Merck KGaA has partnered with German tech company AMCM to carry out clinical testing on tablets manufactured using 3D printing.
The collaboration – which could be a “massive move towards digitalization of the industry,” according to Merck’s chief strategy officer Isabel de Paoli – will focus initially on formulation development and production of 3D printed tablets for clinical trials.
Merck and AMCM – part of the metal and polymer 3D printing specialist EOS group – are working on the development of a prototype tablet printer that they hope will be ready for testing later this year.
3D printing has already reached the commercial stage in pharma, after Aprecia Pharmaceuticals claimed FDA approval for its epilepsy therapy Spritam (levetiracetam) in 2015.
3D printing was pioneered way back in 1986 but has recently begun to enter the public consciousness. Over the past ten years, it has blurred the boundaries between science fiction and fact. It is also known as Additive Manufacturing and is used in the automobile industry, aerospace & defence, retail and in the medical healthcare industry, amongst many others. A major component of this is the 3D printed drugs market. 3D printing helps make what was once expensive and inaccessible much more cost-effective. Can this be more apt and necessary anywhere else than in the field of medicine? 3D printing is already used to print artificial bones, to create surgical materials with 3D scans to replace a damaged or missing bone and even to create hearing aid devices. Skull implants have been made for people with head injuries and even titanium heels to replace bone cancer afflicted patients.
3D-Printed Drugs Market Drivers – There are several factors which help the 3D printed drugs market to grow. One key advantage is their instantaneous solubility. 3D printed drugs are produced using powder bed inkjet printing. The elements of the drug are added in a layer by layer approach akin to 3D printing for any other device. This makes the drugs easier to swallow and can be very helpful for patients suffering from dysphagia. 3D printing could also augment the arrival of individualised drugs, or the creation of a combination of drugs. They could be customised for each patient, which would help much more than batch-produced drugs since they would be created specifically taking into account that patient’s medical history. The 3D printed drug market could also make children far less resistant to taking their required medication, since they may be able to choose the shape, colour, design and even taste of the tablet! These are anticipated to be the main drivers of the 3D printed drug market.
3D printing is transforming certain industries – so why hasn’t it been widely adopted in the pharma sector? There are likely to be a number of barriers to entry for 3D printing in this field, including identifying how to make it economically viable. Whilst a number of the key patents relating to 3D printing have expired and certain 3D printers have become cheaper, the printers and inks required for the 3D printing of pills are not yet readily or cheaply available. In addition, 3D printed pills are still being researched. Even when these challenges are overcome there is the further potential difficulty of changing the supply chain; switching from centralised to local manufacture and the supply of “inks” to enable the 3D printing of a pill instead of the pill itself.
However, as can be seen from some of the opportunities that this technology provides, there doesn’t have to be an all-or-nothing adoption of 3D printing; it can be used to complement a company’s existing manufacturing techniques.
Decades ago, we used to say technology was the wave of the future. Today, with technologies such as additive manufacturing, we are living in the future.
Additive manufacturing, or 3D printing, is being used increasingly across numerous industries, from automotive to entertainment to pharmaceutical and medical device.
According to a recent report, North America is expected to account for the largest share of the global 3D printing medical device market in 2017, a global market which is projected to reach USD 1.88 billion by 2022 from USD 0.84 billion in 2017.
While 3D printing is here, the future holds many questions. As the use of 3D printing continues to expand in the pharmaceutical and medical device space, how the FDA regulatory regime and traditional products liability principles will evolve are among these questions.
Three-dimensional (3D) printing—a type of additive manufacturing (AM)—has the potential to be the “next great step” in pharmaceutical manufacturing, enabling fabrication of specialty drugs and medical devices, said Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the 2016 CPhI Annual Industry Report. 3D printing could be used for personalized or unique dosage forms, more complex drug-release profiles, and printing living tissue, noted Ciurczak in the report.
Because 3D printing builds an object layer by layer, it could be used to print drug tablets with a personalized dosage, possibly combining multiple drugs into a single dose. Printing a barrier between APIs in a multilayer tablet could facilitate targeted and controlled drug release. Ciurczak proposed some applications where 3D printing could be of benefit. Orphan drugs, for example, may be limited because their market is too small to justify production costs, but a 3D printing process could minimize the cost. Another possible use is for making tablets to calibrate dissolution testers for United States Pharmacopeia testing. Ciurczak suggested that 3D printing could allow these tablets to be made in smaller lots, as needed, rather than once every few years, which could improve reproducibility. Products that would benefit from the lack of high compressive forces in 3D printing of tablets, such as abuse-proof tablets, may be another opportunity.
In the year 2000, the music business was still strong. Record companies produced albums and shipped these physical objects to the stores that sold them. The internet was slowly becoming a system of mass consumption and distribution, but most consumers still purchased physical media. And while the record industry was aware of piracy online, the threat seemed minimal.
Then came Napster.
The music industry tried to stop this large-scale piracy by pursuing both the platforms and individual downloaders — including poor college students. But public opinion turned against the industry. After all, stealing digital music is intangible; it’s different than physically swiping actual CDs or tapes from brick-and-mortar stores. And while today many people access their music legally, it’s safe to say that music industry revenues have yet to recover.