such as Craft Health are investing heavily in creating robust platforms that anticipate potential pain points. And it’s an approach that many other areas of healthcare 3DP can take inspiration from. For example, many companies are becoming increasingly interested in using AI to automate processes in decentralized locations. Yet, we need guardrails for detecting when the system will fail and clear indications on how best clients can use AI to accelerate their current pipelines. Making the user experience as simple and foolproof as possible is key, and Craft Health is putting it at the top of their list.

CurifyLabs: Paths Forward in Regulation and Decentralization

Founded in 2021, CurifyLabs has already made incredible strides with their Pharma Printer 1, which can dose chewable tablets, capsules, suppositories, and liquids in seconds. Dr. Niklas Sandler, Founder and CTO at CurifyLabs, described how the company has made significant progress with introducing their printer in the US and Europe.

The company has recently collaborated with St. Jude Children’s Research Hospital to test the fabrication of custom hydrocortisone dosage forms to make it easier to administer the medication to pediatric patients. They’ve also worked with Tartu University Hospital in Estonia to print low-dose aspirin tablets that would have been otherwise hard to obtain for patients with aspirin hypersensitivity.

On top of successful use cases, there’s much to be optimistic about on the regulatory side. Dr. Sandler predicts that there won’t be as many regulatory barriers as it may seem, especially since they are printing dosage forms already described in pharmacopeias. He also points out that the pharmacopeias allow for tablets to be produced through extrusion, which includes 3D printing. So the message is to really push on: existing standards have set the stage for 3D printing to make its mark in pharmaceuticals, enabling disruptive change without large uncertainties from completely unpredictable novel products.

And because predictability is embedded in their system, Dr. Sandler described that the company can design formulations that a customer requests and add them to their software library for anyone to use as a template and recreate on their own printer. Companies such as CurifyLabs have a tremendous opportunity to create networks among seemingly disparate pharmacies across the world, enabling them to share new 3D printing settings to accelerate production. While the goal of 3D printing may be to decentralize, 3DP has a strong history of bringing people and expertise together, and innovators are in a position to facilitate the sharing of novel use cases through their platforms to benefit all.

NIST: Where Pharmaceutical 3D Printing and Metrology Meet

Dr. Thomas Forbes, a research scientist at the National Institute of Standards and Technology (NIST), has been studying pharmaceutical 3D printing using the Quality by Design (QbD) framework adopted by the FDA, which emphasizes that quality controls are put in place from the very beginning. The framework revolves around carefully considering the input materials used (critical material attributes; CMAs), the parameters that affect those materials (critical process parameters; CPPs), and the qualities desired in the outputs (critical quality attributes; CQAs).

In recent work, Dr. Forbes has shown how QbD can be implemented for point-of-care sites using pharmaceutical 3D printing with a drop-on-demand printer for various drugs such as levothyroxine and warfarin. Their measurements characterize the variability in volume and concentration dispensed, which can help guide the creation of effective quality control strategies for pharmaceutical settings. His other work on citalopram tablets quantifies the actual concentrations printed and the variability between tablets using the QbD framework.

There’s an incredible opportunity for a strong collaboration between NIST and 3DP innovators. To handle the extensive catalog of drugs that pharmacies may want to use in printers, effective QA/QC measures must be designed and implemented. Compiling drug validation data and formulating quality measures can be significantly accelerated through partnerships with government research entities that are actively looking to help create standards and datasets that will improve consistency in the field.

What We’re Thinking

The message from our speakers is loud and clear: putting printers in your neighborhood pharmacy is becoming a reality. That change will be brought about by open science, allowing all to build upon it, foolproof and straightforward workflows that make it easy for pharmacists to create networks in a decentralized system, and designing the next generation of quality controls for 3D-printed drugs. The road to widespread adoption will be bumpy, but the four innovators we hosted are taking a proactive approach to such challenges, anticipating and addressing variability and ease-of-use problems along the way to ensure the success of pharmaceutical 3DP. It’s this forward thinking of 3DP innovators that makes us hopeful for what’s to come. Stay tuned for the latest developments by subscribing to 3DHEALS and joining our live events.

About the Author:

Peter Hsu

Peter Hsu

Peter Hsu is an editorial intern for 3DHEALS.  He is currently an undergraduate at the University of Illinois Urbana-Champaign and studies bioengineering with a focus on cell and tissue engineering.  He is also minoring in computer science with interests in artificial intelligence and image processing.  Peter conducts research on using computer vision methods to analyze human tissue images and improving the robustness of machine learning workflows.  He is interested in the use of AI to assist tissue engineering and bioprinting research for medical applications.  He is passionate about science communication and leads STEM outreach lessons at schools in the central Illinois area.

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