By: Sakthi Prasad --
18 August, 2015
In collaboration with Meenakshi L, Lead Analyst, Pharma R&D
In August, the FDA approved the first ever 3D printed drug Spritam -- an anti-epileptic medicine developed by Aprecia Pharmaceuticals.
Aprecia uses ZipDose Technology platform that enables delivery of a high drug load, up to 1000 mg in a single dose.
FDA had previously approved medical devices and prosthetics developed by additive manufacturing technologies, but the approval of Spritam marks a new era in the manufacturing of tablets.
As Prof Lee Cronin of University of Glasgow said in a 2012 TED talk, "the idea is that we want to have a universal set of inks that we put out with the printer, and you download the blueprint, the organic chemistry for that molecule and you make it in the device. And so you can make your molecule in the printer using this software." (http://beroeinc.co/1WE58qS)
In other words, this technology can potentially "democratise" the manufacturing of medicines, though it may not pan out as a cottage industry anytime soon.
3D printing (3DP) is a process of making three dimensional (3D) solid objects from a digital model. The methodology uses an additive process, where successive layers of material are laid down in different shapes.
This revolutionary printing technology is beginning to find applications across multiple avenues within the healthcare industry. The applications include but not limited to device, prosthetics, tissues and organs.
This technology will surely feature in the radar of contract manufacturers, who produce billions of dollars worth of medicines on behalf of their pharma clients.
Besides manufacturing, pharmaceutical R&D can also experience a big change because of 3DP. In fact, Organovo, a biotechnology firm based in La Jolla, manufactures 3D liver using bio-printing technology that is employed to test effectiveness and safety of drugs.
Below are several other implications of 3DP:
1. Custom manufacture of drug dosages: One can manufacture multiple dosages of the same drug to suit the needs of a patient. This comes in handy especially in case of rare diseases, where the severity of the ailment is varied in a small patient pool.
2. Multiple API's manufactured from same machine with little or no down time: The Howard Hughes Medical Institute has developed a 3D printer that can synthesise and fabricate up to 14 different APIs from same raw materials and building blocks. Although the scale is currently in "mg to g" range, given the growth in innovation in this dynamic technology space, the day is not far for commercial scale manufacture.
3. One stop shop: Unlike traditional manufacturing process that requires a plethora of equipment for various processes involved in development of an API, all the chemical processes and subsequent reactions can be completed within a single 3D printing machine.
4. Direct-To-Consumer (DTC) Drugs: 3D printing offers an opportunity for manufacturing the drug at doctor's office, which does not require large scale packaging, logistics and distribution. This can upend manufacturing and distribution supply chain.
5. Clinical Trial Manufacture: Clinical trial drug formulation and manufacture is a very crucial step in drug development. This segment of investigative new drug manufacture is very rarely outsourced. At this stage, the final formulation and dosage are still under development. As a result, the focus on speed, agility, quality and scientific expertise are of prime importance. 3D printing can bring in agility, automation and option of multiple formulation/dosage manufacture at lower capital expense over a period of time.
The chief hurdle for utilizing 3D printing in clinical trial manufacture is the approval from FDA. However, considering the precedent set by the regulatory agency, this technology may soon make inroads into clinical trial manufacture.