The next wave of personalisation: 3D printing medicines: Part 2
“What we can do is make the drug smarter and breathe life into it”
A menu of printing options
When it comes to designing a new medication, Peels that there are a wide range of parameters that can be varied with 3D printing. Some of the most impactful are listed below:
- Dosing: various dosing levels can be printed, allowing more tailored dosing for patients. This could for example be based on physical parameters such as patient weight. This reduces the need to either split or take multiple pills to achieve the desired dosing level and could result in improved safety and efficacy.
- Combining different active ingredients: Here drugs with different APIs can be printed into the same pill, making it particularly valuable for polypharmacy for patients with multiple chronic conditions. Overall, this helps simplify medication regimens and can improve adherence.
- Release and absorption: changes can be made in the structure and composition of the pill to affect the rate of release and absorption of the drug, e.g., by varying the porosity of the pill. Furthermore, pills can also be designed to release under certain conditions in the body, for example if the Ph in the stomach is above a certain level. By extension, it is possible to combine different APIs and have different release profiles for each component, creating short- and long-term release kinetics in one pill.
- Making pills more palatable: Printers can change the shape, taste, form and texture of a pill to make it easier to swallow. For example, pills can be printed to form gummy-like ‘sweets’ to make it easier for children to consume. Other forms can be made easier to swallow e.g., for patients with oesophageal cancer. Pills can also be printed to have different shapes e.g., with symbols of the sun and moon, or with braille to indicate when they should be taken.
- Nutrition: combining printing technologies with nutrition, whether as supplements or indeed printing medication directly onto the food itself, may prove another option for making administration simpler.
With all these options, Peels highlights the potential for thinking about existing medications in completely new ways. For example, a medicine about to lose exclusivity could be tailored to the needs of a specific sub-population e.g., through changing release and absorption properties. Such changes could be patented and enable the company to extend the life of the asset, whilst simultaneously improving patient outcomes.
The challenge of innovation: achieving scale
Peels highlights there are four main challenges to getting 3D printing of medicines at scale:
- Cost: 3D printing is likely to remain more costly than large scale manufacturing due to the differences in scale economies. The key here for 3D printing will be to demonstrate cost effectiveness, either by improving patient outcomes and or by reducing pharmacy costs. To win the argument, companies will need to produce evidence on the impact of their technology, such as patient outcome or health economic studies.
“Quality control is going to be a problem, but this will not deter the industry because they will end up solving this.”
- Quality control: whilst major influence on scalability, Peels expects this to be addressed by industry players. Ensuring replicability is critical, given so much variation in the technology. Peels believes that with inkjet printing we can get a high degree of reliability and repeatability, but we still have some way to go with other approaches.
- Limited number of suppliers of equipment: There are very few GMP ready devices that can print pills. Peels estimates there are approximately 6 such model printers available as of today, with up to 20 models available should they be repurposed for printing medicines. This ultimately constrains how much production can be industrialised. 10,000 patients is key the volume threshold for Peels. Beyond this, manufacturers are likely to supply experience constraints.
“The FDA has been very willing to work with us as an industry”
- Regulatory environment: Peels highlights the very positive developments that the FDA has been making in order to support the uptake of additive manufacturing and 3D printing. They have engaged the sector well and are keen for the US to be world leaders in this area. Europe as well as independent countries have been slower to respond. There are two key challenges facing regulators:
- Availability of good quality, long-term data to support the efficacy and safety claims of these personalised therapies
- Having a suitable regulatory framework for covering the range of therapies e.g., distributed manufacturing, personalised combinations of drugs and devices, etc
How pharma and biotech companies can capitalise from this technology
Peels has four specific recommendations for drug developers in this space:
- Explore implementing 3D printing options for testing, discovery and process improvement. This could include developing proprietary 3D printing devices. This should help reduce costs, reduce cycle times and accelerate drugs to market.
- Apply 3D printing solutions to extend the patent life of marketed products. Through the types of modifications described above, drug manufacturers may be able to better serve specific patient segments than its competitors. Peels believes there is strong patent potential here for many companies.
“There is enormous potential for repurposing existing medicines with 3D printing”
- Repurpose existing treatments: 3D could result in new uses / therapeutic indications for marketed products once considered too difficult in the past or still to this date unexplored. This could include repurposing drugs for very large patient populations e.g., paediatric or elderly patients.
- Rethink your interactions with hospital pharmacists: 3D printers are already being used for research purposes in specialist hospital pharmacies and with time we are likely to see their routine use for individual compounding tasks. This is likely to start in the specialised hospitals and grow from there. The hospital pharmacist will be a key stakeholder for drug developers in the ‘personalised’ supply chain and therefore strong relationships will be vital.
