XIL Health founder and CEO Susan Lang believes that 3D-printed drugs are poised to be the future of pharma, offering the potential to revolutionise personalised medicine, impact drug distribution and tackle 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 firm, of which Lang was a board member, makes 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 see as some of the main benefits of 3D-printed drugs?
Susan Lang: If you think about the way we manufacture drugs in the US, a pharma company will go to the plant that is going to manufacture their drug and schedule the amount they want to make throughout the year. If there is a shortage of the drug, because you have to break down that equipment in between every single drug that’s manufactured, clean it and make sure there’s no contamination, the manufacturer can’t comply because they are at capacity for the year.
Equipment for a 3D-printed drug is much smaller than that of a factory or manufacturing plant and you can print in small batches. Plus, you don’t have any waste of the active or chemical ingredient. It could really revolutionise the way we deliver and manufacture drugs around the world.
I believe 3D printing could be a distributed technology. Just like with MRI or CAT scan, you could put a 3D printing centre located close to major medical centres and different places around the world to allow manufacture there. If there are shortages of an adjunct therapy for oncology, for example, let an academic centre like Harvard print it.
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We are not there yet, but just as other computerised technologies have shrunk, I see that 3D printers will get smaller and smaller over time and be amazing in eliminating waste and being able to locally control the supply chain without security issues, like contamination and fakes.
Right now, it doesn’t replace everything. 3D printing is for oral solid medications that have an active chemical ingredient – but that’s around 96% of everything that we take in the US. For the vast majority of things that you put in your mouth and swallow – a pill, capsule or tablet – this is a technology that could replace what we do today.
KP: What is 3D printing’s potential to transform personalised medicine?
SL: Personalised medicine came about after we mapped the genome. The promise of personalised medicine is that it’s genetically specific to the individual. We have not been able to realise that promise in therapeutics but have a little bit in diagnostics.
Part of the reason is, 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’s impossible to take a large drug manufacturing plant and suddenly specify that to small groups of people in similar situations. The cost would be astronomical.
3D printing could deliver patients something very novel and revolutionary that we haven’t seen before. I don’t know any other way, therapeutically, that we’re going to be able to do this that makes sense economically. So, we think long term, this is the technology that is going to make a difference.
KP: Are there any specific patient populations that would best benefit from 3D-printed drugs?
SL: Aprecia is in touch with children’s hospitals that have expressed interest. They often have patients with very rare diseases which have small patient populations, so being able to print small batches would be great for them.
Then because Aprecia’s ZipDose technology, where the drug just evaporates in the mouth with a sip, is just game-changing for kids being able to take medicine.
Also, it’s not uncommon for folks over 60 or those that have certain diseases to have trouble swallowing. It’s actually a pretty common phenomenon. Having a 3D-printed drug embedded in ZipDose technology is very helpful for people that can’t swallow and are fearful of taking lots of pills a day, or worried about choking so they can stay on their medications.
Then if you think about pet meds, giving a cat or dog something that evaporates on their tongue would also be tremendous.
KP: Spritam is still the only 3D-printed drug available. Why is that? What are the regulatory hurdles?
SL: Spritam is what I would call a proof of concept. When you have a new technology, you need to get real-world evidence that your technology works. That just takes time.
The normal regulatory environment at the FDA has improved a lot over the last five years. Now they’re doing rapid approval, so things are getting in the market much more quickly. For anybody who wants to do 3D printing, now that the technology has a proof of concept, getting new molecules approved will be much quicker.
I think the issues will not be around FDA approval, but rather around distributing technologies. Does it have to be in a central location with a traditional drug manufacturing plant, or can you set up smaller centres? Can the laws keep up quick enough?
Back when I started out in research, the whole wall was a computer – now, it’s your wristwatch. It’s mind-boggling when you think about how far we’ve come in a short period of time. In the next 10 years, with this technology becoming smaller in size, how do you regulate it in a local setting? You’ve got to make sure it cannot be used for nefarious purposes. There are all kinds of criminal activities within the drug supply chain that you have to be careful about.
To me, those are going to be some of the challenges, but I think the technology itself will continue to improve and now that the FDA has approved Spritam, I feel pretty confident that the approval process will be quicker for the next drugs coming down the pipeline.
Right now, Aprecia is working with drug manufacturers to look at other drugs that could be manufactured on their behalf. Because it’s an early-stage technology and it’s new in the market, early adopters have to go out and help explain to others what 3D printing can do, how this changes their strategies in the market and how it makes them more competitive. Aprecia is doing a really great job of that.
KP: How can 3D-printed drugs improve global health equality?
SL: I do think it could democratise who gets access to drugs. Covid-19 is a perfect example. The solution now is a shot, a vaccine, but people are working on pill forms.
Wealthy countries get access to these medicines much quicker than everyone else. If you could distribute this technology, even in a country that has socialised medicine, they can also outsource that to a private drug manufacturer.
You would just hope that, in the long term, these technologies – personalised medicine, small-batch printing, being able to supply drugs when there’s a shortage – could democratise some of the supply chain and distribute it, not just within the US but also globally, to places that don’t have it. It would be less expensive, allow more local control, and more access for patients that really need medications.
ZipDose technology that allows the medication to evaporate with a tiny drop of liquid could also be amazing for developing countries where there may be shortages of good water. Also, there are some cultures and religions that won’t take shots so I think that that would be an interesting area to explore.
KP: How can 3D-printed drugs reduce waste and be generally more sustainable?
SL: I think the sustainability component of this is really tremendous because you don’t have that big breakdown of equipment that you have at drug manufacturing plants just to do a small batch. That’s lots of work.
Also, think about the carbon footprint of moving the supply chain around the world. A lot of active ingredients come from China, from there it may go to India to be put in pill form, then it moves somewhere else to get repackaged.
It could totally change that supply chain sustainability by cutting out some of those steps and making the manufacturing closer to where the drugs are actually used.
KP: How could 3D-printed drugs help in the response to infectious diseases?
SL: I think this is something that could be really important for infectious diseases. We already have treatments for many infectious diseases and a lot of those are oral solids, like pills to prevent malaria. Again, for anything that’s an oral solid, this is a potential new way to deliver those drugs locally.
KP: What do you see in the future for 3D-printed drugs?
SL: For us, the promise of this is just going to keep growing as we get more of the traditional drug manufacturers in front of this technology so they can see what they can do and understand how it fits in with their strategy. That adoption of new technology takes time, but it is absolutely moving at a much more rapid pace now than it was five years ago. The next five years, I think, will be amazing to watch.