Merck KGaA, a German multinational pharmaceutical, chemical, and life sciences company headquartered in Darmstadt has announced a partnership with Additive Manufacturing Customized Machines (AMCM), a member of metals and polymers 3D printing company, EOS Group. The partnership has as its objective to develop and produce 3D-printed drug products.
The initial stage of the partnership will be to develop a prototype 3D drug or tablet printer. Work on the development of the printer is expected to be completed towards the end of 2020 as a spokesperson for Merck hinted.
As a beta testing stage for the project, the collaboration will work on supplying 3D printed drugs in tablet form to clinical trial-sized groups, eventually putting resources and equipment together for manufacturing for commercial purposes
The collaboration will not only benefit both parties, as the project also aims to render 3D printing drug services to interested clients. To accomplish this, the duo plans to establish a contract development and manufacturing organization (CDMO) as a platform to provide these services to the pharmaceutical industry.
The spokesperson commented on the types of tablets that can be formulated with this process, saying that Merck is using laser sintering, an additive manufacturing technique which is “the leading industrial 3D printing technology.” This technology will enable tablet production for a ‘broad variety’ of indications and active pharmaceutical ingredients (APIs).
Application of 3D printing technology to drug manufacturing is achieved through a ‘simplified’ process, utilizing powder bed fusion methods, whereby a laser melts and fuses powder together layer by layer, the companies explained. This process allows for scalable and cost-effective reformulations throughout the entire process.
The partnership could ‘revolutionize’ the way tablets are produced, marking a move towards digitalization of drug manufacturing, says Isabel de Paoli, chief strategy officer at Merck.
A 3D printed drug, Spritam (levetiracetam), developed by Aprecia Pharmaceuticals, is available on the market since it was approved by the US Food and Drug Administration in 2015.
However, Merck’s spokesperson told us that the collaboration with AMCM aims to utilize laser sintering to develop a broadly applicable 3D printing technology for tablet manufacturing.