3D printing in drug manufacturing: unlocking future possibilities

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XIL Health Founder and CEO Susan Lang believes 3D printed drugs are poised to be the future of pharmacy, with the potential to revolutionize personalized medicine, impact the delivery of drugs and combating infectious diseases as well as sustainability issues.

In 2015, Aprecia Pharmaceuticals’ Spritam Levetiracetam for Seizures became the first 3D printed drug approved by the FDA. The company, of which Lang was a board member, manufactures Spritam using its proprietary ZipDose technology. This allows for rapid disintegration within seconds of coming into contact with a drop of liquid, even at extremely high doses.

Kezia Parkins: What do you think are the main advantages of 3D printed medicines?

Susan Lang: If you think about how we make drugs in the United States, a pharmaceutical company will go to the factory that is going to manufacture their drug and schedule the amount they want to manufacture throughout the year. If there is a drug shortage, because you have to break down this equipment between each drug made, clean it and make sure there is no contamination, the manufacturer cannot comply because it is at full capacity for the year.

The equipment for a 3D printed medicine is much smaller than that of a factory or manufacturing facility, and you can print in small batches. In addition, you have no waste of the active or chemical ingredient. It could really revolutionize the way we deliver and manufacture drugs around the world.

I think 3D printing could be a distributed technology. Just like with MRI or CT scan, you could put a 3D printing center located near major medical centers and different places around the world to enable manufacturing there. If there is a shortage of adjunct treatment for oncology, for example, let an academic center like Harvard print it.

We are not there yet, but just as other computerized technologies have diminished, I am seeing that 3D printers will get smaller and smaller over time and will be amazing at removing waste and being able to locally control the supply chain. supply without safety concerns, such as contamination and counterfeits. .

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For now, it does not replace everything. 3D printing is for solid oral drugs with an active chemical ingredient, but that’s about 96% of everything we take in the United States. For the vast majority of things you put in your mouth and swallow – a pill, capsule, or tablet – it’s technology that could replace what we do today.

KP: What is the potential of 3D printing to transform personalized medicine?

SL: Personalized medicine was born after we mapped the genome. The promise of personalized medicine is that it is genetically specific to the individual. We have not been able to realize this promise in therapeutics, but we do have some in diagnosis.

Part of the reason is that you need very small batch printing. Your genetics are your genetics. There may be cohorts that have similar genetics where you can also have a small batch of printing, but it is impossible to take a large drug factory and suddenly specify it to small groups of people in situations. similar. The cost would be astronomical.

3D printing could offer patients something very new and revolutionary that we have never seen before. I don’t know of any other way, therapeutically, that we can do this that makes economic sense. So we think in the long term, it’s the technology that’s going to make the difference.

KP: Are there specific patient populations that would get the most benefit from 3D printed drugs?

SL: Aprecia is in contact with children’s hospitals which have expressed their interest. They often have very rare disease patients who have small patient populations so being able to print small batches would be great for them.

Second, because Aprecia’s ZipDose technology, where the drug simply evaporates in the mouth with a sip, is a game-changer for children to take medication.

In addition, it is not uncommon for people over the age of 60 or those with certain illnesses to have difficulty swallowing. This is actually a fairly common occurrence. Having a 3D printed medication built into ZipDose technology is very helpful for people who cannot swallow and are worried about taking a lot of pills a day, or are worried about choking so they can keep taking their medication.

Then if you’re thinking of pet medication, giving a cat or dog something that evaporates on their tongue would be great too.

KP: Spritam is still the only 3D printed medicine available. Why is that? What are the regulatory obstacles?

SL: Spritam is what I would call a proof of concept. When you have new technology, you need to get concrete proof that your technology works. It just takes time.

The normal regulatory environment for the FDA has improved significantly over the past five years. Now they get approved quickly, so things are getting to market a lot quicker. For anyone who wants to do 3D printing, now that the technology has a proof of concept, approval of new molecules will be much faster.

I think the issues will not be with FDA approval, but rather with the distribution of the technologies. Does it have to be in a central location with a traditional drug manufacturing plant, or can you create smaller centers? Can the laws follow quickly enough?

Back when I started researching, the whole wall was a computer – now it’s your wristwatch. It’s mind-boggling when you think about how far you’ve come in such a short time. Over the next 10 years, with this technology getting smaller and smaller, how do you tune it in a local setting? You need to make sure that it cannot be used for malicious purposes. There are all kinds of criminal activity in the drug supply chain that you have to watch out for.

For me, these will be some of the challenges, but I think the technology itself will continue to improve and now that the FDA has approved Spritam, I’m pretty confident that the approval process will be faster for the next few drugs to be released. to come. pipeline.

Currently, Aprecia is working with drug manufacturers to review other drugs that may be manufactured on their behalf. Because this is an early stage technology and new to the market, early adopters need to come out and help explain to others what 3D printing can do, how it changes their strategies. in the market and how that makes them more competitive. Aprecia does a very good job in this regard.

KP: How can 3D printed medicines improve health equality around the world?

SL: I think it could democratize who has access to drugs. The Covid-19 is a perfect example. The solution now is a shot, a vaccine, but people are working on pill forms.

Rich countries have access to these drugs much faster than everyone else. If you could distribute this technology, even in a country that has socialized medicine, they can also outsource it to a private drug maker.

You just hope that in the long run these technologies – personalized medicine, small-batch printing, the ability to deliver drugs in times of shortage – could democratize part of the supply chain and distribute it, not just in the United States. , but also globally, to places that don’t have it. It would cost less, allow better local control and better access for patients who really need the drugs.

ZipDose technology that allows the drug to evaporate with a small drop of liquid could also be amazing for developing countries where there may be shortages of good quality water. Also, there are some cultures and religions that don’t take photos so I think this would be an interesting area to explore.

KP: How can 3D printed medicines reduce waste and generally be more sustainable?

SL: I think the sustainability component of all of this is really huge because you don’t have that big equipment breakdown that you have in drug factories just to make a small batch. It’s a lot of work.

Also consider the carbon footprint of moving the supply chain around the world. A lot of the active ingredients come from China, from there they can go to India to be put into pill form, and then they travel elsewhere to be repackaged.

It could totally change the sustainability of this supply chain by removing some of these steps and bringing manufacturing closer to where the drugs are actually used.

KP: How could 3D printed drugs help fight infectious diseases?

SL: I think this is something that could be very important for infectious diseases. We already have treatments for many infectious diseases and many of them are oral solids, like pills to prevent malaria. Again, for anything an oral solid, this is a potential new way to deliver these drugs topically.

KP: What future do you see for 3D printed drugs??

SL: For us, the promise of this will continue to grow as more traditional drug makers come to grips with this technology so they can see what they can do and understand how it fits into their strategy. . This adoption of new technology takes time, but it is absolutely evolving at a much faster rate today than it was five years ago. The next five years, I think, will be amazing to watch.

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