A cooperation agreement will see Merck KGaA work with Additive Manufacturing Customized Machines (AMCM), a member of metals and polymers 3D printing company, EOS Group, with the project taking place at the Innovation Center at Merck headquarters in Darmstadt, Germany.
A spokesperson for Merck told us that the first step of the collaboration will be to develop a prototype printer, which is expected to be completed towards the end of 2020.
The partners will initially develop and produce 3D-printed drug products in tablet formulation to be supplied to clinical trials, while also looking to build a manufacturing service for commercial purposes.
Specifically, according to the spokesperson, the partners aim to establish a contract development and manufacturing organization (CDMO) to provide 3D-printed tablet formulation development and production services to the pharmaceutical industry.
Asked about the types of drugs that can be formulated with the technology, the spokesperson told us 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.
Benefits of this technology include that the API formulation can be scalable, avoiding costly reformulations throughout the entire process, ultimately saving manufacturers time and costs, according to Merck.
Isabel de Paoli, chief strategy officer at Merck, commented that the partnership could ‘revolutionize’ the way tablets are produced, marking a move towards digitalization of drug manufacturing.
On her side, Marie Langer, CEO of EOS, stated that the cooperation combines Merck’s formulation and excipients expertise with EOS additive manufacturing capabilities, aiming to increase flexibility and shorten timeframes in drug development.
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.